innovative key to product patent in pharmaceutical industry



Junaid Javaid Marketing Research . Innovative Product Launch in Indian Sanitation Industry Junaid Javaid Marketing Research . Innovative Product Launch in Indian Sanitation Industry Новинка

Junaid Javaid Marketing Research . Innovative Product Launch in Indian Sanitation Industry

Project Report from the year 2014 in the subject Business economics - Marketing, Corporate Communication, CRM, Market Research, Social Media, grade: B, University of Bedfordshire, course: MASTER OF BUSINESS ADMINISTRATION, language: English, abstract: This report on the topic of launch of Innovative Product within Indian Sanitation Industry. The scope of this report is broad. It has been discovered that innovation in marketing offering (products or services) managed to command top attention from the majority of CEOs. Innovation in product is considered as major opportunities for the purpose of making customers loyal to the specified brand. There is no doubt in saying that Indian Sanitation industry has been growing on consistent basis and also promising great potential for future prospect as well. By analysing, all forces of Porter Five Forces model, it has been inclined that Indian Sanitation industry is attractive and has potential for growth in the long term. It has been discovered with the help of PESTLE analysis that there are two aspects (Sociological & Environmental) that could pose threat to the Indian Sanitation industry while the other four aspects (Political, Economical, Technological and Legislative) would be seen as great opportunities for the Indian Sanitation industry. DG Corporation (Entrepreneur Business Idea) is Indian based company and is thinking of entering Indian Sanitation industry with its innovative product named as DG Solar Glass Sanitizer. The c...
John LaMattina L. Devalued and Distrusted. Can the Pharmaceutical Industry Restore its Broken Image? John LaMattina L. Devalued and Distrusted. Can the Pharmaceutical Industry Restore its Broken Image? Новинка

John LaMattina L. Devalued and Distrusted. Can the Pharmaceutical Industry Restore its Broken Image?

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An expert's view on solving the challenges confronting today's pharmaceutical industry Author John LaMattina, a thirty-year veteran of the pharmaceutical industry and former president of Pfizer's Global R&D Division, is internationally recognized as an expert on the pharmaceutical industry. His first book, Drug Truths: Dispelling the Myths About Pharma R&D, was critically acclaimed for clearing up misconceptions about the pharmaceutical industry and providing an honest account of the contributions of pharmaceutical research and development to human health and well-being. As he toured the country discussing Drug Truths, Dr. LaMattina regularly came across people who were filled with anger, accusing the pharmaceutical industry of making up diseases, hiding dangerous side effects, and more. This book was written in response to that experience, critically examining public perceptions and industry realities. Starting with «4 Secrets that Drug Companies Don't Want You to Know,» Devalued and Distrusted provides a fact-based account of how the pharmaceutical industry works and the challenges it faces. It addresses such critical issues as: Why pharmaceutical R&D productivity has declined Where pharmaceutical companies need to invest their resources What can be done to solve core health challenges, including cancer, diabetes, and neurodegenerative diseases How the pharmaceutical industry can regain public trust and resuscitate its image Our understanding of human health and disease grows daily; however, converting science into medicine is increasingly challenging. Reading Devalued and Distrusted, you'll not only gain a greater appreciation of those challenges, but also the role that the pharmaceutical industry currently plays and can play in solving those challenges. Get to know the author: Read an interview with John LaMattina or watch a video on ChemistryViews! Interview: John LaMattina: 30 Years in Pharma Video: Can the Pharmaceutical Industry Restory its Broken Image?
Andreas Liese Biocatalysis for the Pharmaceutical Industry. Discovery, Development, and Manufacturing Andreas Liese Biocatalysis for the Pharmaceutical Industry. Discovery, Development, and Manufacturing Новинка

Andreas Liese Biocatalysis for the Pharmaceutical Industry. Discovery, Development, and Manufacturing

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Biocatalysis is rapidly evolving into a key technology for the discovery and production of chemicals, especially in the pharmaceutical industry, where high yielding chemo-, regio-, and enantioselective reactions are critical. Taking the latest breakthroughs in genomics and proteomics into consideration, Biocatalysis for the Pharmaceutical Industry concisely yet comprehensively discusses the modern application of biocatalysis to drug discovery, development, and manufacturing. Written by a team of leading experts, the book offers deep insight into this cutting edge field. Covers a wide range of topics in a systematic manner with an emphasis on industrial applications Provides a thorough introduction to the latest biocatalysts, modern expression hosts, state-of-the-art directed evolution, high throughput screening, and bioprocess engineering Addresses frontier subjects such as emerging enzymes, metabolite profiling, combinatorial biosynthesis, metabolic engineering, and autonomous enzymes for the synthesis and development of chiral molecules, drug metabolites, and semi-synthetic medicinal compounds and natural product analogs Highlights the impact of biocatalysis on green chemistry Contains numerous graphics to illustrate concepts and techniques Biocatalysis for the Pharmaceutical Industry is an essential resource for scientists, engineers, and R&D policy makers in the fine chemical, pharmaceutical, and biotech industries. It is also an invaluable tool for academic researchers and advanced students of organic and materials synthesis, chemical biology, and medicinal chemistry.
Dipak Kumar Sarker Pharmaceutical Emulsions. A Drug Developer's Toolbag Dipak Kumar Sarker Pharmaceutical Emulsions. A Drug Developer's Toolbag Новинка

Dipak Kumar Sarker Pharmaceutical Emulsions. A Drug Developer's Toolbag

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Pharmaceutical Emulsions: A Drug Developer's Toolbag covers all the key aspects of pharmaceutical emulsions, starting from the fundamental scientific basics, to the pharmaceutical forms and the chemical tests for its application. The author uses his extensive experience in both industry and academic experience to provide a concise, student friendly guide to the essential fundamentals of physical pharmacy. Divided into three clear sections, the text begins with Section A – Consideration for Product: Medicinal Formulation which includes a historical perspective, explanation of what is an emulsion, stability and instability, and manufacture. Section B – Forms, Use and Application follows, with chapters on creams and ointments, pastes and bases, colloids, transdermal, gels and implants. The final Section, Tests: Chemistry to control the quality, efficacy and fitness for purpose of the product includes chapters on physic-chemical properties, sizing and microscopy, rheology, QC and finally questions, calculations and dilemmas. Throughout the text there are numerous figures, diagrams and tables to engage the reader. This is an invaluable reference for all students of pharmaceutical sciences, pharmacy industrial pharmaceutical sciences, physical pharmacy and pharmaceutical forms as well as industry professionals
Wilfried Rahse Industrial Product Design of Solids and Liquids. A Practical Guide Wilfried Rahse Industrial Product Design of Solids and Liquids. A Practical Guide Новинка

Wilfried Rahse Industrial Product Design of Solids and Liquids. A Practical Guide

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Offering invaluable insights from a chemist with over 35 years experience in the industry, this practical guide incorporates numerous practical examples and case studies to explain the concepts included here. The author explains the processes involved in product design, how to set up experiments, and ultimately how to scale-up. Among the host of topics covered is a discussion of recent advances in the fundamentals and innovative technologies leading to new and improved products. Industrial Product Design of Solids and Liquids: A Practical Guide is essential reading for the pharmaceutical, cosmetics and personal care, food, fragrance, paints, plastics and agricultural industries.
Ann Newman Pharmaceutical Amorphous Solid Dispersions Ann Newman Pharmaceutical Amorphous Solid Dispersions Новинка

Ann Newman Pharmaceutical Amorphous Solid Dispersions

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Providing a roadmap from early to late stages of drug development, this book overviews amorphous solid dispersion technology – a leading platform to deliver poorly water soluble drugs, a major hurdle in today’s pharmaceutical industry. • Helps readers understand amorphous solid dispersions and apply techniques to particular pharmaceutical systems • Covers physical and chemical properties, screening, scale-up, formulation, drug product manufacture, intellectual property, and regulatory considerations • Has an appendix with structure and property information for polymers commonly used in drug development and with marketed drugs developed using the amorphous sold dispersion approach • Addresses global regulatory issues including USA regulations, ICH guidelines, and patent concerns around the world
Jack Shostak SAS Programming in the Pharmaceutical Industry, Second Edition Jack Shostak SAS Programming in the Pharmaceutical Industry, Second Edition Новинка

Jack Shostak SAS Programming in the Pharmaceutical Industry, Second Edition

This comprehensive resource provides on-the-job training for statistical programmers who use SAS in the pharmaceutical industryThis one-stop resource offers a complete review of what entry- to intermediate-level statistical programmers need to know in order to help with the analysis and reporting of clinical trial data in the pharmaceutical industry. SAS Programming in the Pharmaceutical Industry, Second Edition begins with an introduction to the pharmaceutical industry and the work environment of a statistical programmer. Then it gives a chronological explanation of what you need to know to do the job. It includes information on importing and massaging data into analysis data sets, producing clinical trial output, and exporting data. This edition has been updated for SAS 9.4, and it features new graphics as well as all new examples using CDISC SDTM or ADaM model data structures.Whether you're a novice seeking an introduction to SAS programming in the pharmaceutical industry or a junior-level programmer exploring new approaches to problem solving, this real-world reference guide offers a wealth of practical suggestions to help you sharpen your skills. This book is part of the SAS Press program.
Axel Jörn Pfizer and the Challenges of the Global Pharmaceutical Industry Axel Jörn Pfizer and the Challenges of the Global Pharmaceutical Industry Новинка

Axel Jörn Pfizer and the Challenges of the Global Pharmaceutical Industry

This Case Study defines the global pharmaceutical industry and its „boundaries", analyses the profitability/attractiveness of the global pharmaceutical industry by using M.E.Porters' Five-Forces-Model and answers the questions what overall industry trends can be identified and how the profitability/attractiveness of the industry will change in the future. Furthermore it explains and evaluates Pfizer's new strategy and examines what Pfizer did in the recent years to maintain their profitability.
Murad Ferid Collaborative Innovation in Drug Discovery. Strategies for Public and Private Partnerships Murad Ferid Collaborative Innovation in Drug Discovery. Strategies for Public and Private Partnerships Новинка

Murad Ferid Collaborative Innovation in Drug Discovery. Strategies for Public and Private Partnerships

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Can academia save the pharmaceutical industry? The pharmaceutical industry is at a crossroads. The urgent need for novel therapies cannot stem the skyrocketing costs and plummeting productivity plaguing R&D, and many key products are facing patent expiration. Dr. Rathnam Chaguturu presents a case for collaboration between the pharmaceutical industry and academia that could reverse the industry's decline. Collaborative Innovation in Drug Discovery: Strategies for Public and Private Partnerships provides insight into the potential synergy of basing R&D in academia while leaving drug companies to turn hits into marketable products. As Founder and CEO of iDDPartners, focused on pharmaceutical innovation, Founding president of the International Chemical Biology Society, and Senior Director-Discovery Sciences, SRI International, Dr. Chaguturu has assembled a panel of experts from around the world to weigh in on issues that affect the two driving forces in medical advancement. Gain global perspectives on the benefits and potential issues surrounding collaborative innovation Discover how industries can come together to prevent another «Pharma Cliff» Learn how nonprofits are becoming the driving force behind innovation Read case studies of specific academia-pharma partnerships for real-life examples of successful collaboration Explore government initiatives that help foster cooperation between industry and academia Dr. Chaguturu’s thirty-five years of experience in academia and industry, managing new lead discovery projects and forging collaborative partnerships with academia, disease foundations, nonprofits, and government agencies lend him an informative perspective into the issues facing pharmaceutical progress. In Collaborative Innovation in Drug Discovery: Strategies for Public and Private Partnerships, he and his expert team provide insight into the various nuances of the debate.
Rolf Hilfiker Polymorphism in the Pharmaceutical Industry. Solid Form and Drug Development Rolf Hilfiker Polymorphism in the Pharmaceutical Industry. Solid Form and Drug Development Новинка

Rolf Hilfiker Polymorphism in the Pharmaceutical Industry. Solid Form and Drug Development

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Polymorphism in the Pharmaceutical Industry – Solid Form and Drug Development highlights the relevance of polymorphism in modern pharmaceutical chemistry, with a focus on quality by design (QbD) concepts. It covers all important issues by way of case studies, ranging from properties and crystallization, via thermodynamics, analytics and theoretical modelling right up to patent issues. As such, the book underscores the importance of solid-state chemistry within chemical and pharmaceutical development. It emphasizes why solid-state issues are important, the approaches needed to avoid problems and the opportunities offered by solid-state properties. The authors include true polymorphs as well as solvates and hydrates, while providing information on physicochemical properties, crystallization thermodynamics, quantum-mechanical modelling, and up-scaling. Important analytical tools to characterize solid-state forms and to quantify mixtures are summarized, and case studies on solid-state development processes in industry are also provided. Written by acknowledged experts in the field, this is a high-quality reference for researchers, project managers and quality assurance managers in pharmaceutical, agrochemical and fine chemical companies as well as for academics and newcomers to organic solid-state chemistry.
Bond Terry Computer-Aided Pattern Design and Product Development Bond Terry Computer-Aided Pattern Design and Product Development Новинка

Bond Terry Computer-Aided Pattern Design and Product Development

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The use of computers has opened up remarkable opportunities for innovative design, improved productivity, and greater efficiency in the use of materials. Uniquely, this book focuses on the practical use of computers for clothing pattern design and product development. Readers are introduced to the various computer systems which are suitable for the industry, the principles and techniques of pattern design applied to computer systems are explained, and readers are shown how product data management can be used in clothing product development.
Norbert Waldy CE marking for machinery and partly completed machinery Norbert Waldy CE marking for machinery and partly completed machinery Новинка

Norbert Waldy CE marking for machinery and partly completed machinery

The author, Norbert Waldy, has developed since the 1980s different safety procedures for machinery manufacturing in order to increase security standards. He has invariably focused his attention on the practical aspect and always believed that self-explanatory check lists were the key to success. After 10 years in the pharmaceutical industry in which he had the occasion to qualify, validate and monitor complex pharmaceutical facilities as Head of Department, he decided to transmit his knowledge with this book.
Stefan Kirchner Pharmaceutical Intellectual Property Rights and the Single Market Stefan Kirchner Pharmaceutical Intellectual Property Rights and the Single Market Новинка

Stefan Kirchner Pharmaceutical Intellectual Property Rights and the Single Market

Thesis (M.A.) from the year 2006 in the subject Law - European and International Law, Intellectual Properties, grade: 13,53 (gut) , Justus-Liebig-University Giessen, course: Magister Juris Internationalis, language: English, abstract: With an aging demographic all over the European Union, the European pharmaceutical sector is set to grow in the coming decades. Al-ready today the pharmaceutical industry is a key employer in Europe. At the same time, the pharmaceutical industry is marked by a very ex-pensive research and development phase, which makes strong intellectual property rights crucial to ensure that research for new pharmaceuticals remains commercially interesting. But not only direct threats to intellectual property rights, such as the production of generic phar-maceuticals or the sale of counterfeit pharmaceuticals, pose a threat to those pharmaceutical companies which heavily invest in research for the development of new products: different prices for identical pharmaceuticals in different member states of the European Community make it economically interesting to buy pharmaceuticals in one member state and sell them abroad. It might even be cheaper to sell reimported pharmaceuticals in the country of origin. This possibility opens a whole new market for reimporters which cuts directly into the profit of the producers. In this thesis we will look at different issues surrounding intellectual property rights in the European pharmaceutical sector by investigating the ...
Dennis Jenke Compatibility of Pharmaceutical Solutions and Contact Materials. Safety Assessments of Extractables and Leachables for Pharmaceutical Products Dennis Jenke Compatibility of Pharmaceutical Solutions and Contact Materials. Safety Assessments of Extractables and Leachables for Pharmaceutical Products Новинка

Dennis Jenke Compatibility of Pharmaceutical Solutions and Contact Materials. Safety Assessments of Extractables and Leachables for Pharmaceutical Products

10587.43 руб. или Купить в рассрочку!
Compatibility of Pharmaceutical Products and Contact Materials Dennis Jenke Important safety aspects of compatibility for therapeutic products and their manufacturing systems, delivery devices, and containers Compatibility of Pharmaceutical Products and Contact Materials helps pharmaceutical, toxicology, analytical, and regulatory affairs professionals assess the safety of leachable and extractable chemicals associated with drug product packaging, manufacturing systems, and devices. The most comprehensive resource available, its coverage includes the strategies, tactics, and regulatory requirements for performing safety assessments, along with the means for interpreting results. Structured around a logical framework for an extractables and leachables safety assessment and closely linked to the pharmaceutical product development process, Compatibility of Pharmaceutical Products and Contact Materials directly addresses the fundamental questions of «what activities need to be performed to completely, efficiently, and effectively address the issue of product safety from an extractables and leachables perspective?» and «when do the various required activities need to be performed?» Specifically, the chapters describe: Pertinent regulations and practical ways to meet guidelines Coordinating manufacturing, storage, and delivery systems development and qualification with therapeutic product development Materials characterization and the materials screening process Component and/or system qualification (illustrated by several case studies) Performing validation/migration studies and interpreting and reporting the results Creating a product registration dossier and putting it through regulatory review Product maintenance (Change Control) from an extractables and leachables perspective Likely future developments in extractables and leachables assessment Additionally, the book's appendix provides a database, including CAS registry numbers, chemical formulas and molecular weights of extractable/leachable substances that have been reported in the chemical literature. Detailing the interconnected roles played by analytical chemistry, biological science, toxicology, and regulatory science, Compatibility of Pharmaceutical Products and Contact Materials supplies a much-needed, comprehensive resource to all those in pharmaceutical product or medical device development.
Peter Kleinebudde Continuous Manufacturing of Pharmaceuticals Peter Kleinebudde Continuous Manufacturing of Pharmaceuticals Новинка

Peter Kleinebudde Continuous Manufacturing of Pharmaceuticals

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A comprehensive look at existing technologies and processes for continuous manufacturing of pharmaceuticals As rising costs outpace new drug development, the pharmaceutical industry has come under intense pressure to improve the efficiency of its manufacturing processes. Continuous process manufacturing provides a proven solution. Among its many benefits are: minimized waste, energy consumption, and raw material use; the accelerated introduction of new drugs; the use of smaller production facilities with lower building and capital costs; the ability to monitor drug quality on a continuous basis; and enhanced process reliability and flexibility. Continuous Manufacturing of Pharmaceuticals prepares professionals to take advantage of that exciting new approach to improving drug manufacturing efficiency. This book covers key aspects of the continuous manufacturing of pharmaceuticals. The first part provides an overview of key chemical engineering principles and the current regulatory environment. The second covers existing technologies for manufacturing both small-molecule-based products and protein/peptide products. The following section is devoted to process analytical tools for continuously operating manufacturing environments. The final two sections treat the integration of several individual parts of processing into fully operating continuous process systems and summarize state-of-art approaches for innovative new manufacturing principles. Brings together the essential know-how for anyone working in drug manufacturing, as well as chemical, food, and pharmaceutical scientists working on continuous processing Covers chemical engineering principles, regulatory aspects, primary and secondary manufacturing, process analytical technology and quality-by-design Contains contributions from researchers in leading pharmaceutical companies, the FDA, and academic institutions Offers an extremely well-informed look at the most promising future approaches to continuous manufacturing of innovative pharmaceutical products Timely, comprehensive, and authoritative, Continuous Manufacturing of Pharmaceuticals is an important professional resource for researchers in industry and academe working in the fields of pharmaceuticals development and manufacturing.
Dennis Douroumis Hot-Melt Extrusion. Pharmaceutical Applications Dennis Douroumis Hot-Melt Extrusion. Pharmaceutical Applications Новинка

Dennis Douroumis Hot-Melt Extrusion. Pharmaceutical Applications

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Hot-melt extrusion (HME) – melting a substance and forcing it through an orifice under controlled conditions to form a new material – is an emerging processing technology in the pharmaceutical industry for the preparation of various dosage forms and drug delivery systems, for example granules and sustained release tablets. Hot-Melt Extrusion: Pharmaceutical Applications covers the main instrumentation, operation principles and theoretical background of HME. It then focuses on HME drug delivery systems, dosage forms and clinical studies (including pharmacokinetics and bioavailability) of HME products. Finally, the book includes some recent and novel HME applications, scale -up considerations and regulatory issues. Topics covered include: principles and die design of single screw extrusion twin screw extrusion techniques and practices in the laboratory and on production scale HME developments for the pharmaceutical industry solubility parameters for prediction of drug/polymer miscibility in HME formulations the influence of plasticizers in HME applications of polymethacrylate polymers in HME HME of ethylcellulose, hypromellose, and polyethylene oxide bioadhesion properties of polymeric films produced by HME taste masking using HME clinical studies, bioavailability and pharmacokinetics of HME products injection moulding and HME processing for pharmaceutical materials laminar dispersive & distributive mixing with dissolution and applications to HME technological considerations related to scale-up of HME processes devices and implant systems by HME an FDA perspective on HME product and process understanding improved process understanding and control of an HME process with near-infrared spectroscopy Hot-Melt Extrusion: Pharmaceutical Applications is an essential multidisciplinary guide to the emerging pharmaceutical uses of this processing technology for researchers in academia and industry working in drug formulation and delivery, pharmaceutical engineering and processing, and polymers and materials science. This is the first book from our brand new series Advances in Pharmaceutical Technology. Find out more about the series here.
Swantje Hartmann External Embeddedness of Subsidiaries Swantje Hartmann External Embeddedness of Subsidiaries Новинка

Swantje Hartmann External Embeddedness of Subsidiaries

In the research fields of International Business and International Management it is stated that product innovations are not only developed by headquarters (HQs) but also by foreign subsidiaries. Subsidiaries thereby apply the knowledge they obtain in inter-organizational business relationships with stakeholders like customers, suppliers, competitors, research institutions or governmental organizations. After being finished, product innovations are either exclusively employed by the creative subsidiaries or they are also transferred in intra-organizational business relationships to other units of the MNC, i. e. HQs or other subsidiaries.This book deals with both the product innovation process in foreign subsidiaries and the innovation transfer process to other units of the MNC. Using the example of the pharmaceutical industry it demonstrates which stakeholders affect the development of a product innovation. For the first time, stakeholders, business relationships and knowledge flows are analyzed at each stage of the product innovation process. The study proves that during the innovation process different stakeholders - other than the often analyzed customers and suppliers - play a crucial role for the foreign subsidiary. Above that, the book depicts the sophisticated structures and processes that MNCs in the pharmaceutical industry have established to transfer the newly created product innovations within their companies.The book addresses researchers and students in the fields...
David J. am Ende Chemical Engineering in the Pharmaceutical Industry. R&D to Manufacturing David J. am Ende Chemical Engineering in the Pharmaceutical Industry. R&D to Manufacturing Новинка

David J. am Ende Chemical Engineering in the Pharmaceutical Industry. R&D to Manufacturing

17314.22 руб. или Купить в рассрочку!
This book deals with various unique elements in the drug development process within chemical engineering science and pharmaceutical R&D. The book is intended to be used as a professional reference and potentially as a text book reference in pharmaceutical engineering and pharmaceutical sciences. Many of the experimental methods related to pharmaceutical process development are learned on the job. This book is intended to provide many of those important concepts that R&D Engineers and manufacturing Engineers should know and be familiar if they are going to be successful in the Pharmaceutical Industry. These include basic analytics for quantitation of reaction components– often skipped in ChE Reaction Engineering and kinetics books. In addition Chemical Engineering in the Pharmaceutical Industry introduces contemporary methods of data analysis for kinetic modeling and extends these concepts into Quality by Design strategies for regulatory filings. For the current professionals, in-silico process modeling tools that streamline experimental screening approaches is also new and presented here. Continuous flow processing, although mainstream for ChE, is unique in this context given the range of scales and the complex economics associated with transforming existing batch-plant capacity. The book will be split into four distinct yet related parts. These parts will address the fundamentals of analytical techniques for engineers, thermodynamic modeling, and finally provides an appendix with common engineering tools and examples of their applications.
Takayuki Shioiri Pharmaceutical Process Chemistry Takayuki Shioiri Pharmaceutical Process Chemistry Новинка

Takayuki Shioiri Pharmaceutical Process Chemistry

17140.02 руб. или Купить в рассрочку!
Covering the whole area of process chemistry in the pharmaceutical industry, this monograph provides the essential knowledge on the basic chemistry needed for future development and key industrial techniques, as well as morphology, engineering and regulatory compliances. Application-oriented and well structured, the authors include recent examples of excellent industrial production of active pharmaceutical ingredients.
Behnam Davani Pharmaceutical Analysis for Small Molecules Behnam Davani Pharmaceutical Analysis for Small Molecules Новинка

Behnam Davani Pharmaceutical Analysis for Small Molecules

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A comprehensive introduction for scientists engaged in new drug development, analysis, and approvals Each year the pharmaceutical industry worldwide recruits thousands of recent science graduates—especially chemistry, analytical chemistry, pharmacy, and pharmaceutical majors—into its ranks. However, because of their limited background in pharmaceutical analysis most of those new recruits find making the transition from academia to industry very difficult. Designed to assist both recent graduates, as well as experienced chemists or scientists with limited regulatory, compendial or pharmaceutical analysis background, make that transition, Pharmaceutical Analysis for Small Molecules is a concise, yet comprehensive introduction to the drug development process and analysis of chemically synthesized, small molecule drugs. It features contributions by distinguished experts in the field, including editor and author, Dr. Behnam Davani, an analytical chemist with decades of technical management and teaching experience in compendial, regulatory, and industry. This book provides an introduction to pharmaceutical analysis for small molecules (non-biologics) using commonly used techniques for drug characterization and performance tests. The driving force for industry to perform pharmaceutical analyses is submission of such data and supporting documents to regulatory bodies for drug approval in order to market their products. In addition, related required supporting studies including good laboratory/documentation practices including analytical instrument qualification are highlighted in this book. Topics covered include: Drug Approval Process and Regulatory Requirements (private standards) Pharmacopeias and Compendial Approval Process (public standards) Common methods in pharmaceutical analysis (typically compendial) Common Calculations for assays and impurities and other specific tests Analytical Method Validation, Verification, Transfer Specifications including how to handle out of specification (OOS) and out of trend (OOT) Impurities including organic, inorganic, residual solvents and elemental impurities Good Documentation Practices for regulatory environment Management of Analytical Laboratories Analytical Instrument Qualifications including IQ, OQ, PQ and VQ Due to global nature of pharmaceutical industry, other topics on both regulatory (ICH) and Compendial harmonization are also highlighted. Pharmaceutical Analysis for Small Molecules is a valuable working resource for scientists directly or indirectly involved with the drug development process, including analytical chemists, pharmaceutical scientists, pharmacists, and quality control/quality assurance professionals. It also is an excellent text/reference for graduate students in analytical chemistry, pharmacy, pharmaceutical and regulatory sciences.
James Lyng G. Emerging Technologies in Meat Processing. Production, Processing and Technology James Lyng G. Emerging Technologies in Meat Processing. Production, Processing and Technology Новинка

James Lyng G. Emerging Technologies in Meat Processing. Production, Processing and Technology

14969.2 руб. или Купить в рассрочку!
Meat is a global product, which is traded between regions, countries and continents. The onus is on producers, manufacturers, transporters and retailers to ensure that an ever-demanding consumer receives a top quality product that is free from contamination. With such a dynamic product and market place, new innovative ways to process, package and assess meat products are being developed. With ever increasing competition and tighter cost margins, industry has shown willingness to engage in seeking novel innovative ways of processing, packaging and assessing meat products while maintaining quality and safety attributes. This book provides a comprehensive overview on the application of novel processing techniques. It represents a standard reference book on novel processing, packaging and assessment methods of meat and meat products. It is part of the IFST Advances in Food Science book series.
Jaswal Isha, Kandal Nandita Indian Pharmaceutical Industry. Boon or Bane Jaswal Isha, Kandal Nandita Indian Pharmaceutical Industry. Boon or Bane Новинка

Jaswal Isha, Kandal Nandita Indian Pharmaceutical Industry. Boon or Bane

Health is an essential socio-economic asset which contributes to economic development in numerous ways like enhanced productivity, improved human capital etc. Sizable improvement in health outcomes are a prerequisite for a developing country like India to break out of its vicious circle of poverty. Indian pharmaceutical industry in turn plays a vital role in providing health care to billions of population in India and abroad. However, several malpractices and frauds in the midst of stiff market competition adversely affect the consumers. This paper thus aims at highlighting the issues concerning the Indian pharmaceutical industry and its undesirable impacts on consumers.
Philip Rowe Essential Statistics for the Pharmaceutical Sciences Philip Rowe Essential Statistics for the Pharmaceutical Sciences Новинка

Philip Rowe Essential Statistics for the Pharmaceutical Sciences

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Essential Statistics for the Pharmaceutical Sciences is targeted at all those involved in research in pharmacology, pharmacy or other areas of pharmaceutical science; everybody from undergraduate project students to experienced researchers should find the material they need. This book will guide all those who are not specialist statisticians in using sound statistical principles throughout the whole journey of a research project – designing the work, selecting appropriate statistical methodology and correctly interpreting the results. It deliberately avoids detailed calculation methodology. Its key features are friendliness and clarity. All methods are illustrated with realistic examples from within pharmaceutical science. This edition now includes expanded coverage of some of the topics included in the first edition and adds some new topics relevant to pharmaceutical research. a clear, accessible introduction to the key statistical techniques used within the pharmaceutical sciences all examples set in relevant pharmaceutical contexts. key points emphasised in summary boxes and warnings of potential abuses in ‘pirate boxes’. supplementary material – full data sets and detailed instructions for carrying out analyses using packages such as SPSS or Minitab – provided at www.ljmu.ac.uk/pbs/rowestats/ An invaluable introduction to statistics for any science student and an essential text for all those involved in pharmaceutical research at whatever level.
Yuriy Abramov A. Computational Pharmaceutical Solid State Chemistry Yuriy Abramov A. Computational Pharmaceutical Solid State Chemistry Новинка

Yuriy Abramov A. Computational Pharmaceutical Solid State Chemistry

11223.35 руб. или Купить в рассрочку!
This book is the first to combine computational material science and modeling of molecular solid states for pharmaceutical industry applications. • Provides descriptive and applied state-of-the-art computational approaches and workflows to guide pharmaceutical solid state chemistry experiments and to support/troubleshoot API solid state selection • Includes real industrial case examples related to application of modeling methods in problem solving • Useful as a supplementary reference/text for undergraduate, graduate and postgraduate students in computational chemistry, pharmaceutical and biotech sciences, and materials science
Christine Seymour Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture Christine Seymour Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture Новинка

Christine Seymour Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture

13098.05 руб. или Купить в рассрочку!
Covers a widespread view of Quality by Design (QbD) encompassing the many stages involved in the development of a new drug product. The book provides a broad view of Quality by Design (QbD) and shows how QbD concepts and analysis facilitate the development and manufacture of high quality products. QbD is seen as a framework for building process understanding, for implementing robust and effective manufacturing processes and provides the underpinnings for a science-based regulation of the pharmaceutical industry. Edited by the three renowned researchers in the field, Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture guides pharmaceutical engineers and scientists involved in product and process development, as well as teachers, on how to utilize QbD practices and applications effectively while complying with government regulations. The material is divided into three main sections: the first six chapters address the role of key technologies, including process modeling, process analytical technology, automated process control and statistical methodology in supporting QbD and establishing the associated design space. The second section consisting of seven chapters present a range of thoroughly developed case studies in which the tools and methodologies discussed in the first section are used to support specific drug substance and drug-product QbD related developments. The last section discussed the needs for integrated tools and reviews the status of information technology tools available for systematic data and knowledge management to support QbD and related activities. Highlights Demonstrates Quality by Design (QbD) concepts through concrete detailed industrial case studies involving of the use of best practices and assessment of regulatory implications Chapters are devoted to applications of QbD methodology in three main processing sectors—drug substance process development, oral drug product manufacture, parenteral product processing, and solid-liquid processing Reviews the spectrum of process model types and their relevance, the range of state-of-the-art real-time monitoring tools and chemometrics, and alternative automatic process control strategies and methods for both batch and continuous processes The role of the design space is demonstrated through specific examples and the importance of understanding the risk management aspects of design space definition is highlighted Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture is an ideal book for practitioners, researchers, and graduate students involved in the development, research, or studying of a new drug and its associated manufacturing process.
Gabriella Baki Introduction to Cosmetic Formulation and Technology Gabriella Baki Introduction to Cosmetic Formulation and Technology Новинка

Gabriella Baki Introduction to Cosmetic Formulation and Technology

11226.9 руб. или Купить в рассрочку!
Designed as an educational and training text, this book provides a clear and easily understandable review of cosmetics and over the counter (OTC) drug-cosmetic products. The text features learning objectives, key concepts, and key terms at the beginning and review questions and glossary of terms at the end of each chapter section. • Overviews functions, product design, formulation and development, and quality control of cosmetic ingredients • Discusses physiological, pharmaceutical, and formulation knowledge of decorative care products • Reviews basic terms and definitions used in the cosmetic industry and provides an overview of the regulatory environment in the US • Includes learning objectives, key concepts, and key terms at the beginning and review questions and glossary of terms at the end of each chapter section • Has PowerPoint slides as ancillaries, downloadable from the book's wiley.com page, for adopting professors
Storey Richard A. Solid State Characterization of Pharmaceuticals Storey Richard A. Solid State Characterization of Pharmaceuticals Новинка

Storey Richard A. Solid State Characterization of Pharmaceuticals

18754.87 руб. или Купить в рассрочку!
The field of solid state characterization is central to the pharmaceutical industry, as drug products are, in an overwhelming number of cases, produced as solid materials. Selection of the optimum solid form is a critical aspect of the development of pharmaceutical compounds, due to their ability to exist in more than one form or crystal structure (polymorphism). These polymorphs exhibit different physical properties which can affect their biopharmaceutical properties. This book provides an up-to-date review of the current techniques used to characterize pharmaceutical solids. Ensuring balanced, practical coverage with industrial relevance, it covers a range of key applications in the field. The following topics are included: Physical properties and processes Thermodynamics Intellectual guidance X-ray diffraction Spectroscopy Microscopy Particle sizing Mechanical properties Vapour sorption Thermal analysis & Calorimetry Polymorph prediction Form selection
Nicolas Abatzoglou Pharmaceutical Blending and Mixing Nicolas Abatzoglou Pharmaceutical Blending and Mixing Новинка

Nicolas Abatzoglou Pharmaceutical Blending and Mixing

12270.77 руб. или Купить в рассрочку!
Written in four parts, this book provides a dedicated and in-depth reference for blending within the pharmaceutical manufacturing industry. It links the science of blending with regulatory requirements associated with pharmaceutical manufacture. The contributors are a combination of leading academic and industrial experts, who provide an informed and industrially relevant perspective of the topic. This is an essential book for the pharmaceutical manufacturing industry, and related academic researchers in pharmaceutical science and chemical and mechanical engineering.
Gerhard Wagner Product Design and Engineering. Formulation of Gels and Pastes Gerhard Wagner Product Design and Engineering. Formulation of Gels and Pastes Новинка

Gerhard Wagner Product Design and Engineering. Formulation of Gels and Pastes

13996.35 руб. или Купить в рассрочку!
Covering the whole value chain – from product requirements and properties via process technologies and equipment to real-world applications – this reference represents a comprehensive overview of the topic. The editors and majority of the authors are members of the European Federation of Chemical Engineering, with backgrounds from academia as well as industry. Therefore, this multifaceted area is highlighted from different angles: essential physico-chemical background, latest measurement and prediction techniques, and numerous applications from cosmetic up to food industry. Recommended reading for process, pharma and chemical engineers, chemists in industry, and those working in the pharmaceutical, food, cosmetics, dyes and pigments industries.
Ekins Sean Pharmaceutical Data Mining. Approaches and Applications for Drug Discovery Ekins Sean Pharmaceutical Data Mining. Approaches and Applications for Drug Discovery Новинка

Ekins Sean Pharmaceutical Data Mining. Approaches and Applications for Drug Discovery

12099.92 руб. или Купить в рассрочку!
Leading experts illustrate how sophisticated computational data mining techniques can impact contemporary drug discovery and development In the era of post-genomic drug development, extracting and applying knowledge from chemical, biological, and clinical data is one of the greatest challenges facing the pharmaceutical industry. Pharmaceutical Data Mining brings together contributions from leading academic and industrial scientists, who address both the implementation of new data mining technologies and application issues in the industry. This accessible, comprehensive collection discusses important theoretical and practical aspects of pharmaceutical data mining, focusing on diverse approaches for drug discovery—including chemogenomics, toxicogenomics, and individual drug response prediction. The five main sections of this volume cover: A general overview of the discipline, from its foundations to contemporary industrial applications Chemoinformatics-based applications Bioinformatics-based applications Data mining methods in clinical development Data mining algorithms, technologies, and software tools, with emphasis on advanced algorithms and software that are currently used in the industry or represent promising approaches In one concentrated reference, Pharmaceutical Data Mining reveals the role and possibilities of these sophisticated techniques in contemporary drug discovery and development. It is ideal for graduate-level courses covering pharmaceutical science, computational chemistry, and bioinformatics. In addition, it provides insight to pharmaceutical scientists, principal investigators, principal scientists, research directors, and all scientists working in the field of drug discovery and development and associated industries.
Oliver Gassmann Value Creation in the Pharmaceutical Industry. The Critical Path to Innovation Oliver Gassmann Value Creation in the Pharmaceutical Industry. The Critical Path to Innovation Новинка

Oliver Gassmann Value Creation in the Pharmaceutical Industry. The Critical Path to Innovation

8897.73 руб. или Купить в рассрочку!
This practical guide for advanced students and decision-makers in the pharma and biotech industry presents key success factors in R&D along with value creators in pharmaceutical innovation. A team of editors and authors with extensive experience in academia and industry and at some of the most prestigious business schools in Europe discusses in detail the innovation process in pharma as well as common and new research and innovation strategies. In doing so, they cover collaboration and partnerships, open innovation, biopharmaceuticals, translational medicine, good manufacturing practice, regulatory affairs, and portfolio management. Each chapter covers controversial aspects of recent developments in the pharmaceutical industry, with the aim of stimulating productive debates on the most effective and efficient innovation processes. A must-have for young professionals and MBA students preparing to enter R&D in pharma or biotech as well as for students on a combined BA/biomedical and natural sciences program.
Pete Harpum Portfolio, Program, and Project Management in the Pharmaceutical and Biotechnology Industries Pete Harpum Portfolio, Program, and Project Management in the Pharmaceutical and Biotechnology Industries Новинка

Pete Harpum Portfolio, Program, and Project Management in the Pharmaceutical and Biotechnology Industries

9679.93 руб. или Купить в рассрочку!
This book describes the way that pharmaceutical projects and programs are currently managed, and offers views from many highly experienced practitioners from within the industry on future directions for drug program management. The book integrates portfolio, program, and project management processes as fundamental for effective and efficient drug product development. Contributing expert authors provide their view of how the projectization approach can be taken forward by the drug industry over the coming years.
Hamid Mollah Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing Hamid Mollah Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing Новинка

Hamid Mollah Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing

10254.05 руб. или Купить в рассрочку!
Sets forth tested and proven risk management practices in drug manufacturing Risk management is essential for safe and efficient pharmaceutical and biopharmaceutical manufacturing, control, and distribution. With this book as their guide, readers involved in all facets of drug manufacturing have a single, expertly written, and organized resource to guide them through all facets of risk management and analysis. It sets forth a solid foundation in risk management concepts and then explains how these concepts are applied to drug manufacturing. Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing features contributions from leading international experts in risk management and drug manufacturing. These contributions reflect the latest research, practices, and industry standards as well as the authors' firsthand experience. Readers can turn to the book for: Basic foundation of risk management principles, practices, and applications Tested and proven tools and methods for managing risk in pharmaceutical and biopharmaceutical product manufacturing processes Recent FDA guidelines, EU regulations, and international standards governing the application of risk management to drug manufacturing Case studies and detailed examples demonstrating the use and results of applying risk management principles to drug product manufacturing Bibliography and extensive references leading to the literature and helpful resources in the field With its unique focus on the application of risk management to biopharmaceutical and pharmaceutical manufacturing, this book is an essential resource for pharmaceutical and process engineers as well as safety and compliance professionals involved in drug manufacturing.
Jacqueline Beckley H. Accelerating New Food Product Design and Development Jacqueline Beckley H. Accelerating New Food Product Design and Development Новинка

Jacqueline Beckley H. Accelerating New Food Product Design and Development

14969.2 руб. или Купить в рассрочку!
Written primarily for directors and managers of food design and development, food scientists, technologists, and product developers, this book explains all the necessary information in order to help meet the increasing demands for innovation in an industry that is providing fewer resources. This updated edition, by a group of seasoned food industry business professionals and academics, provides a real-world perspective of what is occurring in the food industry right now, offers strategic frameworks for problem solving and R&D strategies, and presents methods needed to accelerate and optimize new product development. Accelerating New Food Product Design and Development, Second Edition features five brand new chapters covering all the changes that have occurred within the last decade: A Flavor Supplier Perspective, An Ingredient Supplier Perspective, Applying Processes that Accelerate New Product Development, Looking at How the University Prepares Someone for a Career in Food, and Innovative Packaging and Its Impact on Accelerated Product Development. Offers new perspectives on what really goes on during the development process Includes updated chapters fully describing the changes that have occurred in the food industry, both from a developer’s point of view as well as the consumer requirements Features a completely rewritten chapter covering the importance of packaging which is enhanced through 3D printing All of this against the impact on speed to market Filled with unique viewpoints of the business from those who really know and a plethora of new information, Accelerating New Food Product Design and Development, Second Edition will be of great interest to all professionals engaged in new food product design and development.
Amalia Conte Advances in Dairy Products Amalia Conte Advances in Dairy Products Новинка

Amalia Conte Advances in Dairy Products

13098.05 руб. или Купить в рассрочку!
Advances in Dairy Product Science & Technology offers a comprehensive review of the most innovative scientific knowledge in the dairy food sector. Edited and authored by noted experts from academic and industry backgrounds, this book shows how the knowledge from strategic and applied research can be utilized by the commercial innovation of dairy product manufacture and distribution. Topics explored include recent advances in the dairy sector, such as raw materials and milk processing, environmental impact, economic concerns and consumer acceptance. The book includes various emerging technologies applied to milk and starter cultures sources, strategic options for their use, their characterization, requirements, starter growth and delivery and other ingredients used in the dairy industry. The text also outlines a framework on consumer behavior that can help to determine quality perception of food products and decision-making. Consumer insight techniques can help support the identification of market opportunities and represent a useful mean to test product prototypes before final launch. This comprehensive resource: Assesses the most innovative scientific knowledge in the dairy food sector Reviews the latest technological developments relevant for dairy companies Covers new advances across a range of topics including raw material processing, starter cultures for fermented products, processing and packaging Examines consumer research innovations in the dairy industry Written for dairy scientists, other dairy industry professionals, government agencies, educators and students, Advances in Dairy Product Science & Technology includes vital information on the most up-to-date and scientifically sound research in the field.
Jurgen Bajorath Chemoinformatics for Drug Discovery Jurgen Bajorath Chemoinformatics for Drug Discovery Новинка

Jurgen Bajorath Chemoinformatics for Drug Discovery

9655.42 руб. или Купить в рассрочку!
Chemoinformatics strategies to improve drug discovery results With contributions from leading researchers in academia and the pharmaceutical industry as well as experts from the software industry, this book explains how chemoinformatics enhances drug discovery and pharmaceutical research efforts, describing what works and what doesn't. Strong emphasis is put on tested and proven practical applications, with plenty of case studies detailing the development and implementation of chemoinformatics methods to support successful drug discovery efforts. Many of these case studies depict groundbreaking collaborations between academia and the pharmaceutical industry. Chemoinformatics for Drug Discovery is logically organized, offering readers a solid base in methods and models and advancing to drug discovery applications and the design of chemoinformatics infrastructures. The book features 15 chapters, including: What are our models really telling us? A practical tutorial on avoiding common mistakes when building predictive models Exploration of structure-activity relationships and transfer of key elements in lead optimization Collaborations between academia and pharma Applications of chemoinformatics in pharmaceutical research—experiences at large international pharmaceutical companies Lessons learned from 30 years of developing successful integrated chemoinformatic systems Throughout the book, the authors present chemoinformatics strategies and methods that have been proven to work in pharmaceutical research, offering insights culled from their own investigations. Each chapter is extensively referenced with citations to original research reports and reviews. Integrating chemistry, computer science, and drug discovery, Chemoinformatics for Drug Discovery encapsulates the field as it stands today and opens the door to further advances.
Sandy Weinberg Cost-Contained Regulatory Compliance. For the Pharmaceutical, Biologics, and Medical Device Industries Sandy Weinberg Cost-Contained Regulatory Compliance. For the Pharmaceutical, Biologics, and Medical Device Industries Новинка

Sandy Weinberg Cost-Contained Regulatory Compliance. For the Pharmaceutical, Biologics, and Medical Device Industries

8768.66 руб. или Купить в рассрочку!
This book guides the reader through FDA regulation guidelines and outlines a comprehensive strategy for cost reduction in regulatory affairs and compliance. This book explains six strategies to cost-effectively comply with FDA regulations while maintaining product safety and improving public access through cost controls. It provides useful and practical guidance through industry case studies from pharmaceutical, biotech, and medical device industries.
Hugo Kubinyi Chemokine Receptors as Drug Targets Hugo Kubinyi Chemokine Receptors as Drug Targets Новинка

Hugo Kubinyi Chemokine Receptors as Drug Targets

15493.27 руб. или Купить в рассрочку!
Chemokines are hormone-like signaling molecules secreted by cells to signal infection and guide the immune response. Following a decade of basic chemokine research, the pharmaceutical industry has now begun to exploit this crucial signaling pathway for the development of innovative drugs against AIDS, cancer, neural and autoimmune diseases. Here is the first reference focusing on these novel drug development opportunities. Opening with a general introduction on chemokine function and chemokine receptor biology, the second part covers the known implications of these signaling molecules in human diseases, such as cancer, neural disorders, and viral infection, including AIDS. The third part systematically surveys current drug development efforts at targeting individual chemokine receptors, as well as other chemokine interaction partners, including up-to-date reports from the pharmaceutical industry.
Otilia M. Y. Koo Pharmaceutical Excipients. Properties, Functionality, and Applications in Research and Industry Otilia M. Y. Koo Pharmaceutical Excipients. Properties, Functionality, and Applications in Research and Industry Новинка

Otilia M. Y. Koo Pharmaceutical Excipients. Properties, Functionality, and Applications in Research and Industry

13098.05 руб. или Купить в рассрочку!
This book provides an overview of excipients, their functionalities in pharmaceutical dosage forms, regulation, and selection for pharmaceutical products formulation. It includes development, characterization methodology, applications, and up-to-date advances through the perspectives of excipients developers, users, and regulatory experts. Covers the sources, characterization, and harmonization of excipients: essential information for optimal excipients selection in pharmaceutical development Describes the physico-chemical properties and biological effects of excipients Discusses chemical classes, safety and toxicity, and formulation Addresses recent efforts in the standardization and harmonization of excipients
Innovation in the Pharmaceutical Industry: The Process of Drug Discovery and Development Innovation in the Pharmaceutical Industry: The Process of Drug Discovery and Development Новинка

Innovation in the Pharmaceutical Industry: The Process of Drug Discovery and Development

Book DescriptionInnovation in the Pharmaceutical Industry traces the discovery and development of drugs in Japan and the UK both historically and sociologically. It includes sixteen case studies of major pharmaceutical developments in the twentieth century, encompassing, among others, beta-blockers, beta-stimulants, inhaled steroids and histamine H2-antagonists. The book illustrates that the four stages of drug development - namely compound, application, organizational authorization and market - are interactively shaped by heterogeneous actors and institutions. The book also identifies three different types of pharmaceutical development - paradigmatic innovation, application innovation and modification-based innovation, all with distinguishable features in the drug development process. Finally, several historical, structural and cultural factors influencing the shaping of medicines are revealed by the comparison between British and Japanese drug innovation. Addressing a number of practical implications for the promotion of the pharmaceutical industry, this book will be of enormous interest to students, researchers and academics specializing in science and technology, and the management of technology and innovation. Practitioners, managers, and policy planners within the pharmaceutical industry will also deem this book invaluable.
Gary Prager Practical Pharmaceutical Engineering Gary Prager Practical Pharmaceutical Engineering Новинка

Gary Prager Practical Pharmaceutical Engineering

12704.91 руб. или Купить в рассрочку!
A practical guide to all key the elements of pharmaceuticals and biotech manufacturing and design Engineers working in the pharmaceutical and biotech industries are routinely called upon to handle operational issues outside of their fields of expertise. Traditionally the competencies required to fulfill those tasks were achieved piecemeal, through years of self-teaching and on-the-job experience—until now. Practical Pharmaceutical Engineering provides readers with the technical information and tools needed to deal with most common engineering issues that can arise in the course of day-to-day operations of pharmaceutical/biotech research and manufacturing. Engineers working in pharma/biotech wear many hats. They are involved in the conception, design, construction, and operation of research facilities and manufacturing plants, as well as the scale-up, manufacturing, packaging, and labeling processes. They have to implement FDA regulations, validation assurance, quality control, and Good Manufacturing Practices (GMP) compliance measures, and to maintain a high level of personal and environmental safety. This book provides readers from a range of engineering specialties with a detailed blueprint and the technical knowledge needed to tackle those critical responsibilities with confidence. At minimum, after reading this book, readers will have the knowledge needed to constructively participate in contractor/user briefings. Provides pharmaceutical industry professionals with an overview of how all the parts fit together and a level of expertise that can take years of on-the-job experience to acquire Addresses topics not covered in university courses but which are crucial to working effectively in the pharma/biotech industry Fills a gap in the literature, providing important information on pharmaceutical operation issues required for meeting regulatory guidelines, plant support design, and project engineering Covers the basics of HVAC systems, water systems, electric systems, reliability, maintainability, and quality assurance, relevant to pharmaceutical engineering Practical Pharmaceutical Engineering is an indispensable “tool of the trade” for chemical engineers, mechanical engineers, and pharmaceutical engineers employed by pharmaceutical and biotech companies, engineering firms, and consulting firms. It also is a must-read for engineering students, pharmacy students, chemistry students, and others considering a career in pharmaceuticals.
Gaisford Simon Essentials of Pharmaceutical Preformulation Gaisford Simon Essentials of Pharmaceutical Preformulation Новинка

Gaisford Simon Essentials of Pharmaceutical Preformulation

11721.79 руб. или Купить в рассрочку!
Essentials of Pharmaceutical Preformulation is a study guide which describes the basic principles of pharmaceutical physicochemical characterisation. Successful preformulation requires knowledge of fundamental molecular concepts (solubility, ionisation, partitioning, hygroscopicity and stability) and macroscopic properties (physical form, such as the crystalline and amorphous states, hydrates, solvates and co-crystals and powder properties), familiarity with the techniques used to measure them and appreciation of their effect on product performance, recognising that often there is a position of compromise to be reached between product stability and bioavailability. This text introduces the basic concepts and discusses their wider implication for pharmaceutical development, with reference to many case examples of current drugs and drug products. Special attention is given to the principles and best-practice of the analytical techniques that underpin preformulation (UV spectrophotometry, TLC, DSC, XRPD and HPLC). The material is presented in the typical order that would be followed when developing a medicine and maps onto the indicative pharmacy syllabus of the Royal Pharmaceutical Society of Great Britain Undergraduate-level pharmacy students and R&D / analytical scientists working in the pharmaceutical sector (with or without a pharmaceutical background) will find this text easy to follow with relevant pharmaceutical examples. Essential study guide for pharmacy and pharmaceutical science students Covers the pharmaceutical preformulation components of the Royal Pharmaceutical Society of Great Britain’s indicative syllabus Easy to follow text highlighted with relevant pharmaceutical examples Self-assessment assignments in a variety of formats Written by authors with both academic and industrial experience Companion website with further information to maximise learning
Gary Zatzman M. The Greening of Pharmaceutical Engineering, Practice, Analysis, and Methodology Gary Zatzman M. The Greening of Pharmaceutical Engineering, Practice, Analysis, and Methodology Новинка

Gary Zatzman M. The Greening of Pharmaceutical Engineering, Practice, Analysis, and Methodology

16841.06 руб. или Купить в рассрочку!
The pharmaceutical industry is one of the most important industries in the world, offering new medicines, vaccines, and cures to a global population. It is a massive industry, worthy of a deep and thorough examination of its processes and chemistry, with a view toward sustainability. The authors describe what is and isn't truly sustainable, offering a new approach and a new definition of the sustainability of pharmaceutical and chemical engineering and the science behind it. This is a cutting-edge work, aimed at engineers, scientists, researchers, chemists, and students.
Kirk Teska Patent Project Management Kirk Teska Patent Project Management Новинка

Kirk Teska Patent Project Management

This is a popular topic of critical importance to anyone planning to bring a new technical product to market. For all engineers and their managers concerned with product development, patent law and the patent process, but particularly early career engineers who need a basic introduction to the topic. Also a good refresher book for more experienced engineers.The author has eighteen years of intellectual property law experience. He has taught patent law and is a regular patent/IP columnist for MASS HIGH TECH and LAWYERS WEEKLY.
Satinder Ahuja Chiral Separation Methods for Pharmaceutical and Biotechnological Products Satinder Ahuja Chiral Separation Methods for Pharmaceutical and Biotechnological Products Новинка

Satinder Ahuja Chiral Separation Methods for Pharmaceutical and Biotechnological Products

11948.67 руб. или Купить в рассрочку!
Discusses chiral separations and offers guidance for selecting the optimum method for desired results Chiral separations represent the most intriguing and, by some measures, most difficultseparations of chemical compounds. This book provides researchers and students an under-standing of chiral separations and offers a convenient route to selecting the best separation method, saving considerable time and cost in product development. Considering chiral separations in the biotechnological and pharmaceutical industries, as well as for food applications, Dr. Ahuja provides insights into a broad range of topics. Opening with a broad overview of chiral separations, regulatory considerations in drug product development, and basic issues in method development, the book: Covers a variety of modern methods such as gas chromatography, high performance liquid chromatography, supercritical fluid chromatography, and capillary electrophoresis Deals with the impact of chirality on the biological activity of small and large molecules Provides detailed information on useful chiral stationary phases (CSPs) for HPLC Includes handy information on selection of an appropriate CSP, including mechanistic studies Offers strategies for fast method development with HPLC, SFC, and CE Discusses preparatory methods utilized in the pharmaceutical industry With in-depth discussions of the current state of the field as well as suggestions to assist future developments, Chiral Separation Methods for Pharmaceutical and Biotechnological Products is an essential text for laboratory investigators, managers, and regulators who are involved in chiral separations in the pharmaceutical industry, as well as students preparing for careers in these fields.
Stuart Walker Benefit-Risk Appraisal of Medicines. A systematic approach to decision-making Stuart Walker Benefit-Risk Appraisal of Medicines. A systematic approach to decision-making Новинка

Stuart Walker Benefit-Risk Appraisal of Medicines. A systematic approach to decision-making

9951.54 руб. или Купить в рассрочку!
Benefit-risk assessment is at the centre of the approval process for every new medicine. The ability to assess the risks of a new medicine accurately and to balance these against the benefits the medicine could bring is critical for every regulatory authority and pharmaceutical company. Despite this there are very few tried and tested evaluative models currently available. The authors of this book have developed a new, pioneering tool for the assessment of benefits and risks for new medicines in development. This model utilises a multi-criteria decision analysis which involves selecting, scoring and weighting key benefit and risk attributes and leads to an overall appraisal of benefits and risks of medicines. Benefit-Risk Appraisal of Medicines establishes the background and criteria required to assess benefit and risk in general and reviews the current practices by regulatory authorities and the pharmaceutical industry, including those models currently available. It outlines the development and evaluation of the authors’ new model and analyses the implications of its implementation. Describes an innovative, systematic model which leads to transparent and responsible benefit-risk decision making Contributes important ideas to the debate on benefit-risk appraisal Provides a future framework for benefit-risk appraisal of medicines Benefit-Risk Appraisal of Medicines covers the entire process from the discovery of new medicines to their marketing and is ideal for all those who work in the pharmaceutical industry and regulatory authorities,, as well as post-graduate students of pharmaceutical medicine and clinical pharmacology.
Daniel Norwood L. Leachables and Extractables Handbook. Safety Evaluation, Qualification, and Best Practices Applied to Inhalation Drug Products Daniel Norwood L. Leachables and Extractables Handbook. Safety Evaluation, Qualification, and Best Practices Applied to Inhalation Drug Products Новинка

Daniel Norwood L. Leachables and Extractables Handbook. Safety Evaluation, Qualification, and Best Practices Applied to Inhalation Drug Products

10852.67 руб. или Купить в рассрочку!
A practical and science-based approach for addressing toxicological concerns related to leachables and extractables associated with inhalation drug products Packaging and device components of Orally Inhaled and Nasal Drug Products (OINDP)—such as metered dose inhalers, dry powder inhalers, and nasal sprays—pose potential safety risks from leachables and extractables, chemicals that can be released or migrate from these components into the drug product. Addressing the concepts, background, historical use, and development of safety thresholds and their utility for qualifying leachables and extractables in OINDP, the Leachables and Extractables Handbook takes a practical approach to familiarize readers with the recent recommendations for safety and risk assessment established through a joint effort of scientists from the FDA, academia, and industry. Coverage includes best practices for the chemical evaluation and management of leachables and extractables throughout the pharmaceutical product life cycle, as well as: Guidance for pharmaceutical professionals to qualify and risk-assess container closure system leachables and extractables in drug products Principles for defining toxicological safety thresholds that are applicable to OINDP and potentially applicable to other drug products Regulatory perspectives, along with an appendix of key terms and definitions, case studies, and sample protocols Analytical chemists, packaging and device engineers, formulation development scientists, component suppliers, regulatory affairs specialists, and toxicologists will all benefit from the wealth of information offered in this important text.
Elisabeth Felice Nehls Management Consultancy Elisabeth Felice Nehls Management Consultancy Новинка

Elisabeth Felice Nehls Management Consultancy

Research Paper (undergraduate) from the year 2010 in the subject Business economics - Business Management, Corporate Governance, grade: 1, Anglia Ruskin University, course: Management Consultancy Skills, language: English, abstract: Kingsholm Polymer Systems (KPS), a tape producing company, is located in the UK. It consists of three different sites: the paper masking tape faculty, a pvc tape producing faculty, and a cable jointing faculty. For KPS is in the producing and processing industry, the company acts as supplier to main customers such as electronic wholesalers, electronic cable manufacturers, do-it-yourself stores (DIY), and the automotive industry. 450 members of staff are currently employed at KPS. The challenge KPS has to approach is to bring a new product, the so called Haltadon, to market. By doing so, KPS seeks to achieve a better market position, increase sales, enhance market share and better return on investments (RoI). To cut it short: great expectations concerning improved profitability and reduced costs focus on the desired product launch, an undertaking coming along with certain defiance:• KPS does have a numerous amount of technical experts but the products do not always meet customer`s expectations.• KPS does have sales and finance employees but to analyze which clients and products bring value to the company has not been possible yet• Some of their products are more innovative than those of rivals but because KPSlacks patent protection, innovations soo...
Andreas Cmolik Threats and Opportunities for European Pharmaceutical Wholesalers in a Changing Healthcare Environment Andreas Cmolik Threats and Opportunities for European Pharmaceutical Wholesalers in a Changing Healthcare Environment Новинка

Andreas Cmolik Threats and Opportunities for European Pharmaceutical Wholesalers in a Changing Healthcare Environment

The aim of this book is to identify the major drivers of change within the European healthcare systems and to evaluate risks and opportunities confronting pharmaceutical full-line wholesalers. These businesses are the most important link between pharmaceutical manufacturing and the point of sale; providing one-stop-shopping for healthcare professionals across Europe.While on the one hand European governments are interested to ensure broad access to healthcare provision for the general public with a high level of quality, they are on the other hand concerned with limiting cost increases and with the need to cap healthcare spending.In addition, the pharmaceutical industry faces a strong need to cut costs by outsourcing non-core activities and establishing new routes to the customer, often bypassing the established supply chain.Changing healthcare environments across Europe ask for new strategies of pharmaceutical wholesalers to be fit for the future. This book deals with the advantages that can be derived from the changing landscape of healthcare provision.Aging populations, markets in transition, outsourcing activities of manufacturers and legal changes provide the potential to turn threats into opportunities and further develop the business model of pharmaceutical wholesaling. Even with profound structural changes in healthcare systems, pharmaceutical wholesalers are provided with significant potential to remain a vital part of the pharmaceutical supply chain and to prosper i...
Dalia Yablon G. Scanning Probe Microscopy for Industrial Applications. Nanomechanical Characterization Dalia Yablon G. Scanning Probe Microscopy for Industrial Applications. Nanomechanical Characterization Новинка

Dalia Yablon G. Scanning Probe Microscopy for Industrial Applications. Nanomechanical Characterization

9954.38 руб. или Купить в рассрочку!
Describes new state-of-the-science tools and their contribution to industrial R&D With contributions from leading international experts in the field, this book explains how scanning probe microscopy is used in industry, resulting in improved product formulation, enhanced processes, better quality control and assurance, and new business opportunities. Readers will learn about the use of scanning probe microscopy to support R&D efforts in the semiconductor, chemical, personal care product, biomaterial, pharmaceutical, and food science industries, among others. Scanning Probe Microscopy for Industrial Applications emphasizes nanomechanical characterization using scanning probe microscopy. The first half of the book is dedicated to a general overview of nanomechanical characterization methods, offering a complete practical tutorial for readers who are new to the topic. Several chapters include worked examples of useful calculations such as using Hertz mechanics with and without adhesion to model a contact, step-by-step instructions for simulations to guide cantilever selection for an experiment, and data analysis procedures for dynamic contact experiments. The second half of the book describes applications of nanomechanical characterization in industry, including: New formulation development for pharmaceuticals Measurement of critical dimensions and thin dielectric films in the semiconductor industry Effect of humidity and temperature on biomaterials Characterization of polymer blends to guide product formulation in the chemicals sector Unraveling links between food structure and function in the food industry Contributions are based on the authors' thorough review of the current literature as well as their own firsthand experience applying scanning probe microscopy to solve industrial R&D problems. By explaining the fundamentals before advancing to applications, Scanning Probe Microscopy for Industrial Applications offers a complete treatise that is accessible to both novices and professionals. All readers will discover how to apply scanning probe microscopy to build and enhance their R&D efforts.
Helmut Traitler The Food Industry Innovation School. How to Drive Innovation through Complex Organizations Helmut Traitler The Food Industry Innovation School. How to Drive Innovation through Complex Organizations Новинка

Helmut Traitler The Food Industry Innovation School. How to Drive Innovation through Complex Organizations

7481.05 руб. или Купить в рассрочку!
Innovation and new product development are increasingly perceived as drivers of profits in the food industry. Companies are dedicating a large amount of resources to these areas and it is crucial that individuals understand how to be part of this new strategy. Food Industry Innovation School focuses on key skills needed to drive new ideas from initial concepts through to successful products on the shelf. The author argues that any individual can learn how to lead innovation within complex organizations utilizing companies? commercial and financial resources. The book focuses on the impact of single individuals on company successes. Case studies from the marketplace provide valuable examples of accomplishments and failures. Product development involves a plethora of activities such as R&D,innovation, engineering, packaging and design, manufacturing,logistics and supply chain management, as well as marketing, sales and finance, and the book addresses all these crucial functions undertaken by food companies and manufacturers of other packaged consumer goods. The learning principles and examples (based on the author's personal experience) are valid in many fast-moving consumer goods organizations and so the principles, best practices and solutions offered in the 12 chapters are relevant to a wide audience in the food industry and beyond, including those working in household products, retail, the automotive industry, computers and IT, furniture, and even media and publishing. Read more: http://www.innovationschool.co/
Mennen, Abayomi, Jian Mergers and Acquisitions in the Global Pharmaceutical Industry Mennen, Abayomi, Jian Mergers and Acquisitions in the Global Pharmaceutical Industry Новинка

Mennen, Abayomi, Jian Mergers and Acquisitions in the Global Pharmaceutical Industry

Project Report from the year 2006 in the subject Communications - Public Relations, Advertising, Marketing, Social Media, grade: 65 % - B, University of Sunderland, course: Global Corporate Strategy, language: English, abstract: Mergers and acquisitions are of major importance in the pharmaceutical industry. In order to evaluate the dynamics of this particular industry, this paper critically evaluates the pre- and post- merger situation of GlaxoSmithKline concerning its ready-access to markets, know-how and management capability. Furthermore, strengths and weaknesses and merger's outcomes will be outlined. Critical push and pull factors affecting M&A activity in North America will be analysed, using Pfizer and Pharmacia as an example. In addition, general reasons for M&A failure in the pharmaceutical industry will be illustrated focussing on the M&A activity of GlaxoSmithKline. Finally, using two global pharmaceutical players (GSK and Astrazeneca), the merits and demerits of the McKinsey's five step programme will be discussed.
Dawn Drake A Profile of the Farm Machinery Industry. Helping Farmers Feed the World Dawn Drake A Profile of the Farm Machinery Industry. Helping Farmers Feed the World Новинка

Dawn Drake A Profile of the Farm Machinery Industry. Helping Farmers Feed the World

The farm machinery industry, though dominated by three large companies, is a complex sector of the global manufacturing economy that encompasses many smaller manufacturers as well. While contributing a small percentage to gross world product, it is vitally important to another key sector of the economy agriculture. Consequently, the recent rise in global crop prices has allowed the industry to be more resilient than other mature manufacturing sectors, like automobiles. The proposed book will provide a concise but comprehensive look at the farm machinery industry: its history, organization, competitors, and the challenges and opportunities the industry faces as a result of regulations, globalization and outside market forces. This will be done as a means of understanding a crucial building block to the success of agriculture's ability to feed the expanding world population.
Peter Nash Effective Product Control. Controlling for Trading Desks Peter Nash Effective Product Control. Controlling for Trading Desks Новинка

Peter Nash Effective Product Control. Controlling for Trading Desks

5039.55 руб. или Купить в рассрочку!
Improve the Effectiveness of your Product Control Function Effective Product Control is a detailed how-to guide covering everything you need to know about the function. Considered essential reading for: New controllers entering the profession Auditors and regulators reviewing product control Established controllers wanting a refresher on the latest skills and core controls within the industry. Encompassing both a technical skills primer and key insights into core controls used to mit­igate major risks emanating from trading desks, you will get expert advice on practical topics such as: The key IFRS and U.S. GAAP accounting standards for a trading desk How to approach the pricing of a financial instrument Market risk and how is it quantified The controls necessary for a trading desk Rogue trading and how it can be detected Valuation adjustments and why they are necessary How the prices used to value a trading portfolio are independently verified The financial accounting entries used to record financial instruments in the balance sheet and profit & loss statement Financial reporting and how the results of a trading desk are presented How a new financial product can be introduced in a controlled manner Complete with a wealth of insightful graphs, illustrations and real-world examples to enliven the covered material, the dependable answers you need are in Effective Product Control.
Eric Longino Sales Management Control, Territory Design, Sales Force Performance, and Sales Organizational Effectiveness in the Pharmaceutical Industry Eric Longino Sales Management Control, Territory Design, Sales Force Performance, and Sales Organizational Effectiveness in the Pharmaceutical Industry Новинка

Eric Longino Sales Management Control, Territory Design, Sales Force Performance, and Sales Organizational Effectiveness in the Pharmaceutical Industry

Limited research exists about the determinants of sales organization effectiveness in pharmaceutical sales organizations. To fill this void, sales management control, sales territory design, and sales force performance are conceptualized as antecedents to sales organization effectiveness in pharmaceutical sales organizations. The results of the structural equation model tested suggested that pharmaceutical sales representatives perform better and are more effective when they are satisfied with sales territory design because of its significant relationship with sales force behavioral performance. The present study suggests sales force behavioral performance leads to sales organization effectiveness through its significant relationship to sales force outcome performance. These findings are somewhat different to those from similar studies in other industries, and identify some important implications for sales leaders in the pharmaceutical industry as well as suggesting a number of important research directions.
Robin Harris K. NMR in Pharmaceutical Science Robin Harris K. NMR in Pharmaceutical Science Новинка

Robin Harris K. NMR in Pharmaceutical Science

10225.64 руб. или Купить в рассрочку!
NMR in Pharmaceutical Sciences is intended to be a comprehensive source of information for the many individuals that utilize MR in studies of relevance to the pharmaceutical sector. The book is intended to educate and inform those who develop and apply MR approaches within the wider pharmaceutical environment, emphasizing the toolbox that is available to spectroscopists and radiologists. This book is structured on the key processes in drug discovery, development and manufacture, but underpinned by an understanding of fundamental NMR principles and the unique contribution that NMR (including MRI) can provide. After an introductory chapter, which constitutes an overview, the content is organised into five sections. The first section is on the basics of NMR theory and relevant experimental methods. The rest follow a sequence based on the chronology of drug discovery and development, firstly 'Idea to Lead' then 'Lead to Drug Candidate', followed by 'Clinical Development', and finally 'Drug Manufacture'. The thirty one chapters cover a vast range of topics from analytical chemistry, including aspects involved in regulatory matters and in the prevention of fraud, to clinical imaging studies. Whilst this comprehensive volume will be essential reading for many scientists based in pharmaceutical and related industries, it should also be of considerable value to a much wider range of academic scientists whose research is related to the various aspects of pharmaceutical R&D; for them it will supply vital understanding of pharmaceutical industrial concerns and the basis of key decision making processes. About eMagRes Handbooks eMagRes (formerly the Encyclopedia of Magnetic Resonance) publishes a wide range of online articles on all aspects of magnetic resonance in physics, chemistry, biology and medicine. The existence of this large number of articles, written by experts in various fields, is enabling the publication of a series of eMagRes Handbooks on specific areas of NMR and MRI. The chapters of each of these handbooks will comprise a carefully chosen selection of eMagRes articles. In consultation with the eMagRes Editorial Board, the eMagRes handbooks are coherently planned in advance by specially-selected Editors, and new articles are written to give appropriate complete coverage. The handbooks are intended to be of value and interest to research students, postdoctoral fellows and other researchers learning about the scientific area in question and undertaking relevant experiments, whether in academia or industry. Have the content of this handbook and the complete content of eMagRes at your fingertips! Visit: www.wileyonlinelibrary.com/ref/eMagRes
Kevin Harrington, Daniel Priestley Key Person of Influence. The Five-Step Method to Become One of the Most Highly Valued and Highly Paid People in Your Industry Kevin Harrington, Daniel Priestley Key Person of Influence. The Five-Step Method to Become One of the Most Highly Valued and Highly Paid People in Your Industry Новинка

Kevin Harrington, Daniel Priestley Key Person of Influence. The Five-Step Method to Become One of the Most Highly Valued and Highly Paid People in Your Industry

Every industry revolves around Key People of Influence.Their names come up in conversation. They attract opportunity. They earn more money. Many people think it takes decades of hard work, academic qualifications and a generous measure of good luck to become a Key Person of Influence.This book shows that there is a strategy for fast-tracking your way to the inner circle of the industry you love. Your ability to succeed depends on your ability to influence. Start now by reading this book.This book is your invitation to the inner circle of your industry.
Michael Schäfer The importance of customer relationship management in the automotive supply industry Michael Schäfer The importance of customer relationship management in the automotive supply industry Новинка

Michael Schäfer The importance of customer relationship management in the automotive supply industry

Master's Thesis from the year 2006 in the subject Business economics - Marketing, Corporate Communication, CRM, Market Research, Social Media, grade: B-, University of Leicester (Management Center), 38 entries in the bibliography, language: English, abstract: The purpose of this dissertation is to investigate the importance of CRM in a specific industry for a specific company. More precisely, this work will explore the automotive supplier industry; and within that industry, the company Y will be analysed, discussed and explored. Y is a supplier of aluminium tubes and aluminium profiles to the global automotive industry. The research will encompass several key areas in an effort to present a multi-perspective work, including best practices, an overview of CRM, and key factors of success as well as an automotive industry survey that the author administered, documented and integrated into this dissertation to add an element from the real business world to the research.First, a broad overview of relevant CRM theories and their meaning will be presented in order to set the stage for a discussion of Y as a specific competitor in the automotive supplier industry and to facilitate realistic and effective comparison and contrast between industry trends and the chosen company in particular.Following the CRM theory overview, differences between business-to-business and business-to-consumer markets will be differentiated for a complete understanding of these two distinct segments of ...
Michael Lang Design of a Portfolio Management System for Software Line Development. Merging the Gap between Software Project and Product Management Michael Lang Design of a Portfolio Management System for Software Line Development. Merging the Gap between Software Project and Product Management Новинка

Michael Lang Design of a Portfolio Management System for Software Line Development. Merging the Gap between Software Project and Product Management

Tracy (1995, p. 19) emphasises in his book that in the twenty-first century, tomorrow will be more different from today than in the past. Therefore today's corporations get to stay innovative, reinvent themselves continuously and have to design new business. In contrast to that, software mastery becomes more than ever the key factor for business success (Northrop, 2008, p. 12). In the twenty-first century, software pervades every sector and has become the bottom line for many organisations. Therefore, reusability plays a growing role for every business in today's rapid changing world (Strahringer, 2003, p. 5). Thus, new paradigms in software engineering are focusing on the reutilisation and modularisation of software solutions. One innovative and growing concept since 2003 is software line development which has its origin in the automotive and fashion industry (Strahringer, 2003, p. 5). The key benefit of software line development is the covering of a wide field of application with minimal extra costs by reuse of a common software platform. In reference to Ebert & Smouts (2003, p. 29) the most publications in the field of software lines deal with configuration and change management. Whereas the integration of software line development into enterprises' product portfolios has been till now widely neglected. In contrast to that Jeffery & Leliveld (2004) points out that the failure or success of software lines highly depends in particular on their level of in...
Donald S. Rimai Patent Engineering. A Guide to Building a Valuable Patent Portfolio and Controlling the Marketplace Donald S. Rimai Patent Engineering. A Guide to Building a Valuable Patent Portfolio and Controlling the Marketplace Новинка

Donald S. Rimai Patent Engineering. A Guide to Building a Valuable Patent Portfolio and Controlling the Marketplace

11226.9 руб. или Купить в рассрочку!
Patents are a vital asset in the modern business world. They allow patent holders to introduce new products in to a market while deterring other market players from simply copying innovative features without making comparable investments in research and development. In years past, a few patents may have provided adequate protection. That is no longer the case. In today's world, it is critical that innovative companies protect the features of their products that give them a competitive advantage with a family or portfolio of patents that are strategically generated to protect the market position of the patent holder. A patent portfolio that deters competitors from introducing competitive products in a timely manner can be worth billions of dollars. Anything less than this is an expensive and possibly fatal distraction. This book provides a strategic framework for cost efficient engineering of patent portfolios that protect your investments in research and development and that extend the market advantages that these investments provide.

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A comprehensive introduction for scientists engaged in new drug development, analysis, and approvals Each year the pharmaceutical industry worldwide recruits thousands of recent science graduates—especially chemistry, analytical chemistry, pharmacy, and pharmaceutical majors—into its ranks. However, because of their limited background in pharmaceutical analysis most of those new recruits find making the transition from academia to industry very difficult. Designed to assist both recent graduates, as well as experienced chemists or scientists with limited regulatory, compendial or pharmaceutical analysis background, make that transition, Pharmaceutical Analysis for Small Molecules is a concise, yet comprehensive introduction to the drug development process and analysis of chemically synthesized, small molecule drugs. It features contributions by distinguished experts in the field, including editor and author, Dr. Behnam Davani, an analytical chemist with decades of technical management and teaching experience in compendial, regulatory, and industry. This book provides an introduction to pharmaceutical analysis for small molecules (non-biologics) using commonly used techniques for drug characterization and performance tests. The driving force for industry to perform pharmaceutical analyses is submission of such data and supporting documents to regulatory bodies for drug approval in order to market their products. In addition, related required supporting studies including good laboratory/documentation practices including analytical instrument qualification are highlighted in this book. Topics covered include: Drug Approval Process and Regulatory Requirements (private standards) Pharmacopeias and Compendial Approval Process (public standards) Common methods in pharmaceutical analysis (typically compendial) Common Calculations for assays and impurities and other specific tests Analytical Method Validation, Verification, Transfer Specifications including how to handle out of specification (OOS) and out of trend (OOT) Impurities including organic, inorganic, residual solvents and elemental impurities Good Documentation Practices for regulatory environment Management of Analytical Laboratories Analytical Instrument Qualifications including IQ, OQ, PQ and VQ Due to global nature of pharmaceutical industry, other topics on both regulatory (ICH) and Compendial harmonization are also highlighted. Pharmaceutical Analysis for Small Molecules is a valuable working resource for scientists directly or indirectly involved with the drug development process, including analytical chemists, pharmaceutical scientists, pharmacists, and quality control/quality assurance professionals. It also is an excellent text/reference for graduate students in analytical chemistry, pharmacy, pharmaceutical and regulatory sciences.
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