impact of regulatory environment on pharmaceutical industry



Behnam Davani Pharmaceutical Analysis for Small Molecules Behnam Davani Pharmaceutical Analysis for Small Molecules Новинка

Behnam Davani Pharmaceutical Analysis for Small Molecules

9603.03 руб.
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.
Takayuki Shioiri Pharmaceutical Process Chemistry Takayuki Shioiri Pharmaceutical Process Chemistry Новинка

Takayuki Shioiri Pharmaceutical Process Chemistry

17593.05 руб.
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.
Anke-Hilse Maitland-van der Zee Pharmacogenetics and Individualized Therapy Anke-Hilse Maitland-van der Zee Pharmacogenetics and Individualized Therapy Новинка

Anke-Hilse Maitland-van der Zee Pharmacogenetics and Individualized Therapy

10058.11 руб.
This resource provides thorough coverage of pharmacogenetics and its impact on pharmaceuticals, therapeutics, and clinical practice. It opens with the basics of pharmacogenetics, including drug disposition and pharmacodynamics. The following section moves into specific disease areas, including cardiovascular, psychiatry, cancer, asthma/COPD, adverse drug reactions, transplantation, inflammatory bowel disease, and pain medication. Clinical practice and ethical issues make up the third section, with the fourth devoted to technologies like genotyping, genomics, and proteomics. In the fifth part, chapters discuss the impact of key regulatory issues on the pharmaceutical industry.
Nicolas Abatzoglou Pharmaceutical Blending and Mixing Nicolas Abatzoglou Pharmaceutical Blending and Mixing Новинка

Nicolas Abatzoglou Pharmaceutical Blending and Mixing

12595.1 руб.
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.
Lionel Edwards D. Principles and Practice of Pharmaceutical Medicine Lionel Edwards D. Principles and Practice of Pharmaceutical Medicine Новинка

Lionel Edwards D. Principles and Practice of Pharmaceutical Medicine

27657.47 руб.
The new edition of Principles and Practice of Pharmaceutical Medicine is a comprehensive reference guide to all aspects of pharmaceutical medicine. New content includes chapters and coverage on regulatory updates, increasing international harmonization, transitional and probabilistic approaches to drug development, the growing sophistication and regulatory importance of pharmacovigilance, personalized medicine and growth in biotechnology as a source of new experimental drugs.
Sunita Mishra Pharmaceutical Industry in Post TRIPS period:Changing Perspectives Sunita Mishra Pharmaceutical Industry in Post TRIPS period:Changing Perspectives Новинка

Sunita Mishra Pharmaceutical Industry in Post TRIPS period:Changing Perspectives

6104 руб.
After India became a founder member of WTO and accepted the TRIPS agreement, It was apprehended that introduction of pharmaceutical product patents would have a negative impact on the Indian pharmaceutical industry by hampering its growth as the industry would no longer be able to manufacture by reverse engineering or export drugs whose product patents are in effect. However, the stronger patent regime proved a blessing in disguise for the Indian pharmaceutical industry. Contrary to expectations, the Indian pharmaceutical industry has shown a remarkable growth in Exports & R&D. The industry is also leading in DMF filings & ANDA filings with USFDA, a field which was not attended hitherto by the Pharmaceutical firms. The present study discusses the implications of product patents for the Indian pharmaceutical industry both at industry level and at firm level. Different databases have been used for industry level analysis as well as for the analysis of large scale firms, whereas primary data has been used to analyse the small scale firms. The Indian pharmaceutical firms’ responses provide important insights which have implications for firms from other developing countries.
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?

2532.46 руб.
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?
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

13444.25 руб.
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
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

6202 руб.
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.
Stephen Robert Goldman Handbook of Computer and Computerized System Validation for the Pharmaceutical Industry Stephen Robert Goldman Handbook of Computer and Computerized System Validation for the Pharmaceutical Industry Новинка

Stephen Robert Goldman Handbook of Computer and Computerized System Validation for the Pharmaceutical Industry

9677 руб.
Книга "Handbook of Computer and Computerized System Validation for the Pharmaceutical Industry".
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

18132.32 руб.
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.
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

12671.64 руб.
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.
Dennis Douroumis Hot-Melt Extrusion. Pharmaceutical Applications Dennis Douroumis Hot-Melt Extrusion. Pharmaceutical Applications Новинка

Dennis Douroumis Hot-Melt Extrusion. Pharmaceutical Applications

15205.96 руб.
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.
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

12288.24 руб.
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.
Richard Davis K. Managing to the New Regulatory Reality. Doing Business Under the Dodd-Frank Act Richard Davis K. Managing to the New Regulatory Reality. Doing Business Under the Dodd-Frank Act Новинка

Richard Davis K. Managing to the New Regulatory Reality. Doing Business Under the Dodd-Frank Act

3299.34 руб.
How to manage and profit from the new financial regulatory reality Now, more than ever, navigating the new financial regulations is paramount for the survival of many large institutions. Managing to the New Regulatory Reality: Doing Business Under the Dodd-Frank Act provides the most important, need-to-know lessons for private sector management, boards of directors, policymakers, and even regulators, shedding light on the movement from crisis to panic, regulatory reform to winning under continuing financial regulatory uncertainty. Reviews the causes of 2008's financial crisis, and assesses its impact on multiple stakeholders Describes and analyzes the impact of the immediate U.S. and G20 policy and regulatory reactions on financial institutions that the crisis response triggered Explains the legislative policies, and examines how institutions and the financial services industry can make these new policies and regulations work for them All financial institutions, but especially large companies, will have to aggressively manage to the new regulatory reality. Managing to the New Regulatory Reality is the must-have survival guide to sustaining profitability despite all the new red tape.
J. Liebenau Medical Science and Medical Industry. The Formation of the American Pharmaceutical Industry J. Liebenau Medical Science and Medical Industry. The Formation of the American Pharmaceutical Industry Новинка

J. Liebenau Medical Science and Medical Industry. The Formation of the American Pharmaceutical Industry

6527 руб.
Книга "Medical Science and Medical Industry. The Formation of the American Pharmaceutical Industry".
Peter Kleinebudde Continuous Manufacturing of Pharmaceuticals Peter Kleinebudde Continuous Manufacturing of Pharmaceuticals Новинка

Peter Kleinebudde Continuous Manufacturing of Pharmaceuticals

15743.87 руб.
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.
Erik Veldhoen You-Topia. The Impact of the Digital Revolution on Our Work, Our Life and Our Environment Erik Veldhoen You-Topia. The Impact of the Digital Revolution on Our Work, Our Life and Our Environment Новинка

Erik Veldhoen You-Topia. The Impact of the Digital Revolution on Our Work, Our Life and Our Environment

2464 руб.
Книга "You-Topia. The Impact of the Digital Revolution on Our Work, Our Life and Our Environment".
Pam Smith The Emotional Labour of Nursing. Its Impact on Interpersonal Relations, Management and Educational Environment Pam Smith The Emotional Labour of Nursing. Its Impact on Interpersonal Relations, Management and Educational Environment Новинка

Pam Smith The Emotional Labour of Nursing. Its Impact on Interpersonal Relations, Management and Educational Environment

6502 руб.
Книга "The Emotional Labour of Nursing. Its Impact on Interpersonal Relations, Management and Educational Environment".
Michael Perelman The Perverse Economy. The Impact of Markets on People and the Environment Michael Perelman The Perverse Economy. The Impact of Markets on People and the Environment Новинка

Michael Perelman The Perverse Economy. The Impact of Markets on People and the Environment

5564 руб.
Книга "The Perverse Economy. The Impact of Markets on People and the Environment".
Stan Dibben, Mark Dibben Enterprise on the Edge of Industry. Experiencing Corporatisation and Its Impact 1914-2014 Stan Dibben, Mark Dibben Enterprise on the Edge of Industry. Experiencing Corporatisation and Its Impact 1914-2014 Новинка

Stan Dibben, Mark Dibben Enterprise on the Edge of Industry. Experiencing Corporatisation and Its Impact 1914-2014

2839 руб.
Книга "Enterprise on the Edge of Industry. Experiencing Corporatisation and Its Impact 1914-2014".
Rose Bridger Plane Truth. Aviation's Real Impact on People and the Environment Rose Bridger Plane Truth. Aviation's Real Impact on People and the Environment Новинка

Rose Bridger Plane Truth. Aviation's Real Impact on People and the Environment

3814 руб.
As aviation is celebrated as one of the world's fastest growing industries, with passenger numbers and cargo volumes projected to double in the next 20 years, Plane Truth sounds a note of caution.In addition to the environmental impact of airport expansion, devouring farmland and wildlife habitats, and aviation's impact of noise and air pollution on communities, Rose Bridger reveals the extraordinary government subsidies for the aviation industry, encompassing government expenditure on infrastructure to tax breaks, all of which serve to support the industry in the face of rising oil prices and global economic downturn. Disavowing 'greenwashing' claims of fuel-efficient aircraft and alternative fuels that will enable growth without climate change, from British Airways to American Airlines, the symbiotic relationship between aviation and the wider socio-economic problems facing humanity is manifest.
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

9182.98 руб.
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.
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

3214 руб.
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.
Thierry Hamaide Environmental Impact of Polymers Thierry Hamaide Environmental Impact of Polymers Новинка

Thierry Hamaide Environmental Impact of Polymers

15437.74 руб.
This text addresses the common negative perception of polymer materials on the environment with a thorough analysis of what really occurs when industry and academia collaborate to find environmental solutions. The book examines the environmental and social effects of polymer materials and explains methods of quantifying environmental performance. With an emphasis on the importance of education, the authors stress the importance of awareness and activity in negating polymers' environmental impact.
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

12513.24 руб.
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.
Patrick Jjemba K. Pharma-Ecology. The Occurrence and Fate of Pharmaceuticals and Personal Care Products in the Environment Patrick Jjemba K. Pharma-Ecology. The Occurrence and Fate of Pharmaceuticals and Personal Care Products in the Environment Новинка

Patrick Jjemba K. Pharma-Ecology. The Occurrence and Fate of Pharmaceuticals and Personal Care Products in the Environment

12869.63 руб.
The revised edition of the guide to environmental impact of pharmaceuticals and personal care products The revised and updated second edition of Pharma-Ecology joins the health and environmental sciences professions' concern over the occurrence and fate of pharmaceutical and personal care products (PPCPs) in the environment and explores how to best minimize their impact. The text highlights the biological effects of various classes of pharmaceutical compounds under clinical settings, their modes of action, and approximate quantities consumed. The second edition contains the most recent knowledge about the ecological impact of PPCPs as more sensitive detection techniques have become available, since the book was first published. The second edition offers the most up-to-date information on pharma ecology and bridges the gap between medicine, public health, and environmental science. This new edition contains helpful learning objectives for each chapter, as well as a brief section at the end of each chapter that presents a set of open ended questions. This vital resource: • Explores the biological effects of pharmaceutical compounds under clinical settings, their modes of action, approximate quantities consumed • Provides researchers and scientists with critical background data on the environmental impacts of PPCPs • Contains the most current information on PPCPs' ecological impacts, based on new detection techniques • Bridges the gap between medicine, public health, and environmental science Written for ecologists, engineers, microbiologists, pharmacists, toxicologists, chemists, physicians, and veterinarians involved in pollution and environmental analysis, the second edition of Pharma-Ecology contains the most current information available on the environmental impact of pharmaceuticals and personal care products.
Sonigitu Ekpe Comparative study of activities of Sawmilling Industry on the Environment of two selected locations within Southern Nigeria Sonigitu Ekpe Comparative study of activities of Sawmilling Industry on the Environment of two selected locations within Southern Nigeria Новинка

Sonigitu Ekpe Comparative study of activities of Sawmilling Industry on the Environment of two selected locations within Southern Nigeria

3477 руб.
Master's Thesis from the year 2011 in the subject Economy - Environment economics, , language: English, abstract: This work examines the comparative study of activities of Sawmilling Industry on the Environment of two selected locations within Southern Nigeria, Lagos and Delta States between August 2008 and September 2009. The primary data were collected through oral interview and field experiments. While secondary data were from printed materials. The focus has been to compare the various waste generated, its uses and environmental impact on the two locations. Experiments were conducted in the rainy and dry season for the comparative study. The study has been divided into three main areas: volume of waste generated and various uses, effect of type of chain-saw machine used, and impact of sawmilling activities on the environment of the two locations. A natural logarithm transformation of the data was used for some datasets to satisfy assumption of normality and variance homogeneity, means and standard error were back transformed for presentation, specific treatment pairs were compared using a t-test.
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

10214.57 руб.
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.
Kaumudhi Challa Environment Impact Assessment Kaumudhi Challa Environment Impact Assessment Новинка

Kaumudhi Challa Environment Impact Assessment

5707 руб.
Right to development is a basic human right and essential for the economic development as well as providing basic amenities to the people. However the adverse impacts of developmental projects on environment cannot be ignored. Environment Impact Assessment (EIA) is a tool to assess the impacts of a developmental projects on the environment prior to the initiation of the project. Hence the adverse impacts can be reduced by taking adequate precautions. Thus EIA helps the project proponents and authorities to take care of environmental issues during developmental planning and activities.
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

7127 руб.
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...
Salminen Seppo Probiotics and Health Claims Salminen Seppo Probiotics and Health Claims Новинка

Salminen Seppo Probiotics and Health Claims

19003.49 руб.
This book examines the international picture regarding probiotic food applications, placing a particular emphasis on the legal context and assessment procedures of probiotic health claims in the major markets for these products. Health claim legislation is described and the ways in which manufacturers can ensure compliance are discussed. The book also covers the use of meta-analysis to assess available data, and case examples from various regulatory cultures and traditions are included. It will be of interest to food industry scientists, executives and R&D personnel; international regulatory advisers and administrators; researchers, educators and students on food science courses. Key Features: Focuses on health claim legislation for this commercially important food sector Includes chapters on the current situation in all the major world markets including Europe, the USA, Japan, India and China Covers food, feed and pharmaceutical applications of probiotics
Annie Mills Essential Strategies for Financial Services Compliance Annie Mills Essential Strategies for Financial Services Compliance Новинка

Annie Mills Essential Strategies for Financial Services Compliance

4289.88 руб.
A fully updated edition of the definitive guide to financial regulation In recent years, not only has the compliance field become firmly established, but it has seen staggering growth, thanks to never-ending changes in the regulatory environment. As regulation increases still further, the demand for clear guidance on navigating daily compliance issues is greater than ever. Now in its second edition, the highly successful Essential Strategies for Financial Services Compliance has been updated with the latest compliance strategies and regulatory information, making it indispensable for compliance officers, legal firms, and anyone else working with the financial services compliance function. Non-compliance represents a significant material risk for any financial services firm that fails to understand and appropriately apply regulatory standards. This Second Edition of Essential Strategies for Financial Services Compliance makes it easy to digest complex information on the regulatory framework. But this book is far from solely theoretical. A balanced approach means that both the concepts and their application are within reach. Annie Mills and Peter Haines deliver solid advice that can be applied on a day-to-day basis to manage any compliance issues that may arise. Read this book to: Understand the conceptual basis of compliance and the current regulatory environment applicable to the financial services industry Quickly and thoroughly learn the accepted best practices for everyday compliance Get up to date information on the current financial regulatory environment with this new edition Reference detailed advice as issues arise in day-to-day operations This update to the popular first edition of Essential Strategies for Financial Services Compliance will help eliminate non-compliance risk and ensure that your firm is entirely current on its ability to navigate the maze of financial services regulation.
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

11087.68 руб.
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.
Charapov Vladimir Impact of Shadow Banking Regulations on Regulated Institutions Charapov Vladimir Impact of Shadow Banking Regulations on Regulated Institutions Новинка

Charapov Vladimir Impact of Shadow Banking Regulations on Regulated Institutions

7402 руб.
This thesis thoroughly investigates the relationship between regulated institutions, which engage in unregulated activities and the new shadow banking regulations. The purpose of this paper is to establish the impact of these policies on systemic risk arising from shadow banking and to identify possible remaining risks. The methods used in this thesis are literature research and a case study of Deutsche Bank. The author overviews the concept of shadow banking industry and its components. The paper features an extensive analysis of proposed initiatives and passed regulations. A detailed study of Deutsche Bank's role in the events leading up to the 2008 financial crisis identifies 4 areas of focus requiring regulatory attention. The following are cross-referenced with implemented regulation to showcase the impact on the organization.
Vincent Schade The inclusion of aviation in the European Emission Trading Scheme. Analyzing the scope of impact on the aviation industry Vincent Schade The inclusion of aviation in the European Emission Trading Scheme. Analyzing the scope of impact on the aviation industry Новинка

Vincent Schade The inclusion of aviation in the European Emission Trading Scheme. Analyzing the scope of impact on the aviation industry

8202 руб.
A significant volume of literature already exists concerning the inclusion of aviation in the EU-ETS. Most of the research laid its focus on specific industry levels such as the individual airline, the aviation industry in general or macroeconomic aspects. In this context, these studies tried to anticipate market reactions triggered by the EU-ETS by analyzing specific issues such as the financial impact on airlines, changes in competitive behavior or implications for the overall industry development. As a consequence, the existing studies took only a limited market view and made assumptions about expected developments in specific fields of the aviation industry. However, at the time of writing this thesis, conclusions about the scope of impact could hardly be drawn from existing impact assessments because of the wide range of issues that exceeded the scope of most impact studies. Hence, a broader research approach is needed which takes different analytical perspectives to describe the scope of impact of the EU-ETS and depict potential effects for the aviation industry.
Muhammad Zahid Asif Impact of Promotional Activities on Sale Volume of Pharmaceuticals Muhammad Zahid Asif Impact of Promotional Activities on Sale Volume of Pharmaceuticals Новинка

Muhammad Zahid Asif Impact of Promotional Activities on Sale Volume of Pharmaceuticals

4358 руб.
Globally, The pharmaceutical industry is under severe inspection. Government agencies, special interest groups and the media was closely observing the activities of pharmaceutical industry. Opponents condemn pharmaceutical promotional activities as useless and excessive wastage of resources. However, supporters of pharmaceutical promotions justify that marketing expenditures gave innovative chance to recover high R,D expenditures. Furthermore, marketing might serve as a communication channel to educate health care professionals and expose patients to information that may help to improve their health and gave medical treatment options.Pharmaceutical Promotional activities are distinct from other kinds of selling. It requires specialized efforts by the pharmaceutical companies to carve a niche for themselves for better market share in the marketplace with a great number of players in the market. In pharmaceutical market with a clutter of products, it is virtually impossible for a doctor or physician to remember all brands. This could be substantiated by looking at number of brands available in the market for the same molecule or drug.
Chintan Patel,Sapan Parikh and Rohan Satwara Project management for pharmaceutical industry Chintan Patel,Sapan Parikh and Rohan Satwara Project management for pharmaceutical industry Новинка

Chintan Patel,Sapan Parikh and Rohan Satwara Project management for pharmaceutical industry

6104 руб.
This book is related to management principles and practice including various key factors for managing new projects for pharmaceutical industry. From this book everyone may understand the requirement for smooth projects management for new product development in pharmaceutical industry. Various steps which are required to drive project in smooth manner. The information of this book is useful to those who wants to understand the technical and also commercial aspects for a new project development. Key factors are related to indian pharmaceutical industry and various management skill which are important for good management practice.This book includes various sequence of task and the outcome from the completion of each task, which is essential to drive a new project in smooth manner.Some technical information and sum facts related to pharmaceutical industrial scenario across the world.
Andrew Green XVA. Credit, Funding and Capital Valuation Adjustments Andrew Green XVA. Credit, Funding and Capital Valuation Adjustments Новинка

Andrew Green XVA. Credit, Funding and Capital Valuation Adjustments

6269.82 руб.
Thorough, accessible coverage of the key issues in XVA XVA – Credit, Funding and Capital Valuation Adjustments provides specialists and non-specialists alike with an up-to-date and comprehensive treatment of Credit, Debit, Funding, Capital and Margin Valuation Adjustment (CVA, DVA, FVA, KVA and MVA), including modelling frameworks as well as broader IT engineering challenges. Written by an industry expert, this book navigates you through the complexities of XVA, discussing in detail the very latest developments in valuation adjustments including the impact of regulatory capital and margin requirements arising from CCPs and bilateral initial margin. The book presents a unified approach to modelling valuation adjustments including credit risk, funding and regulatory effects. The practical implementation of XVA models using Monte Carlo techniques is also central to the book. You'll also find thorough coverage of how XVA sensitivities can be accurately measured, the technological challenges presented by XVA, the use of grid computing on CPU and GPU platforms, the management of data, and how the regulatory framework introduced under Basel III presents massive implications for the finance industry. Explores how XVA models have developed in the aftermath of the credit crisis The only text to focus on the XVA adjustments rather than the broader topic of counterparty risk. Covers regulatory change since the credit crisis including Basel III and the impact regulation has had on the pricing of derivatives. Covers the very latest valuation adjustments, KVA and MVA. The author is a regular speaker and trainer at industry events, including WBS training, Marcus Evans, ICBI, Infoline and RISK If you're a quantitative analyst, trader, banking manager, risk manager, finance and audit professional, academic or student looking to expand your knowledge of XVA, this book has you covered.
Eshi Agbadua Impact of restructuring and privatization on the performance of the electricity sector in Nigeria Eshi Agbadua Impact of restructuring and privatization on the performance of the electricity sector in Nigeria Новинка

Eshi Agbadua Impact of restructuring and privatization on the performance of the electricity sector in Nigeria

3314 руб.
Master's Thesis from the year 2015 in the subject Economics - Case Scenarios, grade: 65, Aston University, language: English, abstract: The slow and deteriorating performance of the electricity power sector over the last few decades triggered the Federal Government of Nigeria to embark on a power sector reform program. This study examines the impact of the power sector reform (restructuring and privatization) on the performance of the electricity sector in Nigeria over the past twenty-five (25) years. Relevant electricity indicators are used to access the performance changes in three significant period; pure state-ownership, transition (restructuring and unbundling) and full privatization of the sector.The study also assesses how the effect of the economic environment, regulatory governance and political climate/effectiveness within the period contributes to the improvements in the electricity sector. The results shows that privatization is associated with improvement in the technical efficiency, access to electricity, electricity consumption per capita and an increase in electricity tariff in the sector. Furthermore, the results highlight the significant relationship between regulatory governance and a robust economy on the performance changes observed in the power industry.
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

9132.9 руб.
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.
John LaMattina L. Drug Truths. Dispelling the Myths About Pharma R & D John LaMattina L. Drug Truths. Dispelling the Myths About Pharma R & D Новинка

John LaMattina L. Drug Truths. Dispelling the Myths About Pharma R & D

2532.46 руб.
This book answers the questions about the process and costs of pharmaceutical R & D in a compelling narrative focused on the discovery and development of important new medicines. It gives an insider's account of the pharmaceutical industry drug discovery process, the very real costs of misperceptions about the industry, the high stakes–both economic and scientific–of developing drugs, the triumphs that come when new compounds reach the market and save lives, and the despair that follows when new compounds fail. In the book, John LaMattina, former president of Pfizer Global Research and Development, weaves themes critical to a vital drug discovery environment in the context. This is a story that Dr. LaMattina is uniquely qualified to tell.
Ann Newman Pharmaceutical Amorphous Solid Dispersions Ann Newman Pharmaceutical Amorphous Solid Dispersions Новинка

Ann Newman Pharmaceutical Amorphous Solid Dispersions

13905.63 руб.
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
Richard Kay Statistical Thinking for Non-Statisticians in Drug Regulation Richard Kay Statistical Thinking for Non-Statisticians in Drug Regulation Новинка

Richard Kay Statistical Thinking for Non-Statisticians in Drug Regulation

8153.41 руб.
Statistical Thinking for Non-Statisticians in Drug Regulation, Second Edition, is a need-to-know guide to understanding statistical methodology, statistical data and results within drug development and clinical trials. It provides non-statisticians working in the pharmaceutical and medical device industries with an accessible introduction to the knowledge they need when working with statistical information and communicating with statisticians. It covers the statistical aspects of design, conduct, analysis and presentation of data from clinical trials in drug regulation and improves the ability to read, understand and critically appraise statistical methodology in papers and reports. As such, it is directly concerned with the day-to-day practice and the regulatory requirements of drug development and clinical trials. Fully conversant with current regulatory requirements, this second edition includes five new chapters covering Bayesian statistics, adaptive designs, observational studies, methods for safety analysis and monitoring and statistics for diagnosis. Authored by a respected lecturer and consultant to the pharmaceutical industry, Statistical Thinking for Non-Statisticians in Drug Regulation is an ideal guide for physicians, clinical research scientists, managers and associates, data managers, medical writers, regulatory personnel and for all non-statisticians working and learning within the pharmaceutical industry.
Karin Bosshard Hedge Fund Regulation in Europe and its Impact on Switzerland Karin Bosshard Hedge Fund Regulation in Europe and its Impact on Switzerland Новинка

Karin Bosshard Hedge Fund Regulation in Europe and its Impact on Switzerland

4120 руб.
This book examined the legal and economic impact of the European Union’s Alternative Investment Fund Manager Directive (AIFMD) on the Swiss hedge fund landscape in order to understand how the Swiss policy maker can ideally react to the changed regulatory framework in the European Union. The legal impact of the AIFMD on Swiss hedge fund managers and advisors is derived from the interpreting relevant legislative texts and is supplemented by the opinions of experts. An economic analysis contains an evaluation of the options available to hedge fund managers or advisors for reacting to the changes in the Swiss legal framework, supported by estimations of industry experts, hedge fund managers and advisors.
Mohan R. Lavi The Impact of IFRS on Industry Mohan R. Lavi The Impact of IFRS on Industry Новинка

Mohan R. Lavi The Impact of IFRS on Industry

6599.81 руб.
The industry-specific guide to IFRS interpretation and application One of the biggest challenges of any reporting standard is how best to interpret and implement it in the context of a specific company or industry, given that each industry has its own intricacies and nuances. The Impact of IFRS on Industry provides specific guidance on applying IFRS in a diverse range of sectors. Opening with an overview of IFRS, including a summary of all the standards, the book goes on to provide detailed coverage of the standards that can impact all industries, including IAS-40, IFRS 1, and IFRS 5. Thereafter, it offers practical advice and guidance on the application of IFRS in specific industries, including automotive; oil and gas; bio-sciences; infrastructure; airlines; media and communications; government-owned entities; mining; software; banking and financial services; insurance; FMCG; shipping; pharmaceuticals; telecoms; real estate and construction; power; SMEs; retail; e-commerce; and the service sector. The book concludes with a discussion on the collateral impact of implementing IFRS and how forthcoming IFRS Standards could impact specific industries. Worked examples are used throughout to demonstrate how the standards are applied in practice. Understand the IFRS standards comprehensively Learn which standards impact all industries Examine the ways in which IFRS is applied in practice See how different standards are applied in specific industries Suitable as a quick reference or a comprehensive guide, The Impact of IFRS on Industry gives you the real-world IFRS answers you need.
Rapuluchukwu Nduka Telecommunications Regulation in Nigeria Rapuluchukwu Nduka Telecommunications Regulation in Nigeria Новинка

Rapuluchukwu Nduka Telecommunications Regulation in Nigeria

8377 руб.
Telecommunication is very essential to the growth of any modern economy. Formulating the right policies to regulate the human, technological, infrastructural and economic landscape of the telecommunication industry holds the key to the growth of the industry. Telecommunication and its regulation in Nigeria have come a long way passing through various phases of development that is however connected with the various political phases of the nation. The deregulation of the telecommunication industry in Nigeria opened up a competitive environment in the telecommunication industry and caused a major socio-economic boost in the industry and the entire nation. Although there has been some improvements, there are still various issues that the telecommunication industry and its regulation in Nigeria still grapple with. This book examines the developmental stages of telecommunication and its regulation in Nigeria and assesses the regulatory structure of the industry in line with modern ideal regulatory expectations. This book identifies some issues that plague the industry and suggests factors that will enhance the growth of the telecommunication industry and its regulation.
United States Department of Agriculture Service and regulatory announcements bureau of animal industry United States Department of Agriculture Service and regulatory announcements bureau of animal industry Новинка

United States Department of Agriculture Service and regulatory announcements bureau of animal industry

686 руб.
Эта книга — репринт оригинального издания (издательство "[Washington :Govt. Print. Off.]", 1935 год), созданный на основе электронной копии высокого разрешения, которую очистили и обработали вручную, сохранив структуру и орфографию оригинального издания. Редкие, забытые и малоизвестные книги, изданные с петровских времен до наших дней, вновь доступны в виде печатных книг.Service and regulatory announcements bureau of animal industry
The American Impact on Postwar Germany The American Impact on Postwar Germany Новинка

The American Impact on Postwar Germany

4039 руб.
It is only with the benefit of hindsight that the Germans have become acutely aware of how profound and comprehensive was the impact of the United States on their society after 1945.This volume reflect the ubiquitousness of this impact and examines the German responses to it.Contributions by well-known scholars cover politics, industry, social life and mass culture.
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

11523.64 руб.
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
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

6577 руб.
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.
Isha Jaswal and Nandita Kandal Indian Pharmaceutical Industry :Boon or Bane Isha Jaswal and Nandita Kandal Indian Pharmaceutical Industry :Boon or Bane Новинка

Isha Jaswal and Nandita Kandal Indian Pharmaceutical Industry :Boon or Bane

2850 руб.
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.
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

13433 руб.
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.
Obinna Izuchukwu Okafor Post Crisis Reforms in the Nigerian Banking Industry Obinna Izuchukwu Okafor Post Crisis Reforms in the Nigerian Banking Industry Новинка

Obinna Izuchukwu Okafor Post Crisis Reforms in the Nigerian Banking Industry

3212 руб.
After the devastating effect of the 2008 global financial crisis, financial regulatory authorities around the world started enacting various forms of reform policies to stabilise the financial markets and prevent future occurrence of such crisis. This book examines the reform policies being implemented in Nigeria, with the aim of assessing the likely impact on the financial and real sectors of the economy.
AICPA Audit and Accounting Guide Depository and Lending Institutions. Banks and Savings Institutions, Credit Unions, Finance Companies, and Mortgage Companies AICPA Audit and Accounting Guide Depository and Lending Institutions. Banks and Savings Institutions, Credit Unions, Finance Companies, and Mortgage Companies Новинка

AICPA Audit and Accounting Guide Depository and Lending Institutions. Banks and Savings Institutions, Credit Unions, Finance Companies, and Mortgage Companies

7605.89 руб.
The 2017 edition of this industry standard resource offers clear and practical guidance of audit and accounting issues such as transfers and servicing, troubled debt restructurings, financing receivables and the allowance for loan losses, and fair value accounting. It also provides direction for institutions assessing their operations and internal controls for regulatory considerations as well as discussions on existing regulatory reporting matters. Updates include: SAS No. 132, The Auditor's Consideration of an Entity’s Ability to Continue as a Going Concern SSAE No. 18, Attestation Standards: Clarification and Recodification Note: FASB ASU No. 2016-13 will have a significant impact on the guide; however, incorporation of guidance will not occur until the 2018 or 2019 edition of the guide.
Vera Mihajlovic-Madzarevic Clinical Trials Audit Preparation. A Guide for Good Clinical Practice (GCP) Inspections Vera Mihajlovic-Madzarevic Clinical Trials Audit Preparation. A Guide for Good Clinical Practice (GCP) Inspections Новинка

Vera Mihajlovic-Madzarevic Clinical Trials Audit Preparation. A Guide for Good Clinical Practice (GCP) Inspections

8707.79 руб.
A must-have guide for any professional in the drug manufacturing industry The Good Clinical Practice (GCP) audit is a tedious but necessary exercise that assures that all parties do their job properly and in compliance with the applicable FDA code. Clinical Trials Audit Preparation demystifies the audit process for all parties involved, including clinical research sponsors, clinical investigators, and institutional review boards. This book provides a step-by-step explanation of the FDA audit procedures for clinical trials and of how pharmaceutical companies, clinical investigators, and institutional review boards should prepare for regulatory audits. The book emphasizes the processes and procedures that should be implemented before a clinical audit occurs, making this an imperative guide to any professional in the drug manufacturing industry, including drug manufacturing companies, regulatory affairs personnel, clinical investigators, and quality assurance professionals. Among the topics discussed: Good Clinical Practices and therapeutic product development in clinical research The roles of the sponsor of a clinical investigation, the IRB, or independent ethics committee The roles and responsibilities of the clinical trial investigator The inspection preparation The Audit Report and the Form 483 Warning letters issued to clinical investigators and clinical trial sponsors and their impact on product development
Robin Harris K. NMR in Pharmaceutical Science Robin Harris K. NMR in Pharmaceutical Science Новинка

Robin Harris K. NMR in Pharmaceutical Science

10495.92 руб.
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
Casazza Jack Understanding Electric Power Systems. An Overview of the Technology, the Marketplace, and Government Regulations Casazza Jack Understanding Electric Power Systems. An Overview of the Technology, the Marketplace, and Government Regulations Новинка

Casazza Jack Understanding Electric Power Systems. An Overview of the Technology, the Marketplace, and Government Regulations

8074.21 руб.
Technological advances and changes in government policy and regulation have altered the electric power industry in recent years and will continue to impact it for quite some time. Fully updated with the latest changes to regulation, structure, and technology, this new edition of Understanding Electric Power Systems offers a real-world view of the industry, explaining how it operates, how it is structured, and how electricity is regulated and priced. It includes extensive references for the reader and will be especially useful to lawyers, government officials, regulators, engineers, and students, as well as the general public. The book explains the physical functioning of electric power systems, the electric power business in today's environment, and the related institutions, including recent changes in the roles of the Federal Energy Regulatory Commission and the North American Reliability Company. Significant changes that are affecting the industry are covered in this new edition, including: The expanded role of the federal government in the planning and operation of the nation's electric utilities New energy laws and a large number of FERC regulations implementing these laws Concerns over global warming and potential impacts on the electric industry Pressures for expansion of the electric grid and the implementation of «smart-grid» technologies The growing importance of various energy-storage technologies and renewable energy sources New nuclear generation technologies The 2009 economic stimulus package
Saura Sahu C. Toxicology and Epigenetics Saura Sahu C. Toxicology and Epigenetics Новинка

Saura Sahu C. Toxicology and Epigenetics

19641.03 руб.
Epigenetics is the study of both heritable and non-heritable changes in the regulation of gene activity and expression that occur without an alteration in the DNA sequence. This dynamic and rapidly developing discipline is making its impact across the biomedical sciences, in particular in toxicology where epigenetic differences can mean that different individuals respond differently to the same drug or chemical. Toxicology and Epigenetics reflects the multidimensional character of this emerging area of toxicology, describing cutting-edge molecular technologies to unravel epigenetic changes, the use of in vivo and in vitro models, as well as the potential use of toxicological epigenetics in regulatory environments. An international team of experts consider the interplay between epigenetics and toxicology in a number of areas, including environmental, nutritional, pharmacological, and computational toxicology, nanomaterials, proteomics and metabolomics, and cancer research. Topics covered include: environment, epigenetics and diseases DNA methylation and toxicogenomics chromatin at the intersection of disease and therapy epigenomic actions of environmental arsenicals environment, epigenetics and cardiovascular health toxicology, epigenetics and autoimmunity ocular epigenomics: potential sites of environmental impact in development and disease nuclear RNA silencing and related phenomena in animals epigenomics – impact for drug safety sciences methods of global epigenomic profiling transcriptomics: applications in epigenetic toxicology Toxicology and Epigenetics is an essential insight into the current trends and future directions of research in this rapidly expanding field for investigators, toxicologists, risk assessors and regulators in academia, industry and government.
Отсутствует Banking Law and Practice Отсутствует Banking Law and Practice Новинка

Отсутствует Banking Law and Practice

4157.88 руб.
A solid understanding of how banks operate is crucial to grasp the functioning of modern society. Banks are an intrinsic part of business, finance, and everyday life. Modern banking is regulated by a sophisticated set of laws and regulations that are constantly evolving. Banking Law and Practice from the Hong Kong Institute of Bankers outlines and explains these laws and regulations clearly and in detail. This regulatory framework has a deep impact on banks, bankers, and anyone that deals with them, which is the overwhelming majority of society. This high level of impact makes Banking Law and Practice an important book as well as a necessary and authoritative reference for industry professionals, students, and the public at large. Banking Law and Practice discusses a range of topics that have a direct bearing on the day-to-day operations of banks, from contracts to how to ensure safe and secure lending. It examines the development and current state of banking legislation and regulation and facilitates bankers and their institutions to shape their practice to meet all the necessary legal and regulatory requirements. Students, industry professionals, and the public at large will welcome the thorough and clear explanations of the legal and regulatory framework in which banks operate. This book is essential reading for candidates studying for the HKIB Associateship Examination and anyone else seeking expert knowledge of the legal and regulatory structure affecting banks in Hong Kong. Topics covered in this book include: Contractual Relationships Code of Banking Practice Money Laundering Negotiable Instruments Law Related to Securities Bankruptcy and Insolvency

кешбака
Страницы:


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.
Продажа impact of regulatory environment on pharmaceutical industry лучших цены всего мира
Посредством этого сайта магазина - каталога товаров мы очень легко осуществляем продажу impact of regulatory environment on pharmaceutical industry у одного из интернет-магазинов проверенных фирм. Определитесь с вашими предпочтениями один интернет-магазин, с лучшей ценой продукта. Прочитав рекомендации по продаже impact of regulatory environment on pharmaceutical industry легко охарактеризовать производителя как превосходную и доступную фирму.