Описание: Gary Gereffi first explains how foreign corporations took over the flourishing Mexican steroid industry in the 1950s and 1960s and thwarted the country`s later attempts to establish a more equitable distribution of industry benefits. In this valuable theoretical contribution Professor Gereffi uses the Mexican industry`s plight as a crucial-case tes
Since sterile filtration and purification steps are becoming more prevalent and critical within medicinal drug manufacturing, the third edition of Filtration and Purification in the Biopharmaceutical Industry greatly expands its focus with extensive new material on the critical role of purification and advances in filtration science and technology. It provides state-of-the-science information on all aspects of bioprocessing including the current methods, processes, technologies and equipment. It also covers industry standards and regulatory requirements for the pharmaceutical and biopharmaceutical industries. The book is an essential, comprehensive source for all involved in filtration and purification practices, training and compliance. It describes such technologies as viral retentive filters, membrane chromatography, downstream processing, cell harvesting, and sterile filtration.
Features:
Addresses recent biotechnology-related processes and advanced technologies such as viral retentive filters, membrane chromatography, downstream processing, cell harvesting, and sterile filtration of medium, buffer and end product
Presents detailed updates on the latest FDA and EMA regulatory requirements involving filtration and purification practices, as well as discussions on best practises in filter integrity testing
Describes current industry quality standards and validation requirements and provides guidance for compliance, not just from an end-user perspective, but also supplier requirement
It discusses the advantages of single-use process technologies and the qualification needs
Sterilizing grade filtration qualification and process validation is presented in detail to gain the understanding of the regulatory needs
The book has been compilated by highly experienced contributors in the field of pharmaceutical and biopharmaceutical processing. Each specific topic has been thoroughly examined by a subject matter expert.
Описание: Drawing on a wealth of archival material, this book combines legal, medical, and business history to offer a sweeping new interpretation of the origins of the complex and often troubling relationship between the pharmaceutical industry and medical practice today.
Описание: Each year hundreds of new drugs are approved for the marketplace. The approval of a single new drug is the result of years of screening tens of thousands of compounds, performing pre-clinical research on their effects, and designing, implementing, and analyzing the results of clinical trials. This book provides a general guide to statistical methods used in the pharmaceutical industry, and is aimed at graduate students and researchers who want to know more about statistical applications in all phases of the drug development process. The 19 chapters authored by over 30 statisticians working in the industry follow the general sequence of drug development, from pre-clinical research and saftey assessment to dose finding, safety studies, large clinical trials, analysis of health economic data, and fianlly manufacturing and production. Special topics such as single patient analysis and the impact of patient compliance show the broad spectrum of applications of data analysis methods. Each chapter illustrates a practical problem using data from actual studies by describing the study, the data, the methods, and the results. All of the analyses are done with S-PLUS, and the data and code are provided both in appendices to the chapters and on the companion Springer-Verlag web site, making it possible to reproduce the results and extend the analyses. Prior knowledge of the software is not required to follow the analyses. Steven P. Millard is a statistical consultant and also Manager of Consulting Services for MathSoft, Inc. (Data Analysis Products Division.) He has applied statistical methods to projects ranging from quality control in bioassay to measuring water quality to automating home appraisal, and has taught courses in S-PLUS for over 10 years. He is the author of the book Environmental Statistics with S-PLUS (CRC Press) as well as the S-PLUS add-in module ENVIRONMENTALSTATS for S-PLUS. Andreas Krause is a statistical consultant in the pharmaceutical industry and works for Novartis Pharma AG. He has extensive experience in graphical and numerical data analysis as well as programming, has taught numerous classes with and on S-PLUS, and is an S_PLUS user from the early days on. He is also author of the book The Basics of S and S-PLUS (Springer).
Автор: Hoffman, Daniel , Bowditch, Allan Название: The Global Pharmaceutical Industry ISBN: 0367514230 ISBN-13(EAN): 9780367514235 Издательство: Taylor&Francis Рейтинг: Цена: 6430.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: The pharmaceutical industry plays a hugely important role in the health care system and economy, and this book offers greater understanding of the strategies used by drug makers to charge high prices and boost prescriptions to generate profits demanded by Wall Street.
Автор: Hoffman, Daniel , Bowditch, Allan Название: The Global Pharmaceutical Industry ISBN: 0367485516 ISBN-13(EAN): 9780367485511 Издательство: Taylor&Francis Рейтинг: Цена: 22202.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: The pharmaceutical industry plays a hugely important role in the health care system and economy, and this book offers greater understanding of the strategies used by drug makers to charge high prices and boost prescriptions to generate profits demanded by Wall Street.
Автор: Piachaud Название: Outsourcing of R&D in the Pharmaceutical Industry ISBN: 140393729X ISBN-13(EAN): 9781403937292 Издательство: Springer Рейтинг: Цена: 16769.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: This book examines the strategic aspects of outsourcing in relation to the firm. Although the book is based on a case study of the pharmaceutical industry, the general principles derived from the Strategic Sourcing Model are generic in nature and the model can be applied to instances of outsourcing in other industries.
Автор: Lerer Название: Digital Strategies in the Pharmaceutical Industry ISBN: 1403903794 ISBN-13(EAN): 9781403903792 Издательство: Springer Рейтинг: Цена: 11179.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: This book is a comprehensive review of the current state of digital innovation, Internet activity and e-business in the life sciences arena and a practical guide for managers planning, developing and implementing e-strategies in the pharmaceutical industry.
Описание: This book examines the nature and extent of competition in the pharmaceutical industry and analyses the interaction between market structure and selected elements of the marketing mix.
Описание: Examines the cases of several historic and high-profile drugs in order to discuss the future of the pharmaceutical industry.
Автор: Ali Javed, Baboota Sanjula Название: Regulatory Affairs in the Pharmaceutical Industry ISBN: 0128222115 ISBN-13(EAN): 9780128222119 Издательство: Elsevier Science Рейтинг: Цена: 26107.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание:
Regulatory Affairs in the Pharmaceutical Industry is a comprehensive reference that compiles all the information available pertaining to regulatory procedures currently followed by the pharmaceutical industry. Designed to impart advanced knowledge and skills required to learn the various concepts of regulatory affairs, the content covers new drugs, generic drugs and their development, regulatory filings in different countries, different phases of clinical trials, and the submission of regulatory documents like IND (Investigational New Drug), NDA (New Drug Application) and ANDA (Abbreviated New Drug Application).
Chapters cover documentation in the pharmaceutical industry, generic drug development, code of Federal Regulation (CFR), the ANDA regulatory approval process, the process and documentation for US registration of foreign drugs, the regulation of combination products and medical devices, the CTD and ECTD formats, and much more.
Описание: This book examines the nature and extent of competition in the pharmaceutical industry and analyses the interaction between market structure and selected elements of the marketing mix.
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