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.
Автор: Abraham Название: Regulation of the Pharmaceutical Industry ISBN: 0333790448 ISBN-13(EAN): 9780333790441 Издательство: Springer Рейтинг: Цена: 18866.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: How are pharmaceutical technologies developed and controlled in our societies? This unique collection brings together the work of social scientists, ethicists, lawyers and policy analysts on regulation, ethics and innovation in the pharmaceutical industry.
Автор: Min Ding; Jehoshua Eliashberg; Stefan Stremersch Название: Innovation and Marketing in the Pharmaceutical Industry ISBN: 1461478006 ISBN-13(EAN): 9781461478003 Издательство: Springer Рейтинг: Цена: 32142.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: This volume details state-of-the art research findings and new conceptual thinking related to pharmaceutical marketing. It covers all major aspects, including R&D, promotion, pricing, branding, competitive strategy, portfolio analysis.
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
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: 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).
This book examines the impact of economic reforms in India on the pharmaceutical industry and access to medicines. It traces the changing production and trade pattern of the industry, research and development (R&D) preferences and strategies of Indian pharmaceutical firms, patent system alongside pricing policy measures and their shortcomings. It also analyses the public health financing system in India driven largely by out-of-pocket expenditure -- about 60 per cent -- and characterised by very high share of medicines in total health expenditure.
A masterful insight into a topical area, the work will be indispensable to those working on pharmaceutical industry and public policy. It will be of interest to researchers, scholars, students, and policy-makers of economics, industrial policy, public policy, intellectual property rights and health financing.
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.
Автор: Maclennan Название: Brand Planning for the Pharmaceutical Industry ISBN: 1138247820 ISBN-13(EAN): 9781138247826 Издательство: Taylor&Francis Рейтинг: Цена: 8573.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: Written by John Lidstone and Janice MacLennan, the second edition of Marketing Planning for the Pharmaceutical Industry became accepted as the bible for the industry. In this new companion book Janice MacLennan picks up two of the themes touched on in Marketing Planning - market segmentation and branding, and the inter-relationship between these two - and with this book makes them key topics for discussion. Brand Planning for the Pharmaceutical Industry begins by exploring what branding is and why it is of importance, particularly to the pharmaceutical sector. The book then goes on to show how branding can be integrated into the early stages of the commercialization process for new products, both in theory and in the 'real' world. The book provides a step-by-step guide to brand planning, using market segmentation as the starting point. The book is split into two parts, the first dealing comprehensively with brand planning for products yet to get to the market, with the second part applying the same process to products that are already on the market. Both parts are extremely pragmatic, full of pertinent examples and insights from the pharmaceutical industry, and are directly applicable to your own brand planning. Brand Planning for the Pharmaceutical Industry concludes by confronting the problems that organizations are likely to have in actually making brand planning an integral part of their work and presents strategies for dealing with them.
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.
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