Автор: Rick Ng Название: Drugs: From Discovery to Approval ISBN: 1118907272 ISBN-13(EAN): 9781118907276 Издательство: Wiley Рейтинг: Цена: 88650.00 T Наличие на складе: Есть у поставщика Поставка под заказ. Описание: The third edition of this best–selling book continues to offer a user–friendly, step–by–step introduction to all the key processes involved in bringing a drug to the market, including the performance of pre–clinical studies, the conduct of human clinical trials, regulatory controls, and even the manufacturing processes for pharmaceutical products. Concise and easy to read, Drugs: From Discovery to Approval, Third Edition quickly introduces basic concepts and then moves on to discuss target selection and the drug discovery process for both small and large molecular drugs. The third edition incorporates the latest developments and updates in the pharmaceutical community, provides more comprehensive coverage of topics, and includes more materials and case studies suited to college and university use. Biotechnology is a dynamic field with changes across R&D, clinical trials, manufacturing, and regulatory processes; the third edition of the text provides timely updates for those in this rapidly growing field. • Revised edition will have greater appeal to students with the inclusion of more materials and case studies suited to college and university use • Includes the latest developments and updates • Increased appeal by provision of more comprehensive topics
Название: Preparing for FDA Pre-Approval Inspections ISBN: 0367452715 ISBN-13(EAN): 9780367452711 Издательство: Taylor&Francis Рейтинг: Цена: 63280.00 T Наличие на складе: Есть у поставщика Поставка под заказ. Описание:
This Second Edition is an essential guide to preparing for FDA pre-approval inspections--taking into account current trends in FDA expectations and inspection activities, such as the GMPs of the 21st Century, quality systems-based approach to inspections, risk-based inspections, quality by design, process analytical technology, design space, etc. The goal of this book is to help organizations gain rapid regulatory approval.
Pharmaceutical Pre-Approval Inspections: A Guide to Regulatory Success, Second Edition:
chronicles the major shifts in inspection activity as evidenced by a systems-based approach to inspections
demonstrates what each area of pharmaceutical development, from research and development to training, is expected to provide to inspectors
focuses on traditional development and submission activities, but also discusses cases where the transfer is from a domestic site to an international facility
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