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Preparing for FDA Pre-Approval Inspections, 


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Цена: 63280.00T
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Наличие: Поставка под заказ.  Есть в наличии на складе поставщика.
Склад Америка: 209 шт.  
При оформлении заказа до: 2025-08-18
Ориентировочная дата поставки: конец Сентября - начало Октября
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Название:  Preparing for FDA Pre-Approval Inspections
ISBN: 9780367452711
Издательство: Taylor&Francis
Классификация:
ISBN-10: 0367452715
Обложка/Формат: Paperback
Страницы: 300
Вес: 0.56 кг.
Дата издания: 29.11.2019
Язык: English
Издание: 2 ed
Иллюстрации: 19 tables, black and white; 1 halftones, black and white; 66 illustrations, black and white
Размер: 229 x 152 x 16
Читательская аудитория: Tertiary education (us: college)
Основная тема: Analysis & Pharmaceutical Quality
Подзаголовок: A Guide to Regulatory Success, Second Edition
Ссылка на Издательство: Link
Рейтинг:
Поставляется из: Европейский союз
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


Drugs: From Discovery to Approval

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

Plastics Flammability Handbook 4e: Principles, Regulations, Testing, and Approval

Автор: Troitzsch Jьrgen, Antonatus Edith
Название: Plastics Flammability Handbook 4e: Principles, Regulations, Testing, and Approval
ISBN: 1569907625 ISBN-13(EAN): 9781569907627
Издательство: Mare Nostrum (Eurospan)
Рейтинг:
Цена: 277190.00 T
Наличие на складе: Нет в наличии.
Описание: Plastics flammability is a highly important consideration in many industries, including construction, mass transportation, and electrical and electronic equipment. This comprehensive handbook is unrivalled as the definitive source of information on the reaction of plastics to fire, as well as on the relevant regulations and testing methods.


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