Fundamentals of Biologicals Regulation, Sheets, Rebecca
Новое издание
Автор: By Rebecca Sheets, PhD, CAPT (Retired), USPHS, Pri Название: Fundamentals of Biologicals Regulation ISBN: 0443219885 ISBN-13(EAN): 9780443219887 Издательство: Elsevier Science Цена: 19370.00 р. Наличие на складе: Нет в наличии. Описание: Fundamentals of Biologicals Regulation: Vaccines and Biotechnology Medicines, Second Edition serves as an introduction to the international regulatory arena in which biologicals are developed, offering an overview of processes and insights into the scientific concepts underpinning global regulations. The book provides in-depth coverage of Quality by Design, Combination Products, Quality Target Product Profiles, Risk Management Plans, REMS, and switching from reliance on in vivo to in vitro analytical methods. It reflects new developments and processes accelerated by the COVID-19 vaccine experience, including emergency use authorizations and conditional marking authorizations. New pedagogic elements and case studies have been added to improve learning outcomes.This book provides multiple levels of readership, with guidance on basic concepts, a detailed look at regulatory challenges, and practical insights into how regulators consider regulatory science and regulatory process issues across various regions, with an emphasis on the European Medicines Agency and the U.S. Food and Drug Administration.
Автор: Y.H. Caplan; Amanda J. Jenkins Название: Drug Testing in Alternate Biological Specimens ISBN: 1617377325 ISBN-13(EAN): 9781617377327 Издательство: Springer Рейтинг: Цена: 27951.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: Although the specimen of choice in the US drug testing industry is urine, and serum in clinical medicine, interest has recently grown in the use of other matrices as drug testing media. This book provides researchers and forensic toxicologists with a convenient general text summarizing the state of knowledge today.
Автор: Evens Название: Drug and Biological Development ISBN: 0387329781 ISBN-13(EAN): 9780387329789 Издательство: Springer Рейтинг: Цена: 12850.00 р. Наличие на складе: Нет в наличии.
Описание: The book is a complete discussion of product development in the pharmaceutical and biotechnology industries from discovery, to product launch, and through life cycle management. Format is optimized for education and training of health care professionals, especially fellows in training (MD, PharmD, PhD), at universities. Format of the book is a set of figures, tables and lists, that can become power-point style slides as well, and the detailed narrative descriptions, including real-life examples, illustrations, controversies in industry, and references. Industry and research experts (multidisciplinary – MD, PharmD, and PhD) are editors and authors. An added CD-ROM (slides only) enhances utility and marketability of book to course directors, providing the highly sought after slides for lectures.
Описание: Informatics and robotics are the workhorses of a technological revolution in drug research. On them are based combinatorial chemistry, which yields compounds by the many thousands, and high-throughput bioassays, which screen them for activity. The results are avalanches of `hits`, which invade the databases like swarms of locusts.
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