Active Pharmaceutical Ingredients: Development, Manufacturing, and Regulation, 2nd EditionКНИГИ » ЗДОРОВЬЕ И МЕДИЦИНА
Автор: Stanley Nusim Название: Active Pharmaceutical Ingredients: Development, Manufacturing, and Regulation, 2nd Edition Издательство: CRC Press Год: 2010 ISBN: 9781439803363 Серия: Drugs and the Pharmaceutical Sciences (Book 205) Язык: English Формат: pdf Размер: 24,2 mb Страниц: 456
This second edition is not only update what had been written earlier but also to add more definitive information on areas that require further emphasis and to expand the scope of the publication to include areas of significant importance to APIs. It has added a full chapter on biological manufacturing as well as sterile bulk manufacturing that remains a critical part of the field.
This second edition focuses on the quality control regulations for APIs that have been added or amended since the first edition. These updates help ensure that pharmaceutical professionals and drug manufacturers meet the established and required guidelines set forth by the United States and international regulatory agencies.
New Drug Approval Process, 5th Edition Автор: Richard A. Guarino and Richard Guarino Название: New Drug Approval Process, 5th Edition Издательство: CRC Press Год: 2009 ISBN: 9781420088496;...
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Active Pharmaceutical Ingredients: Development, Manufacturing, and Regulation, 2nd Edition 
