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.