Автор: Ira R. Berry and Robert P. Martin Название: The Pharmaceutical Regulatory Process, 2nd Edition Издательство: CRC Press Год: 2008 ISBN: 978-1420070422 Серия: Drugs and the Pharmaceutical Sciences (Book 185) Язык: English Формат: pdf Размер: 11,1 mb Страниц: 650
This book focuses on major legislative revisions that impact requirements for drug safety reviews, product regulatory approvals, and marketing practices. Written by top industry professionals, practicing attorneys, and FDA regulators, it includes policies and procedures that pharmaceutical companies need to implement regulatory compliance post-approval.
New chapters cover:
the marketing of unapproved new drugs and FDA efforts to keep them in regulatory compliance pharmacovigilance programs designed to prevent widespread safety issues legal issues surrounding the sourcing of foreign APIs the issues of counterfeit drugs updates on quality standards
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;...
Excipient Toxicity and Safety Автор: Myra L. Weiner and Lois A. Kotkoskie Название: Excipient Toxicity and Safety Издательство: CRC Press Год: 1999 ISBN: 9780824782108; 0824782100...
New Drug Approval Process Автор: Richard A Guarino Название: New Drug Approval Process Издательство: CRC Press Год: 1999 Серия: Drugs and the Pharmaceutical Sciences (Book...
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The Pharmaceutical Regulatory Process, 2nd Edition 
