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书籍 Fundamentals of Pharmaceutical and Biologics Regulations: A Global Perspective, Second Edition |
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Published by RAPS © 2026. Hardcover. 666 pages. ISBN (print): 978-1-947493-96-4. ISBN (digital): 978-1-947493-97-1. Library of Congress Control Number: 2025948938. This second edition brings together expert insights to help you navigate an increasingly complex regulatory landscape with confidence. Table of Contents Section I: General Information Section II: Nonclinical Studies Section III: Chemistry, Manufacturing, and Controls Section IV: Clinical Trials Section V: Marketing Authorization Section VI: Postmarketing Authorization Linda McBride, RPh, RAC-US and Siegfried Schmitt, PhD, editors |
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(2025-6-4)