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 书籍 Fundamentals of Pharmaceutical and Biologics Regulations: A Global Perspective, Second Edition |
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Second Edition
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In today’s complex global regulatory landscape, critical information is often scattered across articles, chapters, and multiple languages, making it difficult to find clear, reliable guidance in one place. This fully updated second edition brings together that knowledge into a single, authoritative resource for regulatory professionals worldwide. Building on the success of the first edition, this new release features 36 chapters, including expanded and updated content reflecting evolving global regulations. Developed by 61 expert authors and two lead editors, it offers a collaborative, global perspective you can trust. New and expanded content addresses key emerging areas, including: Acute and Chronic Toxicity Assessments Local Tolerance Studies Core Labeling as a Global Tool Combination Products 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. |
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(2025-6-4)
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