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portada Fundamentals of Biologicals Regulation. Vaccines and Biotechnology Medicines
Type
Physical Book
Publisher
Author
Year
2026
Language
English
Pages
450
Format
Paperback
Dimensions
23.50 x 19.10 cm
ISBN13
9780443219887

Fundamentals of Biologicals Regulation. Vaccines and Biotechnology Medicines

Christopher Hamlin;Susan Neadle;Rebecca Sheets;Mehmet, Phd Tosun;Mark Schenerman;Kathryn C. Zoon;Ivana , Department Of Essential Medicines And Health Products, Switzerland) Knezevic (Author) · Academic Press Inc · Paperback

Fundamentals of Biologicals Regulation. Vaccines and Biotechnology Medicines - Christopher Hamlin;Susan Neadle;Rebecca Sheets;Mehmet, PhD Tosun;Mark Schenerman;Kathryn C. Zoon;Ivana , Department of Essential Medicines and Health Products, Switzerland) Knezevic

New Book Imported to Austria
Delivery: 02 Sep - 07 Sep Shipping: 11 to 13 business days.
167,41 €
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Synopsis "Fundamentals of Biologicals Regulation. Vaccines and Biotechnology Medicines"

Fundamentals of Biologicals Regulation: Vaccines and Biotechnology Medicines, Second Edition serves as an introduction to the international regulatory arena in which biologicals are developed, offering an overview of processes and insights into the scientific concepts underpinning global regulations. The book provides in-depth coverage of Quality by Design, Combination Products, Quality Target Product Profiles, Risk Management Plans, REMS, and switching from reliance on in vivo to in vitro analytical methods. It reflects new developments and processes accelerated by the COVID-19 vaccine experience, including emergency use authorizations and conditional marking authorizations. New pedagogic elements and case studies have been added to improve learning outcomes. This book provides multiple levels of readership, with guidance on basic concepts, a detailed look at regulatory challenges, and practical insights into how regulators consider regulatory science and regulatory process issues across various regions, with an emphasis on the European Medicines Agency and the U.S. Food and Drug Administration.

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