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Fundamentals of Biologicals Regulation : Vaccines and Biotechnology Medicines (Paperback) (Rebecca

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About this item

Fundamentals of Biologicals Regulation: Vaccines and Biotechnology Medicines serves as an introduction to the international regulatory arena in which biologicals are developed and offers an overview of the processes and insight into the scientific concepts underpinning global regulations. This book will provide multiple levels of readership with guidance on basic concepts, a detailed look at regulatory challenges, and practical insight into how regulators consider regulatory science and regulatory process issues across various regions. With numerous case studies, learning activities, and real-world examples across several classes of biotechnological products, this book is a valuable and comprehensive resource for graduate students, professors, regulatory officials, and industry scientists working with biologicals.

  • Provides a broad overview and introduction to the regulatory processes, from product development pathways, through clinical trials and product development stages and beyond
  • Includes FDA, EMA, ICH, and WHO recommendations and guidelines so readers can compare and contrast the different regulatory regions with their expectations and understand why they are different
  • Contains chapters on some of the exceptions to the process including how biosimilars and in vitro diagnostics are regulated
  • Includes numerous case studies, learning activities, and real-world examples across several classes of biotechnological products
Number of Pages: 450
Genre: Medical
Format: Paperback
Publisher: Elsevier Science Ltd
Author: Rebecca Sheets
Language: English
Street Date: December 1, 2017
TCIN: 51960887
UPC: 9780128092903
Item Number (DPCI): 248-37-4844
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