Fundamentals of Biologicals Regulation

Vaccines and Biotechnology Medicines

Nonfiction, Health & Well Being, Medical, Specialties, Preventive Medicine, Medical Science, Immunology
Cover of the book Fundamentals of Biologicals Regulation by Rebecca Sheets, PhD, CAPT (Retired), USPHS, Elsevier Science
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Author: Rebecca Sheets, PhD, CAPT (Retired), USPHS ISBN: 9780128094433
Publisher: Elsevier Science Publication: December 1, 2017
Imprint: Academic Press Language: English
Author: Rebecca Sheets, PhD, CAPT (Retired), USPHS
ISBN: 9780128094433
Publisher: Elsevier Science
Publication: December 1, 2017
Imprint: Academic Press
Language: English

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
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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.

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