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Fundamentals of Biologicals Regulation: Vaccines and Biotechnology Medicines

Amazon.com Price: $100.00 (as of 12/05/2019 16:48 PST- Details)

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Fundamentals of Biologicals Regulation: Vaccines and Biotechnology Medicines serves as an introduction to the international regulatory arena through which biologicals are developed and offers an overview of the processes and insight into the scientific concepts underpinning global regulations. This book will provide more than one levels of readership with guidance on basic concepts, a detailed have a look at regulatory challenges, and practical insight into how regulators imagine regulatory science and regulatory process issues across quite a lot of regions. With a lot of case studies, learning activities, and real-world examples across a few 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 bear in mind why they’re different
Contains chapters on one of the most exceptions to the process including how biosimilars and in vitro diagnostics are regulated
Includes a lot of case studies, learning activities, and real-world examples across a few classes of biotechnological products

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