Fundamentals of Biologicals Regulation —— Vaccines and Biotechnology Medicines

----- 基础生物制剂规定:疫苗和生物技术药物

ISBN: 9780128092903 出版年：2017 页码：452 Sheets, Rebecca Academic Press_RM

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 beyondIncludes 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 differentContains chapters on some of the exceptions to the process including how biosimilars and in vitro diagnostics are regulatedIncludes numerous case studies, learning activities, and real-world examples across several classes of biotechnological products