Fundamentals of biologicals regulation : vaccines and biotechnology medicines

Sheets, Rebecca, author
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Publication Details Click to collapse Cite/Export

  • Creator Rebecca Sheets
  • Format Books
  • Publication London, United Kingdom : Academic Press, [2018] ©2018
  • Physical Details
    • xxvi, 421 pages : illustrations ; 24 cm
  • ISBNs 9780128092903, 0128092904
  • OCLC ocn960844990


  • 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.


  • Includes bibliographical references and index.