Fundamentals of Biologicals Regulation

  • Author : Rebecca Sheets
  • Publsiher : Academic Press
  • Release : 13 December 2017
  • ISBN : 9780128094433
  • Page : 450 pages
  • Rating : 4/5 from 21 voters

Download or read online book entitled Fundamentals of Biologicals Regulation written by Rebecca Sheets and published by Academic Press. This book was released on 13 December 2017 with total page 450 pages. Available in PDF, EPUB and Kindle. Get best books that you want by click Get Book Button and Read as many books as you like. Book Excerpt : 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

Fundamentals of Biologicals Regulation

Fundamentals of Biologicals Regulation
Author: Rebecca Sheets
Publisher: Academic Press
Relase: 2017-12-13
ISBN: 9780128094433
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Fundamentals of Pharmaceutical and Biologics Regulations Third Edition

Fundamentals of Pharmaceutical and Biologics Regulations  Third Edition
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Fundamentals of International Pharmaceutical and Biologics Regulations
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Fundamentals of US Pharmaceutical and Biologics Regulations

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Fundamentals of Canadian Pharmaceutical and Biologics Regulations

Fundamentals of Canadian Pharmaceutical and Biologics Regulations
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Fundamentals of International Pharmaceutical and Biologics Regulations

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Fundamentals of Canadian Pharmaceutical Biologic and Medical Device Regulations

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Fundamentals of Law and Regulation An in depth look at therapeutic products

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Global Pharmaceutical and Biologics Regulation

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Global Pharmaceutical and Biologics Regulation

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Fundamentals of Clinical Trials

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Fundamentals of US Regulatory Affairs

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Author: Syed Rizwanuddin Ahmad,Cassie Alexander,Berry Berger,Mitchell Berger,Peggy Berry,Charles Breen,David Brindley,Fernando Henrique X. de Brito,Elizabeth Campbell,Kell Canon,Carol Cooper,Pallavi Sharma Das,Sunny Kamlesh Dave,Seameen Dehdashti,Cindy DiBiasi,Jim DiBiasi,Joy Frestedt,Abhishek Gurnani,Robert Guzman,Michael Hinckle,Karen Jaffe,Jocelyn Jennings,Angela Johnnson,Kurt Karst,Allison Komiyama,Mona Koshkouei,Carrie Kuehn,Evangeline Loh,Demetra Macheras,Robert Martin,Nancy Mathewson,Kirsten Messmer,Bernard Naughton,Tina O'Brien,Valerie Ramsey,Sarah Robinson,Joanne Rupprecht,Alexandra Beumer Sassi,Kathrin Scalper,Charity-Anne Schuller,Kandarp Shah,William Sietsema,Andrew Slade,James Smith,Edward Steele,Ashhish Talati,Nancy Teague,Snehal Trivedi,Gresham Weatherly,Martha Wells,Jennifer Wilhelm,Holly Winchell,Linda Yang
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The Fundamentals of Life Sciences Law

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Relase: 2007
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