Statistics and the Drug Development Process

Bruce Rodda, Steven P. Millard and Andreas Krause
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Bruce Rodda: Southwest Texas State University
Steven P. Millard: Probability, Statistics & Information
Andreas Krause: Novartis Pharma AG

Chapter 1 in Applied Statistics in the Pharmaceutical Industry, 2001, pp 3-14 from Springer

Abstract: Abstract This introductory chapter begins with a brief history of the drug development process and the evolution of statistics and statisticians in that process. This is followed by a more detailed summary of the various elements that comprise the discovery, development, approval, and manufacture of new therapeutic entities.

Keywords: Drug Development; Drug Development Process; Animal Toxicology; Premarketing Approval; Regulatory Overview (search for similar items in EconPapers)
Date: 2001
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Persistent link: https://EconPapers.repec.org/RePEc:spr:sprchp:978-1-4757-3466-9_1

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DOI: 10.1007/978-1-4757-3466-9_1

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