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Statistics and the Drug Development Process

  • Bruce Rodda
  • Steven P. Millard
  • Andreas Krause
Chapter

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 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

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References

1.7.1 Print References

  1. Drews, Jürgen. (1999). In Quest of Tomorrow’s Medicines. Springer-Verlag, New York.Google Scholar
  2. Guarino, R.A. (1987). New Drug Approval Process: Clinical and Regulatory Management. Marcel Dekker, New York.Google Scholar
  3. Johnson, J. (1987). Past and present regulatory aspects of drug development. In: Peace, K., ed., Biopharmaceutical Statistics for Drug Development. Marcel Dekker, New York, Chap. 1.Google Scholar
  4. Mathieu, M. (1990). New Drug Development: A Regulatory Overview. PAREXEL International Corp., Waltham, MA.Google Scholar
  5. Mathieu, M. (1997). Biologics Development: A Regulatory Overview. PAREXEL International Corp., Waltham, MA.Google Scholar
  6. Peace, K., ed. (1987). Biopharmaceutical Statistics for Drug Development. Marcel Dekker, New York.Google Scholar

1.7.2 Electronic References

  1. http://www.fda.gov/ U.S. Food and Drug Administration
  2. http://www.emea.eu.int/ European Agency for the Evaluation of Medicinal Products
  3. http://www.fda.gov/fdac/special/newdrug/benlaw.html Evolution of U.S. drug law, including the Kefauver—Harris amendment
  4. http://www.mcclurenet.com/ Provides the ICH guidelines
  5. http://www.ifpma.org/ichl.html Official website for the ICH
  6. http://clinicaltrials.gov/ct/gui/c/w2b/ NIH website on clinical trialsGoogle Scholar

Copyright information

© Springer Science+Business Media New York 2001

Authors and Affiliations

  • Bruce Rodda
    • 1
  • Steven P. Millard
    • 2
  • Andreas Krause
    • 3
  1. 1.Southwest Texas State UniversitySan MarcosUSA
  2. 2.Probability, Statistics & InformationSeattleUSA
  3. 3.Novartis Pharma AGBaselSwitzerland

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