Postmarketing Surveillance



The fundamental importance of safety and efficacy assessment throughout the drug development process has been emphasized many times in previous chapters. These chapters have discussed “engineering safety” into new molecular entities, safety evaluations in nonclinical studies, and safety evaluations in clinical trials. Efficacy is also considered throughout the drug development process, particularly in the discovery phase and then again in therapeutic exploratory and confirmatory clinical trials. However, safety and efficacy assessments conducted and reported to regulatory agencies to request marketing approval have their limitations. As Olsson and Meyboom (2006) noted


Drug Development Process Active Surveillance System Drug Safety Information Standard Liver Function Test Confirmatory Clinical Trial 
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Further Readings

  1. Mann R, Andrews E, 2007, Pharmacovigilance, 2nd Edition. Hoboken, NJ: Wiley.Google Scholar
  2. Medicines and Healthcare Products Regulatory Agency (MHRA), 2009, Good Pharmacovigilance Practice Guide. London: Pharmaceutical Press.Google Scholar
  3. Strom BL, Kimmel SE, 2007, Textbook of Pharmacoepidemiology. Hoboken, NJ: Wiley.Google Scholar
  4. Waller P, 2010, An Introduction to Pharmacovigilance. Hoboken, NJ: Wiley-Blackwell.Google Scholar
  5. Campbell MJ, Machin D, 1999, Medical Statistics: A Commonsense Approach, 3rd Edition. Chichester, UK: Wiley.Google Scholar
  6. Olsson S, Meyboom R, 2006, Pharmacovigilance. In Mulder GJ, Dencker L (Eds), Pharmaceutical Toxicology. London: Pharmaceutical Press.Google Scholar

Copyright information

© Springer Science+Business Media, LLC 2011

Authors and Affiliations

  1. 1.Cardiac Safety Services QuintilesDurhamUSA

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