Drug Metabolism in Drug Development: A DIA Tutorial for Regulatory Affairs Specialists

Abstract

Many drug metabolism, drug-drug interaction, and pharmacogenetics meetings are held each year and are well attended by scientists from the pharmaceutical industry, academia, and worldwide regulatory agencies. Personal communication indicated that large amounts of drug metabolism information passed across the desks of the regulatory affairs specialists either as reports being submitted to or as information requests from regulatory agencies and that, unlike other preclinical or clinical data, there was little appreciation of the meaning or relevance of such information to the overall drug development campaign. The purpose of the tutorial described here was to allow regulatory affairs specialists to gain a working appreciation of the nomenclature, techniques, and usefulness of in vitro and in vivo drug metabolism studies.

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Correspondence to Peter K. Honig MD, MPH.

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This tutorial was held in conjunction with the DIA 32nd Annual Meeting “The Challenge of Worldwide Pharmaceutical Development in an Era of Regulatory Change: Accelerated Approval with Quality and Contained Cost,” June 9–13, 1996, San Diego, California.

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Honig, P.K., Cantilena, L.R. & Santone, K.S. Drug Metabolism in Drug Development: A DIA Tutorial for Regulatory Affairs Specialists. Ther Innov Regul Sci 32, 163–167 (1998). https://doi.org/10.1177/009286159803200123

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Key Words

  • Metabolism
  • Cytochrome P450
  • Inhibition
  • Induction
  • Polymorphism