The conduct of in vitro and in vivo drug-drug interaction studies: A Pharmaceutical Research and Manufacturers of America (PhRMA) perspective

Thorir D. Bjornsson, John T. Callaghan, Heidi J. Einolf, Volker Fischer, Lawrence Gan, Scott Grimm, John Kao, S. Peter King, Gerald Miwa, Lan Ni, Gondi Kumar, James McLeod, R. Scott Obach, Stanley Roberts, Amy Roe, Anita Shah, Fred Snikeris, John T. Sullivan, Donald Tweedie, Jose M. VegaJohn Walsh, Steven A. Wrighton

Research output: Contribution to journalReview articlepeer-review

639 Scopus citations

Abstract

Current regulatory guidances do not address specific study designs for in vitro and in vivo drug-drug interaction studies. There is a common desire by regulatory authorities and by industry sponsors to harmonize approaches, to allow for a better assessment of the significance of findings across different studies and drugs. There is also a growing consensus for the standardization of cytochrome P450 (P450) probe substrates, inhibitors and inducers and for the development of classification systems to improve the communication of risk to health care providers and to patients. While existing guidances cover mainly P450-mediated drug interactions, the importance of other mechanisms, such as transporters, has been recognized more recently, and should also be addressed. This article was prepared by the Pharmaceutical Research and Manufacturers of America (PhRMA) Technical Working Groups and represents the current industry position. The intent is to define a minimal best practice for in vitro and in vivo pharmacokinetic drug-drug interaction studies targeted to development (not discovery support) and to define a data package that can be expected by regulatory agencies in compound registration dossiers.

Original languageEnglish (US)
Pages (from-to)815-832
Number of pages18
JournalDrug Metabolism and Disposition
Volume31
Issue number7
DOIs
StatePublished - Jul 1 2003

ASJC Scopus subject areas

  • Pharmacology
  • Pharmaceutical Science

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