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The Conduct of In Vitro and In Vivo Drug‐Drug Interaction Studies: A PhRMA Perspective
Author(s) -
Bjornsson Thorir D.,
Callaghan John T.,
Einolf Heidi J.,
Fischer Volker,
Gan Lawrence,
Grimm Scott,
Kao John,
King S. Peter,
Miwa Gerald,
Ni Lan,
Kumar Gondi,
McLeod James,
Obach Scott R.,
Roberts Stanley,
Roe Amy,
Shah Anita,
Snikeris Fred,
Sullivan John T.,
Tweedie Donald,
Vega Jose M.,
Walsh John,
Wrighton Steven A.
Publication year - 2003
Publication title -
the journal of clinical pharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.92
H-Index - 116
eISSN - 1552-4604
pISSN - 0091-2700
DOI - 10.1177/0091270003252519
Subject(s) - pharmacology , drug , in vivo , pharmaceutical industry , drug development , drug interaction , medicine , business , biology , microbiology and biotechnology
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 (CYP) probe substrates, inhibitors, and inducers and for the development of classification systems to improve the communication of risk to health care providers and patients. While existing guidances cover mainly CYP‐mediated drug interactions, the importance of other mechanisms, such as transporters, has been recognized more recently and should also be addressed. This paper was prepared by the Pharmaceutical Research and Manufacturers of America (PhRMA) Drug Metabolism and Clinical Pharmacology 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.