Article
The conduct of in vitro and in vivo drug-drug interaction studies: a PhRMA perspective.
Journal of clinical pharmacology - 1 May 2003
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
Abstract excerpt
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...
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