What types of reaction phenotyping studies are suggested by the US FDA?
The US FDA recommends that at least two of three methods be performed to identify the specific enzyme(s) responsible for a drug’s metabolism: 1) use of specific chemical inhibitors or antibodies that act as specific chemical inhibitors; 2) use of individual human recombinant CYP enzymes; or 3) correlation analysis using human liver microsomes prepared from individual donors’ livers and characterized for CYP activity.
