Pharmacodynamics and Pharmacokinetics : Understanding Pharmacokinetics and Pharmacodynamics: Sex-Related Differences
The current body of knowledge about sex-specific drug effects and their clinical implications is small. A review of 300 new drug applications (NDAs) received by the FDA between 1994 and 2000 showed that 163 provided sex-based pharmacokinetic information and 39 provided sex-based pharmacodynamic information. The 163 pharmacokinetic analyses were derived from limited data from small subject groups (< 12 subjects). Only 2 of the 163 original NDA submissions included effects of the menstrual cycle on pharmacokinetics.3
Large sex differences in drug metabolism were discovered in animals as early as 1932 in a study that found that male rats have higher levels than female rats of the cytochrome P450 isozyme CYP3A. However, a similar sex difference has not been found in humans.
