Re: Gender as a covariate
From ETTEE@cder.fda.gov Sat Jun 14 12:43:42 1997
Subject: Re: Gender as a covariate
I think that there is an over generalization on the issue of gender as covariate. It is worth noting that there may still be a gender effect on clearance (CL) after adjustment has been made for weight. This has been observed with some drugs. Omitting a gender effect (when present) because adjustment for weight has been made may have serious consequences. With data visualization, is a useful tool for informative population modeling, this error can be avoided.
Ene Ette, Ph.D.
Pharmacometrics Staff
Office of Clinical Pharmacology & Biopharmaceutics
FDA