Bioequivalence review for drug interchangeability.
To monitor the performance of the approved generic copies of a brand-name drug, we propose some methods in assessing bioequivalence among generic copies and the brand-name drug, and among generic copies themselves, using data from several bioequivalence studies adopting the standard 2 x 2 crossover design without carryover effects. We propose a meta-analysis method that increases statistical power when the between-subject variability is not large. A nonmeta-analysis is also considered. A numerical example of applying both methods is presented for illustration.
Chow
S C
SC
StatPlus, Inc., Yardley, Pennsylvania 19067, USA.
Shao
J
J
D019540:Area Under Curve; D001699:Biometry / Q000379:methods*; D018592:Cross-Over Studies; D016568:Drugs, Generic / Q000493:pharmacokinetics* / Q000592:standards; D006801:Humans; D008432:Mathematical Computing; D015201:Meta-Analysis as Topic; D015233:Models, Statistical; D012015:Reference Standards; D013810:Therapeutic Equivalency
D016568:Drugs, Generic