Bioequivalence testing to be made compulsory for capecitabine generics

Local drug manufacturers who intend to obtain the product license for a generic version of capecitabine will be required to conduct bioequivalence testing instead of comparative dissolution test, according to the Korea Food and Drug Administration.

A KFDA official said that the safety and efficacy of capecitabine generic should be evaluated through bioequivalence testing, since the bioequiva...