Modernization of Bioequivalence Standards for Generic Products

Bioequivalence (BE)/ bioavailability(BA) studies play a major role in drug development both for new drug and their generic equivalents, these studies are also done before the approval of drug (post approval period) and are expressed in systemic exposure measures, such as Area under plasma Concentration-Time curve(AUC) and maximum concentration C-max these measures are assumed to relate with safety and efficacy out comes that may expressed by biomarkers. This (BA), (BE) studies provide important information in overall set of data that ensures the safety and effectiveness to the practitioners and patients.


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