Regulatory Consideration for Bioavailability (BA)/Bioequivalence (BE) Studies in Solid oral Dosage Forms (IR &MR) for Generic Application in Europe and USA

Abstract

Bioavailability (BA) and Bioequivalence (BE) studies play a chief function inside the drug development segment for each new drug products and their generic equivalents. Generic products should have same safety, efficacy and quality standards as that of the innovator products. BE is an approach to introduce generic version of innovator drugs to establish the therapeutic equivalency and interchangeability to decrease the value of drugs thru proper assessment as directed through the worldwide regulatory authorities. This project mainly focuses on the BA/BE requirements for the solid oral dosage forms for USA and EU countries which needs to be fulfill during the generic drug application submission. This comparison includes the bioequivalence approaches such as study design, sample size, study condition, pharmacokinetic parameters, statistical analysis, narrow therapeutic index drugs, highly variable drug products and BCS based bio waiver requirements. The rationale for this article is to give prompt overview on the bioequivalence requirements and comparison of USFDA and EMA. In addition, it also highlights the possibilities for harmonization. Keywords: USFDA, EMEA, Bioavailability, Bioequivalence, Pharmacokinetics