Bioequivalence Guidelines Requirements for Orally Administered Generics (IR Products) in Gulf Cooperation Council Countries, European Union and United States of America

Abstract

The importance of the bioequivalence requirements is increasing in the GCC (Gulf Cooperation Council) region pertaining towards the growth of generic drug market. GCC bioequivalence guidelines describes the requirements for bioequivalence study as per this region regulatory requirements. This review article mainly focuses on bioequivalence study requirements in the Gulf Cooperation Council countries, European union countries and the United States of America that needs to be fulfilled in order to successfully submit a generic application. 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 in these region and in comparison with well-established regulatory such as USFDA and EMA. In addition, it also highlights the possibilities for harmonization.