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Bioequivalence global requirements harmonization, importance and applicability
5th International Conference and Exhibition on Pharmaceutics & Novel Drug Delivery Systems
March 16-18, 2015 Crowne Plaza, Dubai, UAE
Saleh A Alsuwayeh
Posters & Accepted Abstracts: Pharm Anal Acta
Abstract:
Since majority of drug regulation deals with registration of generic drug products and the fact that bioequivalence studies are essential part of the registration dossier. This presentation aims to discuss importance of bioequivalence global requirements harmonization with respect to different parts of bioequivalence study namely; study protocol and documentation, clinical part, bioanalytical methods and statistical methods. In addition, shortcoming and impact of not having harmonized bioequivalence requirements on pharmaceutical industry will be discussed. The presentation will be concluded by discussing applicability of the bioequivalence global requirements harmonization on the regional level as well as the global level.