An Overview on Bioequivalence Regulatory Requirements of Pharmaceutical Products: India and Gulf Cooperation Council States - (Gulf Cooperation Council Guidelines)

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DOI: 10.21522/TIJCR.2014.SE.19.01.Art001

Authors : Joseph William Wadakkan


Generic pharmaceutical products need to comply the same standards of quality, efficacy and safety as required of the innovator product. Generic drug market is expected to rise in coming future. Specifically, the Generic product should be therapeutically equivalent and interchangeable with the reference product. Present study highlights the regulatory guidelines for conduct of bioequivalence in India and the Gulf Cooperation Council States.

There is no international harmonization of regulatory requirements for bioequivalence, however, bioequivalence range and statistical analysis are to some extent harmonized, but there are differences in selection of subjects, food effect, application of multiple dose study, in vitro dissolution study, reference product etc.

In bioequivalence studies, the plasma concentration time curve is generally to assess the rate and extent of absorption. Selected pharmacokinetic parameters and preset acceptance limits allow the final decision on bioequivalence of the tested products. (AUC) the area under the concentration time curve reflects the extent of exposure. (C max) the maximum plasma concentration or peak exposure, and the time to maximum plasma concentration, (t max) are parameters that are influenced by absorption rate.

Bioequivalence study is one of the main requirements for generic drug approval process. This review provides an easy and quick overview for regulatory consideration required for bioequivalence study in those regions. In this paper includes information about important aspects of bioequivalence study design and specifications guidelines of each parameters also have been addressed.

Keywords: Bioequivalence, Bioavailability, Pharmacokinetics, GCC (Gulf Cooperation Council).


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