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.
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.
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.
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.
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