The Indian Pharmacopoeia Commission (IPC) has successfully participated and concluded World Health Organisation (WHO) Biowaiver Project for Biopharmaceutics Classification System (BCS) based classification of active pharmaceutical ingredients (APIs).
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The WHO Biowaiver Project classified first set of APIs like tenofovir, dolutegravir, ethionamide and the outcome was finally endorsed by the WHO 53rd Expert Committee on submission.
Further to this, WHO Expert Committee prioritized the second set of APIs (N=15) to scale up the project for BCS based classification. IPC has participated in the WHO Biowaiver Project by contributing in the equilibrium solubility experiments on APIs and results have been communicated to the WHO for compilation of report.
There are certain requirements for a biowaiver study that include allowance of regulatory authorities like the respective Food and Drug Administration (FDA) and WHO. The drugs should have high solubility and high permeability according to BCS. BCS is an experimental model that measures permeability and solubility under prescribed conditions.
A Biowaiver means that in vivo bioavailability and/or bioequivalence studies may be waived (not considered necessary for product approval). Instead of conducting expensive and time consuming in vivo studies, a dissolution test could be adopted as the surrogate basis for the decision as to whether the two pharmaceutical products are equivalent.
BCS is a regulatory mechanism through which drug developers and generic companies can obtain a waiver of clinical bioequivalence (BE) studies, also called a biowaiver. While BE establishes generic drugs as interchangeable to the branded ones with similar therapeutic and side effect profiles, bioavailability (BA) of drugs signifies the rate and extent to which their active ingredient is absorbed systemically after dosing.
The risk of therapeutic inequivalence of two immediate release products can never be reduced to zero, even if a full clinical study is performed. The conclusion of comparative clinical studies, in vivo bioequivalence studies, in vitro equivalence tests and biowaivers is based on statistics and scientific data that are assumed to be representative for the products at issue. The aim of biowaiver guidance is to reduce the risk of bioinequivalence to an acceptable level.
Pharmaceutical development work aims at reducing the probability of manufacturing inequivalent formulations taking into account the critical aspects of the product at issue. In this context, the absorption phase is regarded as the critical process determining the equivalence of the pharmacokinetic profiles and thereby the therapeutic equivalence of the test and reference product.
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