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Two drug products containing the same drug substance(s) are considered bioequivalent if their bioavailabilities (rate and extent of drug absorption) after administration in the same molar dose lie
within acceptable predefined limits. These limits are set to ensure comparable in vivo performance, i.e.,
similarity in terms of safety and efficacy. In in vivo bioequivalence studies, the pivotal
pharmacokinetic parameters AUC (area under the concentration time curve) and Cmax (maximum
concentration), are generally used to assess the rate and extent of drug absorption.
The BCS (Biopharmaceutics Classification System)-based biowaiver approach is intended to reduce
the need for in vivo bioequivalence studies i.e., it can provide a surrogate for in vivo bioequivalence. In
vivo bioequivalence studies may be exempted if an assumption of equivalence in in vivo performance
can be justified by satisfactory in vitro data. The BCS is a scientific approach based on the aqueous
solubility and intestinal permeability characteristics of the drug substance(s). The BCS categorizes
drug substances into one of four BCS classes as follows:
Class I: high solubility, high permeability
Class II: low solubility, high permeability
Class III: high solubility, low permeability
Class IV: low solubility, low permeability
This guidance provides recommendations to support the biopharmaceutics classification of drug
substances and the BCS-based biowaiver of bioequivalence studies for drug products. The BCS-based
biowaiver principles may be applied to bioequivalence purposes not explicitly specified in the
guideline, provided they can be supported by a thorough scientific rationale.
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