Bioequivalence and Bioavailability Forum

Dear Dr_Dan,

Thanks for your response.

❝ Applying for a BCS-based biowaiver is restricted to highly soluble drug substances with known human absorption (BCS class I&III).

Yes.

❝ In case of simvastatin you will not be able to determine the formulation effect unless you have performed a BE study.

Main aim of the BE study is to compare the rate and extent of absorption. However in this particular test, drug efficacy is not correlated with plasma concentration as evident from no change in efficacy upon increase in plasma concentration in one reported drug intercation study. Also drug is not getting accumulated in the body so no risk of drug build up upon chronic dosing and no safety issue. Absorption is constatnt over the dose range for smaller particles and also the excipients in the formulation are similar/do not affect GI motility and hence no difference than innovator in rate of absorption can be sought.

Please suggest.

Regards,
PJS