SFDA updated their Biowaiver guideline recently. These guidelines are intended to facilitate and support the workflow of drug registration and in order to provide a recommendation for the applicant to answer their concerns.
What is New in version no. 2.0?
Update on Solubility: Description of change
A drug substance is considered highly soluble when the highest single dose (in mg) is soluble in 250 ml or less of aqueous media over the pH range of 1.2-6.8.
The BCS (Biopharmaceutics Classification System)-based biowaiver approach is meant to reduce in-vivo bioequivalence studies, i.e., it may represent a surrogate for in-vivo bioequivalence. Invivo bioequivalence studies may be exempted if an assumption of equivalence in-vivo performance can be justified by satisfactory in-vitro data.
Applying for a BCS-based biowaiver is restricted to highly soluble drug substances with known human absorption and is considered not to have a narrow therapeutic index.
The concept is applicable to immediate release, solid pharmaceutical products for oral administration, and systemic action having the same pharmaceutical form. However, it is not applicable for sublingual, buccal, and modified release formulations.
BCS-based biowaivers are intended to address the question of bioequivalence between specific test and reference products.
Click this LINK to gain more details regarding this guideline.
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