Planning-stage checklist, not a formal biowaiver justification. This applies the real, published WHO/ICH M9 BCS-based biowaiver criteria as a deterministic checklist -- it does not verify your underlying dissolution/solubility/permeability data, and a real biowaiver submission requires that full data package plus current regulatory affairs review. FDA, EMA, WHO, and national authorities (including India's CDSCO) may apply these criteria with some differences -- confirm exact current requirements for your target market. See also Complex Generics & 505(b)(2) Pathway Planner and Global Regulatory Strategy.
Product & Data Inputs
Permeability is documented as high (>=85% absorbed, or bioavailability otherwise demonstrated complete) via mass-balance/absolute-bioavailability literature data.
Both test and reference dissolve >=85% within 30 minutes in pH 1.2, 4.5, AND 6.8 media (BCS I criterion).
Both test and reference dissolve >=85% within 15 minutes in pH 1.2, 4.5, AND 6.8 media (stricter BCS III criterion).
Excipients are qualitatively and quantitatively similar to the reference product, using only well-characterized excipients in normal-use amounts (required for BCS III).
This is a narrow therapeutic index drug (e.g. digoxin, warfarin, levothyroxine, phenytoin, lithium-class).
There are known bioavailability problems for this drug/class.
Eligibility Result
Enter the product data and run the check to see the criterion-by-criterion breakdown.