Class I BCS based biowaiver with different amounts of API between T and R [Dissolution / BCS / IVIVC]

posted by joosefupas – Italy, 2018-11-08 11:00 (844 d 17:52 ago) – Posting: # 19548
Views: 2,082

Hello everyone,

I have already googled around the web but couldn't find any answers thus I'll see if anyone can help here!

ICH M9 draft guidance states that “BCS-based biowaivers are applicable to drug products where the drug substance(s) (thus APIs) in test and reference products are identical (e.g. same salt, ester, isomer or mixture of isomers from that in the reference product).

My question now is, what about different API doses/amount between test and reference though?
More specifically our test product contains the exact double amount of APIs (both BCS Class I drugs) of the reference product (1000/130mg of paracetamol/caffeine TEST vs 500/65mg REFERENCE).

Given the API amount difference between T and R do you think a BCS based biowaiver application would still be applicable?

Thanks a lot in advance for the great support


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