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

posted by Obinoscopy  – USA, 2018-11-10 07:25 (843 d 01:04 ago) – Posting: # 19560
Views: 1,719

Hi Joose,

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

No I don't think so. This is because they are not pharmaceutically equivalent.

This is even stated on the draft ICH M9 Guideline that you referenced. It can be found on lines 121 - 124 where eligibility for BCS based Biowaivers was discussed. Here's the excerpt:

A drug product is eligible for a BCS-based biowaiver provided that the drug substance(s) satisfy the criteria regarding solubility and permeability (BCS Class I and III), the drug product is an immediate-release oral dosage form with systemic action, and the drug product is a dosage form that is pharmaceutically equivalent to the reference product

For two products to be pharmaceutically equivalent, they must be of the same amount. I think some regulatory authorities allow a difference of 5% in the amount. But for 100% difference, no way.

The route you can go would be multiple strength biowaiver. However you have to check that the excipients are in the same proportion with the actives.



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