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RegisterClass I BCS based biowaiver with different amounts of API between T and R [Dissolution / BCS / IVIVC]
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.
Regards
» 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.
Regards
—
Scopy
Scopy
Complete thread:
- Class I BCS based biowaiver with different amounts of API between T and R joosefupas 2018-11-08 11:00 [Dissolution / BCS / IVIVC]
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