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RegisterBatch selection based on CDP [Dissolution / BCS / IVIVC]
Dear BE proff!
I believe there is no specific answer for your question. If drug is belonging to BCS class I/III- kindly follow the BCS based biowaiver guideline but for BCS II/IV- multiple factors can play a role.
The Reflection paper on the dissolution specification for generic solid oral immediate release products with systemic action by EMA can be useful for the choice in selecting media (emphasis on discrimination).
But the biorelvence can only be confirmed after the study outcome. F2 criteria alone are many times not useful.
The PIL can be useful for time point selection to capturing ADME but many times the Tmax, t1/2 can be slightly different in the research article.
Regards,
Divyen Shah
I believe there is no specific answer for your question. If drug is belonging to BCS class I/III- kindly follow the BCS based biowaiver guideline but for BCS II/IV- multiple factors can play a role.
The Reflection paper on the dissolution specification for generic solid oral immediate release products with systemic action by EMA can be useful for the choice in selecting media (emphasis on discrimination).
But the biorelvence can only be confirmed after the study outcome. F2 criteria alone are many times not useful.
The PIL can be useful for time point selection to capturing ADME but many times the Tmax, t1/2 can be slightly different in the research article.
Regards,
Divyen Shah
Complete thread:
- Batch selection based on CDP BE-proff 2022-02-24 06:25 [Dissolution / BCS / IVIVC]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Batch selection based on CDPdshah 2022-03-02 19:17
Ing. Helmut Schütz