(470 d 22:02 ago)
Posting: # 22803
Let's say I am planning a BE-study and wanna select the best medications batches to have higher chances for success.
I have the following data:
1) dissolution results (graphs, tables) in required pHs
2) general PK-data taken from PIL: Tmax and T1/2
3) pharmaceutical form is immediate release tablet
4) F2 can be present or not
Is there any algorithm which allows to select the best batches using data listed above?
(464 d 09:10 ago)
Posting: # 22819
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.