F1 and F2 values [Dissolution / BCS / IVIVC]

posted by Helmut Homepage – Vienna, Austria, 2010-08-03 17:36 (5807 d 20:27 ago) – Posting: # 5710
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Dear Kishor!

❝ Can any one tell me basics of F1 and F2 values and its significance in BE study?


See this post and the given references.

❝ Is it compulsory that F2 values should be matching to reference and test formulation?


No. Any in vitro method is just a surrogate of in vivo bioequivalence. f2 <50 does not invalidate proven BE.

❝ What will be the assay range for Reference & Test?


I don't get your point. Can you please try to reword it?

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