kishor
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2010-08-03 08:12
(5807 d 02:46 ago)

Posting: # 5709
Views: 5,096
 

 F1 and F2 values [Dissolution / BCS / IVIVC]

Dear,

Can any one tell me basics of F1 and F2 values and its significance in BE study? Is it compulsory that F2 values should be matching to reference and test formulation?
What will be the assay range for Reference & Test?


In advance thanks
Regards,
Kishor
Helmut
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2010-08-03 17:36
(5806 d 17:21 ago)

@ kishor
Posting: # 5710
Views: 4,132
 

 F1 and F2 values

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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