average bioequivalence [Regulatives / Guidelines]

posted by Mahmoud  – Jordan, 2024-06-24 13:29 (23 d 13:22 ago) – Posting: # 24035
Views: 578

Dear All

For statitical anaylsis Semi-Replicated (TRR,RTR,RRT). Some pesrons do the followings:

model= Sequence Period Treatment Sequence*Treatment as fixed effects.

Random : Subject(Sequence) Treatment*Subject(Sequence).

CI for T/R ratio derived using Treatment*Subject(sequence) as the error term.


Is this true under FDA or EMA guidelines.

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