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Registeraverage bioequivalence [Regulatives / Guidelines]
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.
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.
Complete thread:
- average bioequivalenceMahmoud 2024-06-24 11:29 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Partial replicate design: ABE Helmut 2024-06-27 08:00
Ing. Helmut Schütz