Partial replicate design: ABE [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2024-06-27 10:00 (20 d 18:53 ago) – Posting: # 24041
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Hi Mahmoud,

❝ 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.

No. For the FDA’s model see here and for the EMA’s there.


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