Bioequivalence and Bioavailability Forum • Partial replicate design: ABE

Partial replicate design: ABE [Regulatives / Guidelines]

posted by Helmut – Vienna, Austria, 2024-06-27 10:00 (231 d 01:07 ago) – Posting: # 24041
Views: 1,263

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.

Note:

The FDA’s model is over-specified for the partial replicate design and might not converge → study done, no result. For details see this article.
The EMA prefers ‘Method A’ (all effects fixed) over ‘Method B’ (subjects random).

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz

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average bioequivalence Mahmoud 2024-06-24 11:29 [Regulatives / Guidelines]
- Partial replicate design: ABEHelmut 2024-06-27 08:00