Bioequivalence and Bioavailability Forum

Mahmoud ★ Jordan, 2024-06-24 13:29 (719 d 21:19 ago) Posting: # 24035 Views: 4,009	average bioequivalence [Regulatives / Guidelines] Post reply
	Dear All For statitical anaylsis Semi-Replicated (TRR,RTR,RRT). Some pesrons do the followings: model= Sequence Period Treatment SequenceTreatment as fixed effects. Random : Subject(Sequence) TreatmentSubject(Sequence). CI for T/R ratio derived using Treatment*Subject(sequence) as the error term. Is this true under FDA or EMA guidelines.

Helmut
★★★

Vienna, Austria,
2024-06-27 10:00
(717 d 00:48 ago)

@ Mahmoud
Posting: # 24041
Views: 3,007

Partial replicate design: ABE

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).

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Helmut Schütz

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