Mahmoud
★    

Jordan,
2024-06-24 13:29
(233 d 22:40 ago)

Posting: # 24035
Views: 1,775
 

 average 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.
Helmut
★★★
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Homepage
Vienna, Austria,
2024-06-27 10:00
(231 d 02:09 ago)

@ Mahmoud
Posting: # 24041
Views: 1,265
 

 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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