BE study designing related doubts [Design Issues]

posted by Helmut Homepage – Vienna, Austria, 2021-03-29 00:41 (19 d 06:55 ago) – Posting: # 22296
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Hi gsrao,

» 1). If any molecule intra subject CV of Cmax is less than 30 and for AUC more than 30. in this case can we go for replicate design for EU regulatory?

A replicate design is always accepted.

» 2). For replicate study design which should be preferred partial replicate or full replicate?

From a statistical perspective, a full replicate is preferred. When you are concerned about dropouts or the bioanalytical method requires large sample volumes, opt for one the 2-sequence 3-period designs (TRT|RTR or TRR|RTT).

» which is preferred by regulatory?

Any one is fine. If you opt for a 2-sequence 3-period design you need at least 12 eligible subjects in the sequence where R is repeated (see the Q&A document). That’s not relevant in practice unless you face an extreme dropout-rate (see this post).

» 3). What is the maximum half life to go for Parallel study?

No fixed rules.

» 4). What is the minimum days of wash out period required (in days) for eg. if a molecule half-life is 1 hour?

In days, really? With 1/10 you are on the safe side. :-D
Never plan based on an average. The shortest washout I ever had were three days.

» 5). If a study passes 90 % CI, but the power is below 80 does regulatory approves the study?

Post hoc (a posteriori, retrospective) power is completely irrelevant. Stop calculating it. Stop reporting it. If any agency has – stupid – questions, hire me. See also there.

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Helmut Schütz
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