gsrao2022
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India,
2021-03-28 20:12
(23 d 00:55 ago)

Posting: # 22295
Views: 369
 

 BE study designing related doubts [Design Issues]

I have some doubts, could anyone help me out

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?


2). For replicate study design which should be preferred partial replicate or full replicate? which is preferred by regulatory?

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


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


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


Edit: Category changed; see also this post #1. Please follow the Forum’s Policy[Helmut]
Helmut
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Vienna, Austria,
2021-03-29 00:41
(22 d 20:27 ago)

@ gsrao2022
Posting: # 22296
Views: 312
 

 BE study designing related doubts

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.

Dif-tor heh smusma 🖖
Helmut Schütz
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