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RegisterPPIs sometimes highly variable even in fasted state [Design Issues]
posted by Helmut 
– Vienna, Austria, 2017-02-27 12:32 (2613 d 17:15 ago) – Posting: # 17113
Views: 5,864
Dear Dan and M.tareq,
Agree.
When it comes to PPIs I only partly agree. There are no safety concerns (in some contries some PPIs are even available OTC). Sometimes PPIs show a CVwR >30% even in fasted state. IMHO, I could make sense to design both studies in a replicate design – though the sample size could be different.
The partial replicate is lousy design (search the forum…). See this post why a 4-period full replicate is preferable over 3-period replicates.
❝ the design for the fed state study does not need to be the same as for the fasted study.
Agree.
❝ In fact it would be unethical to treat more subjects in the fasted study in a more elaborated design than you would need to demonstrate bioequivalence.
When it comes to PPIs I only partly agree. There are no safety concerns (in some contries some PPIs are even available OTC). Sometimes PPIs show a CVwR >30% even in fasted state. IMHO, I could make sense to design both studies in a replicate design – though the sample size could be different.
❝ ❝ i.e partial replicate ?
The partial replicate is lousy design (search the forum…). See this post why a 4-period full replicate is preferable over 3-period replicates.
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Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Complete thread:
- Fed VS Fast state in BE studies M.tareq 2017-02-26 09:34 [Design Issues]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Fed VS Fast state in BE studies Dr_Dan 2017-02-27 11:01
- PPIs sometimes highly variable even in fasted stateHelmut 2017-02-27 11:32
- PPIs sometimes highly variable even in fasted state DavidManteigas 2017-02-27 16:08
- Refuse-to-Receive Standards Helmut 2017-02-27 16:25
- Refuse-to-Receive Standards M.tareq 2017-03-17 13:11
- Refuse-to-Receive Standards nobody 2017-03-17 16:27
- Refuse-to-Receive Standards Helmut 2017-02-27 16:25
- PPIs sometimes highly variable even in fasted state DavidManteigas 2017-02-27 16:08
- PPIs sometimes highly variable even in fasted stateHelmut 2017-02-27 11:32
- Fed VS Fast state in BE studies Dr_Dan 2017-02-27 11:01
Ing. Helmut Schütz