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Register12 = bad [Power / Sample Size]
posted by Helmut 
– Vienna, Austria, 2013-10-31 00:49 (4613 d 06:49 ago) – Posting: # 11827
Views: 9,472
Hi ElMaestro,
I found a goody from the 2008 AAPS Annual Meeting
I found a goody from the 2008 AAPS Annual Meeting
Gagné J-F, Shink É, Trabelsi F, and M Tanguay
Evaluation of the reliability associated with pilot bioequivalence studies
Poster W5317, online abstract
Simulations showed that given a 85% theoretical PE (bad formulation) and a sample-size of 12 subjects, the probability of detecting a bad formulation (observed PE outside 95%-105%) is ≥85% for all ISCVs tested.
However, given a theoretical ratio of 100% (good formulation), a sample-size of 12 subjects, and an ISCV of 20%, the probability of detecting a good formulation (observed PE within 95%-105%) is 48% only. This probability goes down to ≤30% for highly variable drugs.
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Dif-tor heh smusma 🖖🏼 Довге життя Україна!![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png)
Helmut Schütz
![[image]](https://static.bebac.at/img/CC by.png)
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
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:
- “Ideal” sample size of a pilot study? Helmut 2013-10-27 14:15
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- “Ideal” sample size of a pilot study? ElMaestro 2013-10-27 16:47
- “Ideal” sample size for TSDs’ n1? Helmut 2013-10-27 18:27
- “Ideal” sample size for TSDs’ n1? ElMaestro 2013-10-27 19:09
- “Ideal” sample size for TSDs’ n1? Helmut 2013-10-27 19:19
- “Ideal” sample size for TSDs’ n1? ElMaestro 2013-10-27 19:09
- Alpha? Helmut 2013-10-28 13:29
- 12 = badHelmut 2013-10-30 23:49
- “Ideal” sample size for TSDs’ n1? Helmut 2013-10-27 18:27
- “Ideal” sample size of a pilot study? ElMaestro 2013-10-27 16:47
Ing. Helmut Schütz