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RegisterPost hoc power & other things… [Design Issues]
posted by Helmut 
– Vienna, Austria, 2013-02-22 15:15 (4873 d 05:16 ago) – Posting: # 10107
Views: 7,960
Dear Ken!
Fantastic! Another example where a GL mandates nonsense. However, I cannot find a requirement that post hoc power has to be ≥80%. So, report it based on the study’s T/R-ratio and CVintra in order to make BPFK happy. If they reject a study which has demonstrated BE (CI within acceptance range) based on power <80% consider going to court.
Section 9.4 contains another stupidity: Summary of statistical significance for AUC and Cmax.
In BE we accept 20% as clinically irrelevant. If a study has high power (most likely if the CV is low and/or the T/R-ratio is close to 100%) we might get a statistically significant difference. Again, reporting this outcome is nonsense. See this thread and especially this example.
See this post. The help-system will give you all the necessary steps. At the end of each page you find examples. If you are interested in the statistical background see
❝ ❝ Post hoc power is completely irrelevant in bioequivalence. Either you demonstrated BE or not. Full 
. Unfortunately the Malaysian authority asks for post hoc power sometimes (or always?). It’s time for them to learn. 
❝
❝ Yes, it is a requirement. Please refer to Guidelines on Bioequivalence, 7.Bioequivalence Reporting Format (under 9.4) http://portal.bpfk.gov.my/index.cfm?&menuid=122.
Fantastic! Another example where a GL mandates nonsense. However, I cannot find a requirement that post hoc power has to be ≥80%. So, report it based on the study’s T/R-ratio and CVintra in order to make BPFK happy. If they reject a study which has demonstrated BE (CI within acceptance range) based on power <80% consider going to court.
Section 9.4 contains another stupidity: Summary of statistical significance for AUC and Cmax.
In BE we accept 20% as clinically irrelevant. If a study has high power (most likely if the CV is low and/or the T/R-ratio is close to 100%) we might get a statistically significant difference. Again, reporting this outcome is nonsense. See this thread and especially this example.
❝ Where can we learn how to run PowerTOST ? Please advise.
See this post. The help-system will give you all the necessary steps. At the end of each page you find examples. If you are interested in the statistical background see
BE_power_sample_size_excerpt.pdf in the folder PowerTOST/doc.—
Dif-tor heh smusma 🖖🏼 Довге життя Україна!![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png)
Helmut Schütz
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The quality of responses received is directly proportional to the quality of the question asked. 🚮
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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:
- Trifluoperazine Ken Peh 2013-02-16 16:26 [Design Issues]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Trifluoperazine drgunasakaran1 2013-02-17 08:53
- Trifluoperazine Ken Peh 2013-02-18 07:28
- Pilot or Two-Stage Helmut 2013-02-18 13:53
- Pilot or Two-Stage Ken Peh 2013-02-18 18:19
- Pilot or Two-Stage Helmut 2013-02-19 13:37
- Pilot or Two-Stage Ken Peh 2013-02-20 03:34
- Post hoc power & other things… Helmut 2013-02-20 20:11
- Post hoc power & other things… Ken Peh 2013-02-22 08:17
- Post hoc power & other things…Helmut 2013-02-22 14:15
- Post hoc power & other things… Ken Peh 2013-02-24 09:08
- estimation ≠ calculation Helmut 2013-02-24 17:09
- Post hoc power & other things… Ken Peh 2013-02-24 09:08
- Post hoc power & other things…Helmut 2013-02-22 14:15
- Post hoc power & other things… Ken Peh 2013-02-22 08:17
- Post hoc power & other things… Helmut 2013-02-20 20:11
- Pilot or Two-Stage Ken Peh 2013-02-20 03:34
- Pilot or Two-Stage Helmut 2013-02-19 13:37
- Pilot or Two-Stage Ken Peh 2013-02-18 18:19
- Pilot or Two-Stage Helmut 2013-02-18 13:53
- Trifluoperazine Ken Peh 2013-02-18 07:28
- Trifluoperazine drgunasakaran1 2013-02-17 08:53
Ing. Helmut Schütz