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Registerα and 1–β [Power / Sample Size]
posted by Helmut 
– Vienna, Austria, 2017-12-27 12:57 (1069 d 14:39 ago) – Posting: # 18099
Views: 27,907
Hi Yura,
» If at GMR=0.95 and CV=0.25 calculation has to be carried out at N = 28-30 subjects, and you carry out on 50 subjects, there can be questions on forced bioequivalence
If I got your example correctly, 28–30 subjects mean 81–83% power. In some guidelines 80–90% power are recommended. 90% power would require 38 subjects. 50 subjects would mean 96% power (BE-proff’s “big wallet”).
However, such a sample size should concern only the IEC (assessing the risk for the study participants). If the protocol was approved by the IEC and the competent regulatory agency, performed as planned and by chance show an even higher “power”, an eyebrow of the assessor might be raised but technically (Type I Error is controlled) there is no reason to question the study.
» If at GMR=0.95 and CV=0.25 calculation has to be carried out at N = 28-30 subjects, and you carry out on 50 subjects, there can be questions on forced bioequivalence
If I got your example correctly, 28–30 subjects mean 81–83% power. In some guidelines 80–90% power are recommended. 90% power would require 38 subjects. 50 subjects would mean 96% power (BE-proff’s “big wallet”).
However, such a sample size should concern only the IEC (assessing the risk for the study participants). If the protocol was approved by the IEC and the competent regulatory agency, performed as planned and by chance show an even higher “power”, an eyebrow of the assessor might be raised but technically (Type I Error is controlled) there is no reason to question the study.
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Helmut Schütz
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Dif-tor heh smusma 🖖
Helmut Schütz
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Complete thread:
- Power is getting high kms.srinivas 2017-12-26 07:39 [Power / Sample Size]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Power is getting high? d_labes 2017-12-26 12:08
- Stop estimating post hoc power! Helmut 2017-12-26 12:22
- Stop estimating post hoc power! kms.srinivas 2017-12-26 13:00
- Stop estimating post hoc power! ElMaestro 2017-12-26 14:11
- Simulations Helmut 2017-12-26 15:51
- Simulations BE-proff 2017-12-27 06:53
- Simulations ElMaestro 2017-12-27 07:25
- Simulations Yura 2017-12-27 08:23
- Simulations kms.srinivas 2017-12-27 09:11
- Simulations Yura 2017-12-27 10:07
- α and 1–βHelmut 2017-12-27 12:57
- α and 1–β Yura 2017-12-27 13:33
- α and 1–β Helmut 2017-12-27 14:31
- α and 1–β Yura 2017-12-28 06:50
- Educate the IEC and regulators Helmut 2017-12-28 11:30
- α and 1–β Yura 2017-12-28 06:50
- α and 1–β Helmut 2017-12-27 14:31
- α and 1–β Yura 2017-12-27 13:33
- α and 1–βHelmut 2017-12-27 12:57
- “Forced BE” 101 Helmut 2017-12-27 12:23
- “Forced BE” 101 kms.srinivas 2017-12-27 12:41
- Would you be so kind answering our questions? Helmut 2017-12-27 13:02
- Would you be so kind answering our questions? kms.srinivas 2017-12-28 05:53
- Yes, but why? Helmut 2017-12-28 11:47
- Yes, but why? DavidManteigas 2017-12-28 16:59
- Optimists and pessimists Helmut 2017-12-28 17:33
- "normal" GMR setting d_labes 2017-12-28 18:57
- Example for discussion mittyri 2017-12-28 22:06
- Example for discussion Helmut 2017-12-28 22:33
- I prefer to play it safe Helmut 2017-12-28 22:10
- Example for discussion mittyri 2017-12-28 22:06
- "normal" GMR setting d_labes 2017-12-28 18:57
- Full ACK d_labes 2017-12-28 17:41
- About GMR 1.10 kms.srinivas 2017-12-29 13:20
- Better 0.95 or 0.90 Helmut 2017-12-29 16:18
- Optimists and pessimists Helmut 2017-12-28 17:33
- Yes, but why? Yura 2017-12-29 13:46
- Buffon's needle Astea 2018-01-20 23:55
- Buffon's needle Oleg777 2018-10-09 22:48
- 0.95 or 1.05 Helmut 2018-10-10 13:41
- Buffon's needle Helmut 2018-10-10 12:46
- Buffon's needle Astea 2018-10-11 23:14
- School maths Helmut 2018-10-12 01:10
- School russian Astea 2018-10-12 12:41
- Offtop: Umschrift der westlichen Eigennamen auf Russisch mittyri 2018-10-12 23:25
- School maths Helmut 2018-10-12 01:10
- Buffon's needle Astea 2018-10-11 23:14
- Buffon's needle Oleg777 2018-10-09 22:48
- Yes, but why? DavidManteigas 2017-12-28 16:59
- Yes, but why? Helmut 2017-12-28 11:47
- EEU? mittyri 2017-12-28 21:52
- EEU? Yura 2017-12-29 13:41
- EEU - pharmacokinetic equation??? mittyri 2017-12-29 14:11
- EEU? Beholder 2018-01-16 15:10
- EEU? Yura 2017-12-29 13:41
- Would you be so kind answering our questions? kms.srinivas 2017-12-28 05:53
- Would you be so kind answering our questions? Helmut 2017-12-27 13:02
- “Forced BE” 101 kms.srinivas 2017-12-27 12:41
- Simulations Yura 2017-12-27 10:07
- Simulations kms.srinivas 2017-12-27 09:11
- Simulations xtianbadillo 2018-01-18 22:22
- Simulations BE-proff 2017-12-27 06:53
- Stop estimating post hoc power! kms.srinivas 2017-12-26 13:00
- Numbers don't lie ElMaestro 2017-12-28 20:13
Ing. Helmut Schütz