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Registerα and 1–β [Power / Sample Size]
Hi Helmut,
You are considering the power after the study at n = 28 (which were calculated before the study: GMR=0.95, CV=0.25, β=0.80). The question is whether it is possible to carry out a study at n = 50 and will this be forced bioequivalence?
Regards
❝ Although the study was performed with 28 subjects for ~81% power, the chance to get a post hoc power of ≥ 90% is ~23% and ≥ 95% is ~10%. That’s clearly not “forced BE” and none of these studies should be questioned by regulators.
You are considering the power after the study at n = 28 (which were calculated before the study: GMR=0.95, CV=0.25, β=0.80). The question is whether it is possible to carry out a study at n = 50 and will this be forced bioequivalence?
Regards
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–β Helmut 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–βYura 2017-12-28 06:50
- Educate the IEC and regulators Helmut 2017-12-28 11:30
- α and 1–βYura 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–β Helmut 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