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RegisterExample for discussion [Power / Sample Size]
Dear Detlew, Dear Helmut,
Let me play the devil’s advocate.
Let's say you have to register some new generic pharmaceutical product and you have the data of pilot study which says that GMR is about 115% with CV about 20% (n=20). The ISCV data is mainly in accordance with literature sources (18-26%).
Again, a man in Harmani suite as your Boss says it MUST be registered and you have only current product to test. So you are interested to register the drug (to show the bioeqivalence).
What would be your recommendation for sample size? How would you estimate it?
Let me play the devil’s advocate.
Let's say you have to register some new generic pharmaceutical product and you have the data of pilot study which says that GMR is about 115% with CV about 20% (n=20). The ISCV data is mainly in accordance with literature sources (18-26%).
Again, a man in Harmani suite as your Boss says it MUST be registered and you have only current product to test. So you are interested to register the drug (to show the bioeqivalence).
What would be your recommendation for sample size? How would you estimate it?
—
Kind regards,
Mittyri
Kind regards,
Mittyri
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–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–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 discussionmittyri 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 discussionmittyri 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