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RegisterHC: Sample size for AUC and Cmax: exact and sim’s [Power / Sample Size]
Dear zizou,
Dear Helmut,
Thank you very much! At first I though that RStudio got frozen :)
Sorry for not responding earlier, notification has not worked.
In the meantime, Canadian CRO just used Intra-subject variability of AUCt (very low) with extreme T/R to justify the sample size of 24. And we have reasons to assume that real T/R for Cmax is far below unity. This gives less than 60% power on 24 subjects, but still more than just a coin flip
And almost no one will want to run bioequivalence study on hundreds of subjects...
Regards, VStus
Dear Helmut,
Thank you very much! At first I though that RStudio got frozen :)
Sorry for not responding earlier, notification has not worked.
In the meantime, Canadian CRO just used Intra-subject variability of AUCt (very low) with extreme T/R to justify the sample size of 24. And we have reasons to assume that real T/R for Cmax is far below unity. This gives less than 60% power on 24 subjects, but still more than just a coin flip
And almost no one will want to run bioequivalence study on hundreds of subjects...Regards, VStus
Complete thread:
- Canada: Sample size for Cmax? Helmut 2012-12-18 18:04
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Canada: IUT violated? d_labes 2012-12-19 14:00
- Canada: IUT violated? Helmut 2012-12-29 15:59
- IUT d_labes 2012-12-31 13:36
- Canada: IUT violated? Helmut 2012-12-29 15:59
- Canada: Sample size for Cmax: R-code? VStus 2017-01-19 10:10
- Canada: Sample size for Cmax: R-code? zizou 2017-01-19 12:20
- HC: Sample size for AUC and Cmax: exact and sim’s Helmut 2017-01-19 12:30
- HC: Sample size for AUC and Cmax: exact and sim’sVStus 2017-01-31 13:44
- Canada: IUT violated? d_labes 2012-12-19 14:00
Ing. Helmut Schütz