Log in
RegisterOne-sided Confidence Limit for CV [Power / Sample Size]
Dear HS,
Thanks for your kind and prompt attention. I understand we cannot get a reliable estimate of the CV by using a small sample size i.e. 6 subjects; but using 16 subjects for a pilot BE is analogous to doing a full-scale BE.
What if the pilot BE using 16 indicates bioequivalence for the test product versus the reference product based on the 90% CI for Cmax and AUC - would this mean a full-scale BE is no longer needed?
Thanks for your kind and prompt attention. I understand we cannot get a reliable estimate of the CV by using a small sample size i.e. 6 subjects; but using 16 subjects for a pilot BE is analogous to doing a full-scale BE.
What if the pilot BE using 16 indicates bioequivalence for the test product versus the reference product based on the 90% CI for Cmax and AUC - would this mean a full-scale BE is no longer needed?
Complete thread:
- Sample size for a pilot BE joyjac 2006-05-18 08:13 [Power / Sample Size]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Confidence Interval for CV Helmut 2006-05-18 13:17
- One-sided Confidence Limit for CV Helmut 2006-05-18 14:36
- One-sided Confidence Limit for CVjoyjac 2006-05-19 01:22
- One-sided Confidence Limit for CV Helmut 2006-05-19 13:02
- BE demonstrated in pilot study H_Rotter 2006-05-20 13:56
- One-sided Confidence Limit for CVjoyjac 2006-05-19 01:22
- Confidence Interval for CV intuitivepharma 2013-05-06 12:31
- use PowerTOST Helmut 2013-05-06 13:09
- use PowerTOST intuitivepharma 2013-05-07 08:52
- use PowerTOST Helmut 2013-05-06 13:09
- One-sided Confidence Limit for CV Helmut 2006-05-18 14:36
- Confidence Interval for CV Helmut 2006-05-18 13:17
Ing. Helmut Schütz