Log in
RegisterPE consideration [Regulatives / Guidelines]
Dear Dan,
Can we use 10% formulation difference. I saw one CRO had calculated the sample size based on the mean ratio (T/R)=88% (from pilot study). Is it appropriate to consider this much difference. In FDA guidance "Statistical Approaches to Establishing Bioequivalence" they have written the below line in sample size consideration section.
Sample sizes for average BE should be obtained using published formulas. Sample sizes for population and individual BE should be based on simulated data. The simulations should be conducted using a default situation allowing the two formulations to vary as much as 5% in average BA with equal variances and certain magnitude of subject-by-formulation interaction. The study should have 80 or 90% power to conclude BE between these two formulations. Sample size also depends on the magnitude of variability and the design of the study. Variance estimates to determine the number of
subjects for a specific drug can be obtained from the biomedical literature and/or pilot studies.
Please guide me.
Can we use 10% formulation difference. I saw one CRO had calculated the sample size based on the mean ratio (T/R)=88% (from pilot study). Is it appropriate to consider this much difference. In FDA guidance "Statistical Approaches to Establishing Bioequivalence" they have written the below line in sample size consideration section.
Sample sizes for average BE should be obtained using published formulas. Sample sizes for population and individual BE should be based on simulated data. The simulations should be conducted using a default situation allowing the two formulations to vary as much as 5% in average BA with equal variances and certain magnitude of subject-by-formulation interaction. The study should have 80 or 90% power to conclude BE between these two formulations. Sample size also depends on the magnitude of variability and the design of the study. Variance estimates to determine the number of
subjects for a specific drug can be obtained from the biomedical literature and/or pilot studies.
Please guide me.
—
Kumar Naidu
Kumar Naidu
Complete thread:
- Sample size vasup 2013-07-29 08:37 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Sample size ElMaestro 2013-07-29 10:00
- Sample size jag009 2013-07-29 15:57
- Overpowering Helmut 2013-07-30 15:51
- Overpowering ElMaestro 2013-07-30 16:37
- Overpowering jag009 2013-07-30 16:45
- Overpowering ElMaestro 2013-07-30 16:51
- Overpowering jag009 2013-08-01 20:08
- Overpowering kumarnaidu 2013-09-02 12:22
- Conservative study planning Helmut 2013-09-02 12:42
- Conservative study planning kumarnaidu 2013-09-02 14:36
- Conservative study planning Ohlbe 2013-09-02 18:44
- confidence limit of the CV Jay 2013-09-06 13:55
- CL of CV Helmut 2013-09-06 15:02
- CL of CV Jay 2013-09-06 15:21
- CL of CV Helmut 2013-09-06 15:42
- PE consideration Jay 2013-09-11 11:02
- PE consideration Dr_Dan 2013-09-11 12:07
- PE consideration Jay 2013-09-11 13:09
- PE considerationkumarnaidu 2013-09-11 13:22
- Sockpuppet? Helmut 2013-09-11 14:13
- PE consideration kumarnaidu 2013-09-12 13:04
- PE consideration Dr_Dan 2013-09-11 12:07
- PE consideration Jay 2013-09-11 11:02
- CL of CV Helmut 2013-09-06 15:42
- CL of CV Jay 2013-09-06 15:21
- CL of CV Helmut 2013-09-06 15:02
- Conservative study planning kumarnaidu 2013-09-02 14:36
- Conservative study planning Helmut 2013-09-02 12:42
- Overpowering kumarnaidu 2013-09-02 12:22
- Overpowering jag009 2013-08-01 20:08
- Overpowering ElMaestro 2013-07-30 16:51
- Overpowering jag009 2013-07-30 16:45
- Overpowering ElMaestro 2013-07-30 16:37
Ing. Helmut Schütz