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RegisterSample size calculation for R-SABE [RSABE / ABEL]
Hi everybody.
ANVISA (Brazil's regulatory agency) is now studying the possibility of accepting EMA's method for scaling the BE acceptance interval based on the variability of the reference medication. So we are struggling a little bit in the sample size calculation, since it is very new to us. We have always used PASS for sample size calculation, for the standard BE studies, and did not manage to reproduce the results of PowerTOST calculations for RSABE. Is a whole different calculus? For example, when I try to calculate a sample size for a full replicate crossover design (TRTR, RTRT) considering a true ratio of 0.95, a target power of 80% and a reference ISCV of 63%, in PASS I got 28 subjects (considering the equivalence limits of 69.84%–143.19%) and in PowerTOST I got 22 subjects.
Can you guys help me with that? Should I throw away my PASS?
Edit: Category changed. [Helmut]
ANVISA (Brazil's regulatory agency) is now studying the possibility of accepting EMA's method for scaling the BE acceptance interval based on the variability of the reference medication. So we are struggling a little bit in the sample size calculation, since it is very new to us. We have always used PASS for sample size calculation, for the standard BE studies, and did not manage to reproduce the results of PowerTOST calculations for RSABE. Is a whole different calculus? For example, when I try to calculate a sample size for a full replicate crossover design (TRTR, RTRT) considering a true ratio of 0.95, a target power of 80% and a reference ISCV of 63%, in PASS I got 28 subjects (considering the equivalence limits of 69.84%–143.19%) and in PowerTOST I got 22 subjects.
Can you guys help me with that? Should I throw away my PASS?
Edit: Category changed. [Helmut]
Complete thread:
- Sample size calculation for R-SABELucas 2014-02-07 11:41 [RSABE / ABEL]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- EMA’s ABEL Helmut 2014-02-07 14:21
- EMA’s ABEL Lucas 2014-02-07 16:49
- Carry-over Helmut 2014-02-07 17:12
- Carry-over Lucas 2014-02-07 17:42
- Carry-over Shuanghe 2014-02-10 17:11
- Carry-over Lucas 2014-02-07 17:42
- Carry-over Helmut 2014-02-07 17:12
- EMA’s ABEL Lucas 2014-02-07 16:49
- PowerTOST and Sample size estimation for R-SABE d_labes 2014-02-07 14:37
- PowerTOST and Sample size estimation for R-SABE kumarnaidu 2014-04-18 13:38
- PowerTOST and Sample size estimation for R-SABE Dr_Dan 2014-04-18 19:29
- PowerTOST and Sample size estimation for R-SABE kumarnaidu 2014-04-19 06:04
- PowerTOST and Sample size estimation for R-SABE Dr_Dan 2014-04-18 19:29
- PowerTOST and Sample size estimation for R-SABE Astea 2015-06-25 01:14
- Sample size for scABEL/RSABE vs. conventional ABE d_labes 2015-06-25 09:19
- PowerTOST and Sample size estimation for R-SABE mittyri 2015-06-25 10:43
- PowerTOST and Sample size estimation for R-SABE Astea 2015-06-25 13:54
- Scaled ABE d_labes 2015-06-25 14:04
- PowerTOST and Sample size estimation for R-SABE Astea 2015-06-25 13:54
- PowerTOST and Sample size estimation for R-SABE kumarnaidu 2014-04-18 13:38
- EMA’s ABEL Helmut 2014-02-07 14:21
Ing. Helmut Schütz