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RegisterSample size for scABEL/RSABE vs. conventional ABE [RSABE / ABEL]
Dear Astea!
I can't retrace why you are shocked that the sample size for scABEL is much lower than that of conventional average bioequivalence (ABE).
Quote from the paper of the two László's *:
"Both EMA and FDA developed the approaches for highly variable drugs in order to reduce the regulatory burden, i.e. to lower the required number of subjects in BE studies. The sample size tables in the Appendix demonstrate that both authorities achieve this goal."
Your computations verify that statement
.
BTW: Your statement that no more than 40 subjects are needed is only valid in your investigated CV range. CV=0.8 (80%) gives for your settings n=50.
For the FDA recommended method (RSABE) and regulatory settings the sample sizes are even lower.
I can't retrace why you are shocked that the sample size for scABEL is much lower than that of conventional average bioequivalence (ABE).
Quote from the paper of the two László's *:
"Both EMA and FDA developed the approaches for highly variable drugs in order to reduce the regulatory burden, i.e. to lower the required number of subjects in BE studies. The sample size tables in the Appendix demonstrate that both authorities achieve this goal."
Your computations verify that statement
.BTW: Your statement that no more than 40 subjects are needed is only valid in your investigated CV range. CV=0.8 (80%) gives for your settings n=50.
For the FDA recommended method (RSABE) and regulatory settings the sample sizes are even lower.
- László Tóthfalusi and László Endrényi
Sample Sizes for Designing Bioequivalence Studies for Highly Variable Drugs
J Pharm Pharmaceut Sci 15(1) 73 - 84, 2011
—
Regards,
Detlew
Regards,
Detlew
Complete thread:
- Sample size calculation for R-SABE Lucas 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 ABEd_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