adjusted alpha for RSABE [RSABE / ABEL]
Dear Yura
Alpha is contained in the request to calculate 95% upper confidence limit of the linearized RSABE criterion. If you adjust alpha you have to calculate 1-alphaadj upper confidence limit. Looking at the SAS code change all
But as already said: Nobody knows or can calculate the value of alphaadj to use.
❝ So, is it right: for ABEL I should adjust Type I Error (alpha)
❝ or in other words to decrease to 0.025?
❝ What I can do if I’ll use RSABE
❝ (because here alpha is absent in formula)?
Alpha is contained in the request to calculate 95% upper confidence limit of the linearized RSABE criterion. If you adjust alpha you have to calculate 1-alphaadj upper confidence limit. Looking at the SAS code change all
alpha=0.1
to 2*alphaadj you will use.But as already said: Nobody knows or can calculate the value of alphaadj to use.
- Labes D, Schütz H. Inflation of Type I Error in the Evaluation of Scaled Average Bioequivalence, and a Method for its Control. Pharm Res. 2016;33(11):2805–14. doi:10.1007/s11095-016-2006-1. full-text view-only
- Davit et al. "Implementation of a Reference-Scaled Average Bioequivalence Approach for Highly Variable Generic Drug Products by the US Food and Drug Administration"
AAPS Journal, Vol. 14, No. 4, December 2012
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Regards,
Detlew
Regards,
Detlew
Complete thread:
- alpha for RSABE Yura 2017-03-29 10:31 [RSABE / ABEL]
- alpha for RSABE d_labes 2017-03-29 14:33
- alpha for RSABE Yura 2017-03-29 15:34
- adjusted alpha for RSABEd_labes 2017-03-29 16:23
- adjusted alpha for RSABE Yura 2017-03-31 14:05
- adjusted alpha for RSABEd_labes 2017-03-29 16:23
- alpha for RSABE Yura 2017-03-29 15:34
- alpha for RSABE d_labes 2017-03-29 14:33