Bioequivalence and Bioavailability Forum • ANVISA: scABEL TIE

ANVISA: scABEL TIE [RSABE / ABEL]

posted by d_labes – Berlin, Germany, 2015-06-03 13:59 (3615 d 18:58 ago) – Posting: # 14899
Views: 9,653

Dear Helmut!

❝ Reading ANVISA’s response over and over again, I gather that they mean #1 in order to be on the safe side (“EMA accepts reference-scaling for five years now. Let’s be slightly more conservative.”). At least some of the inflation of the Type I Error observed with EMA’s “method” vanishes (I expect still a TIE of ~0.06 at 40%). Until Detlew releases an (experimental?) update for PowerTOST’s *.scABEL functions (regulator="ANVISA") one can only assume the worst in sample size estimation, i.e., unscaled ABE, theta0=0.9, CV=0.4…

PowerTOST V1.2-07 is on the way.
First impression concerning TIE (n=24, nsims=1E6):

    CV   theta0      TIE

 0.250  1.250000 0.050508

 0.275  1.250000 0.050839

 0.300  1.250000 0.053183

 0.325  1.250000 0.061220

 0.350  1.250000 0.078676

 0.375  1.250000 0.105438

 0.400  1.250000 0.137350

 0.4001 1.340322 0.039371

 0.425  1.363072 0.039987

 0.450  1.385991 0.038561

 0.475  1.408971 0.035537

 0.500  1.431997 0.031668

 0.525  1.431997 0.036341

 0.550  1.431997 0.040046

 0.575  1.431997 0.042868

 0.600  1.431997 0.044908

—
Regards,

Detlew

Complete thread:

ANVISA’s home brewed scaling? Helmut 2015-05-28 18:27 [RSABE / ABEL]
- ANVISA’s home brewed scaling? ElMaestro 2015-05-28 19:10
  - ANVISA: TIE, sample size Helmut 2015-06-02 16:00
    - ANVISA: scABEL TIEd_labes 2015-06-03 11:59
      - ANVISA: scABEL TIE Helmut 2015-06-03 12:07
        
        ANVISA: scABEL TIE part II d_labes 2015-06-03 13:19
        
        ANVISA: scABEL TIE part II nobody 2015-06-03 13:31
        
        ANVISA: scABEL TIE part II d_labes 2015-06-03 14:00
        
        ANVISA scABEL - sample size d_labes 2015-06-05 11:03
- ANVISA’s home brewed scaling? Lucas 2015-06-02 16:02
  - ANVISA’s home brewed scaling? Helmut 2015-06-02 16:16