ANVISA: scABEL TIE [RSABE / ABEL]

posted by d_labes  – Berlin, Germany, 2015-06-03 13:59 (3545 d 20:19 ago) – Posting: # 14899
Views: 9,518

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

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