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RegisterANVISA scABEL - sample size [RSABE / ABEL]
Dear Helmut! Dear All!
Proud to announce:
.
After fiddling with such ugly requests like "Title case".
First look on sample size:
Settings: design="2x3x3", theta0=0.9 (acc. to the two Laszlo's), targetpower=0.8
As you see there is a partly considerable rise in burden for the ANVISA settings compared to the EMA in the range CV=30 - 45%(!). In this range ANVISA is actually more conservative than EMA. Note the range CV=40-45% where the widened acceptance ranges are identical for both regulatory settings but sample size is higher for ANVISA.
After reaching the CV where a cap has to be placed on the widening (CV=50%) of the acceptance range both regulatory settings give the same sample size needed.
Proud to announce:
PowerTOST V1.2-07 is on CRAN now .After fiddling with such ugly requests like "Title case".
First look on sample size:
Settings: design="2x3x3", theta0=0.9 (acc. to the two Laszlo's), targetpower=0.8
CV N(EMA) N(ANVISA)
-----------------------
0.25 42 42
0.275 48 51
0.3 54 60
0.325 51 69
0.35 48 78
0.375 45 78
0.4 42 63
0.425 42 51
0.45 39 45
0.475 39 42
0.5 39 42
0.525 42 42
0.55 42 42
0.575 45 45
0.6 48 48
0.65 54 54
0.7 60 60
0.8 75 75As you see there is a partly considerable rise in burden for the ANVISA settings compared to the EMA in the range CV=30 - 45%(!). In this range ANVISA is actually more conservative than EMA. Note the range CV=40-45% where the widened acceptance ranges are identical for both regulatory settings but sample size is higher for ANVISA.
After reaching the CV where a cap has to be placed on the widening (CV=50%) of the acceptance range both regulatory settings give the same sample size needed.
—
Regards,
Detlew
Regards,
Detlew
Complete thread:
- ANVISA’s home brewed scaling? Helmut 2015-05-28 18:27 [RSABE / ABEL]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- ANVISA’s home brewed scaling? ElMaestro 2015-05-28 19:10
- ANVISA: TIE, sample size Helmut 2015-06-02 16:00
- ANVISA: scABEL TIE d_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 TIE part II nobody 2015-06-03 13:31
- ANVISA scABEL - sample sized_labes 2015-06-05 11:03
- ANVISA: scABEL TIE part II d_labes 2015-06-03 13:19
- ANVISA: scABEL TIE Helmut 2015-06-03 12:07
- ANVISA: scABEL TIE d_labes 2015-06-03 11:59
- ANVISA: TIE, sample size Helmut 2015-06-02 16:00
- ANVISA’s home brewed scaling? Lucas 2015-06-02 16:02
- ANVISA’s home brewed scaling? Helmut 2015-06-02 16:16
- ANVISA’s home brewed scaling? ElMaestro 2015-05-28 19:10
Ing. Helmut Schütz