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RegisterANVISA: scABEL TIE part II [RSABE / ABEL]
Dear Helmut!
You are welcome. But wait until it arrives really.
Exactly.
But the picture changes if they claim the same hokus pokus like "consumer risk model" and "implementation" as in the paper
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
p(BE) at the original EMA widened acceptance limits, again n=24, design="2x3x3" (partial replicate), nsims=1E6:
❝ ❝ PowerTOST V1.2-07 is on the way.
❝ THX!
You are welcome. But wait until it arrives really.
❝ ❝ First impression concerning TIE (n=24, nsims=1E6):
❝ ❝ CV theta0 TIE
❝ ❝ 0.400 1.250000 0.137350
❝
❝ Terrible! In their attempt to be more conservative they are shooting themselves in the foot. The same story over and over again. 
Exactly.
But the picture changes if they claim the same hokus pokus like "consumer risk model" and "implementation" as in the paper
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
p(BE) at the original EMA widened acceptance limits, again n=24, design="2x3x3" (partial replicate), nsims=1E6:
CV theta0 p(BE)
0.2500 1.250000 0.050508
0.2750 1.250000 0.050839
0.3000 1.250000 0.053183
0.3250 1.272300 0.039390
0.3500 1.294796 0.036086
0.3750 1.317424 0.037143
0.4000 1.340165 0.039410
0.4001 1.340256 0.039408
0.4250 1.363001 0.040021
0.4500 1.385915 0.038601
0.4750 1.408890 0.035578
0.5000 1.431910 0.031708
0.5250 1.431910 0.036390
0.5500 1.431910 0.040094
0.5750 1.431910 0.042911
0.6000 1.431910 0.044961—
Regards,
Detlew
Regards,
Detlew
Complete thread:
- ANVISA’s home brewed scaling? Helmut 2015-05-28 18:27
![[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 IId_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 size d_labes 2015-06-05 11:03
- ANVISA: scABEL TIE part IId_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