ANVISA’s home brewed scaling? [RSABE / ABEL]
Hi Lucas,
THX for clarifying!
Technically no problem. See EMA’s SAS-code given for the “crippled models” (Methods A and B) in the Q&A-document. If the reference’s CV is not >40%, use the conventional acceptance range. Of course this leads to the weird discontinuity at 40%:
Absolutely – THX!
❝ […] the first approach described by HS up here is the one that they want. Same regulatory constant.
THX for clarifying!
❝ […] but how would that be used together with EMA's ABEL I wouldn't know how.
Technically no problem. See EMA’s SAS-code given for the “crippled models” (Methods A and B) in the Q&A-document. If the reference’s CV is not >40%, use the conventional acceptance range. Of course this leads to the weird discontinuity at 40%:
CVWR sWR L ~ U
0.400000 0.385253 80.00~125.00
0.400001 0.385254 74.62~134.02
❝ Hope to have been of help.
Absolutely – THX!
—
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Helmut Schütz
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Dif-tor heh smusma 🖖🏼 Довге життя Україна!
![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png)
Helmut Schütz
![[image]](https://static.bebac.at/img/CC by.png)
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
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 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 size d_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