ANVISA’s home brewed scaling? [RSABE / ABEL]

posted by Helmut Homepage – Vienna, Austria, 2015-06-02 18:16 (3539 d 13:15 ago) – Posting: # 14898
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Hi Lucas,

❝ […] 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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