Scaling/Widening of AUC [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2021-03-16 13:55 (261 d 23:29 ago) – Posting: # 22271
Views: 1,291

Hi dshah,

» I am having few doubts for harmonization.

Welcome to the club!

» Why regulatory bodies does have different requirement for scaling acceptance …

IMHO, not related to science at all but to politics.
I attended all conferences of the ‘Global Bioequivalence Harmonization Initiative’ and was a member of the panel of the session ‘Scaling Procedure and Adaptive Design(s) in BE Assessment of Highly Variable Drugs’ (2nd GBHI, Rockville, September 2016). Justifications? Not really. I guess (‼):
» Or for NTI- limit of 90.00-111.11 is more relevant than RSABE approach and does justify the safety and efficacy?

Good question, next question.

Dif-tor heh smusma 🖖
Helmut Schütz
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