Scaling/Widening of AUC [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2021-03-16 13:55 (214 d 18:27 ago) – Posting: # 22271
Views: 1,184

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
[image]

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

Complete thread:

Activity
 Admin contact
21,730 posts in 4,544 threads, 1,543 registered users;
online 10 (0 registered, 10 guests [including 8 identified bots]).
Forum time: Sunday 09:22 CEST (Europe/Vienna)

Be very, very careful what you put into that head,
because you will never, ever get it out.    Thomas Wolsey

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5