RSABE… [Regulatives / Guidelines]

posted by Loky do – Egypt, 2021-02-24 16:30 (1376 d 01:55 ago) – Posting: # 22230
Views: 3,690

Hi Dear Helmut,

Many thanks for your reply :-D:-D

❝ Which book are you referring to?


❝ For the FDA you can apply RSABE for any PK metric (AUCs, partial AUCs, Cmax, :blahblah:) if its \(\small{s_{\textrm{wR}}\geq 0.294\;(CV_{\textrm{wR}}\geq\approx0.300469\ldots)}\)

❝ If \(\small{s_{\textrm{wR}}<0.294}\) you have to evaluate the respective PK metric for ABE.


I didn't find this statement in FDA guidance for bioequivalence studies just in progesterone guidance so, is it enough to refer to this guide while submitting the study to regulatory (as the intrasubject variability CV% equal 57%, partially replicate design), or is there another guide would support this way? please advice?

Thanks in advance

Complete thread:

UA Flag
Activity
 Admin contact
23,328 posts in 4,898 threads, 1,662 registered users;
79 visitors (0 registered, 79 guests [including 17 identified bots]).
Forum time: 18:26 CET (Europe/Vienna)

Satisfaction of one’s curiosity is one of the greatest sources
of happiness in life.    Linus Pauling

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