RSABE… [Regulatives / Guidelines]

posted by Loky do – Egypt, 2021-02-24 15:30 (281 d 19:45 ago) – Posting: # 22230
Views: 1,547

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:

Activity
 Admin contact
21,785 posts in 4,556 threads, 1,547 registered users;
online 7 (0 registered, 7 guests [including 3 identified bots]).
Forum time: Friday 11:15 CET (Europe/Vienna)

A drug is that substance which, when injected into a rat,
will produce a scientific report.    Anonymous

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