RSABE… [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2021-02-24 14:46 (158 d 16:08 ago) – Posting: # 22228
Views: 1,207

Hi Loky do,

» Regarding AUC widening, is it applicable in both partially and fully replicate designs …

If the main condition for RSABE is fulfilled (high variabilty), yes. Contrary to jurisdictions applying ABEL, a clinical justification and assessment of ‘outliers’ is not required.
In RSABE you don’t ‘widen’ the limits. That’s a simplification. For the background see this post and the guidance you mentioned.

» … or fully replicate design only as FDA referred to the published book chapter for RSABE

Which book are you referring to?

» So could we apply it in general or it’s not applicable?

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.

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
21,596 posts in 4,516 threads, 1,532 registered users;
online 17 (0 registered, 17 guests [including 7 identified bots]).
Forum time: Monday 07:55 CEST (Europe/Vienna)

Imagine if every Thursday your shoes exploded
if you tied them the usual way.
This happens to us all the time with computers,
and nobody thinks of complaining.    Jef Raskin

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