RSABE… [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2021-02-24 14:46 (579 d 08:21 ago) – Posting: # 22228
Views: 2,111

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 🖖 Довге життя Україна! [image]
Helmut Schütz
[image]

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

Complete thread:

UA Flag
Activity
 Admin contact
22,390 posts in 4,685 threads, 1,594 registered users;
online 4 (0 registered, 4 guests [including 4 identified bots]).
Forum time: Tuesday 00:08 CEST (Europe/Vienna)

Statistics. A sort of elementary form of mathematics which consists of
adding things together and occasionally squaring them.    Stephen Senn

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