partial AUCs in SD [NCA / SHAM]

posted by Helmut Homepage – Vienna, Austria, 2021-08-02 16:05 (969 d 19:07 ago) – Posting: # 22497
Views: 2,424

Hi Vishal,

❝ as per your suggestion the partial AUCs will be AUC(0-12 hrs) & AUC12-24 hrs (Considering dosing interval of 24 hrs)


Yep. See my reply to Relaxation’s post.

❝ what happen if we select partial AUCs ie AUC(0-12 hrs) & AUC12-72 hrs (Considering last sample collection time point ie 72 hrs) & prove the bioequivalence is this accepted by regulatory?


I’m not an assessor. :-D
If you have no missings, a sufficient LLOQ (all late concentrations measurable), and if the assessor is a ‘tick-the-box type’ (since \(\small{_\textrm{partial}AUC_{\textrm{cut off}-t_\textrm{last}}}\) is stated in the GL), all is good.
However, from a PK perspective (‼) it doesn’t make sense.

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
22,957 posts in 4,819 threads, 1,636 registered users;
118 visitors (0 registered, 118 guests [including 8 identified bots]).
Forum time: 10:12 CET (Europe/Vienna)

With four parameters I can fit an elephant,
and with five I can make him wiggle his trunk.    John von Neumann

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