Truncated AUC [NCA / SHAM]

posted by Rajinikanth.S – India, 2024-03-20 09:41 (61 d 20:21 ago) – Posting: # 23912
Views: 955

Dear All,

If a subject(s) misses the last sampling point or few sampling time points before the 72 hours for a Treatment(s) then the AUC0-72/48/96 etc. hours parameter will be excluded for that Treatment(s) for that subject(s). If study involves measuring multiple analytes, the concept would be applied only to relevant analyte which is responsible for truncating the sample collection to 72 hours. Whenever there is no possibility to compare both Test and Reference formulations for AUC0-72 [e.g.: the issue of missing sample(s) exists in one of the Treatment(s) only], AUC0-72 of such subject(s) will be excluded for both treatments from the pharmacokinetic analysis and this scenario is mostly applicable for two way cross-over design.

Is it reliable statement, Plz confirm.

Edit: Category changed and subject line changed; see also this post #1 and #2[Helmut]

Complete thread:

UA Flag
 Admin contact
23,033 posts in 4,835 threads, 1,647 registered users;
43 visitors (0 registered, 43 guests [including 6 identified bots]).
Forum time: 07:02 CEST (Europe/Vienna)

Give me a fruitful error any time, full of seeds, bursting with its own corrections.
You can keep your sterile truth for yourself.    Vilfredo Pareto

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