truncated design [Regulatives / Guidelines]

posted by Mahesh M – India, 2015-12-29 12:21 (3012 d 12:38 ago) – Posting: # 15769
Views: 10,244

Dear All,

For truncated design (AUC truncated to 72 hours) is it required to take additional samples 72.00 hrs onwards to identified intra subject variability of AUC0-∞ or regulatory agency accept PK data up to 72.00 hrs.?

Regards

Complete thread:

UA Flag
Activity
 Admin contact
22,957 posts in 4,819 threads, 1,636 registered users;
86 visitors (0 registered, 86 guests [including 12 identified bots]).
Forum time: 00:59 CET (Europe/Vienna)

Nothing shows a lack of mathematical education more
than an overly precise calculation.    Carl Friedrich Gauß

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