Truncted AUC, low variability [Design Issues]

posted by jag009  – NJ, 2017-08-18 01:50 (2415 d 09:27 ago) – Posting: # 17707
Views: 8,278

Hi Helmut,

❝ It is an open question what a “long half-life drug” is. An numerous conferences both the FDA and the EMA refused to give a definition. Only the Canadian HPFB formerly stated t½ ≥24 hours.


So far no problems for me w FDA. I've ran 6 - 10 of these with t1/2=24 and up (okay, 3 drugs w mean 24 hrs.)

John

Complete thread:

UA Flag
Activity
 Admin contact
22,957 posts in 4,819 threads, 1,636 registered users;
110 visitors (0 registered, 110 guests [including 6 identified bots]).
Forum time: 10:18 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