Flashback [Regulatives / Guidelines]

posted by jag009  – NJ, 2012-04-05 19:51 (4375 d 02:39 ago) – Posting: # 8388
Views: 9,181

Hi Helmut,

❝ ❝ Should the lab adjust the concentration profile to remove the residual levels caused by the pre-dose concentration???? ie. using the t1/2 and determine the amount of pre-dose concentration remaining throughout the timepoints and subtract it from the respective concentrations.


❝ See above. I cannot imaging that any regulatory agency would accept this (any more).


Question, can the pre-dose (0 hr) concentration be set to 0 if it is less than 5% of Cmax? FDA that is...

Thanks

John

Complete thread:

UA Flag
Activity
 Admin contact
22,957 posts in 4,819 threads, 1,636 registered users;
76 visitors (0 registered, 76 guests [including 3 identified bots]).
Forum time: 21:30 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