No correction if ≤5% Cmax [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2012-04-05 18:08 (3580 d 11:43 ago) – Posting: # 8390
Views: 8,349

Hi John!

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

Can? Technically, yes. But I wouldn’t recommend it (see the [image] 2003 guidance):(my emphasis; interpreting “can” as “should”…)

Dif-tor heh smusma 🖖
Helmut Schütz
[image]

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

Complete thread:

Activity
 Admin contact
21,844 posts in 4,571 threads, 1,555 registered users;
online 3 (0 registered, 3 guests [including 3 identified bots]).
Forum time: Monday 04:52 CET (Europe/Vienna)

Do, or do not.
There is no ‘try’.    Yoda

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