Pre dose concentration [Regulatives / Guidelines]

posted by auditor – India, 2012-02-28 08:59 (3253 d 13:23 ago) – Posting: # 8173
Views: 7,761

Dear All,

As per recent EU guideline for BA/BE, clear statement given for not to withdraw any subject in which >5% Cmax concentration observed after dosing endogenous molecule.

I am looking for such kind of clarity in US FDA guidance. Can any one please let me know is the same thing can be followed in US submission?



Complete thread:

 Admin contact
21,310 posts in 4,445 threads, 1,489 registered users;
online 4 (0 registered, 4 guests [including 4 identified bots]).
Forum time: Sunday 22:23 CET (Europe/Vienna)

Every man gets a narrower and narrower field of knowledge
in which he must be an expert in order to compete with other people.
The specialist knows more and more about less and less
and finally knows everything about nothing.    Konrad Lorenz

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