> 5% of Cmax for endogenous molecule? [Regulatives / Guidelines]

posted by Ramesh Ramalingam  – India, 2018-06-18 10:00 (1993 d 07:26 ago) – Posting: # 18913
Views: 3,634

Dear All,

As per guidelines, Subjects with non-zero baseline concentrations > 5% of Cmax. Such data should be excluded from bioequivalence calculation.

Is it applicable for endogenous molecule? could you please suggest anyone..



Regards,
Ramesh. R

Complete thread:

UA Flag
Activity
 Admin contact
22,811 posts in 4,783 threads, 1,632 registered users;
23 visitors (0 registered, 23 guests [including 7 identified bots]).
Forum time: 16:26 CET (Europe/Vienna)

Inspiration is constantly in the air.
It’s up to us to develop the sensitivity
to pick up on it.    Herbie Hancock

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