Endogenous NTI drugs [Regulatives / Guidelines]

posted by NK – India, 2018-09-19 07:31 (731 d 02:45 ago) – Posting: # 19292
Views: 1,023

Dear All,

Whether below mentioned statement will be applied to drug categorized as endogenous & NTI drugs?

"baseline-adjusted pre-dose concentrations (at time 0 hour) greater than 5% of their Cmax should be excluded from the bioequivalence statistical analysis"


Complete thread:

 Admin contact
21,068 posts in 4,392 threads, 1,466 registered users;
online 6 (0 registered, 6 guests [including 3 identified bots]).
Forum time: Saturday 10:17 CEST (Europe/Vienna)

The purpose of models is not to fit the data,
but to sharpen the questions.    Samuel Karlin

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