NK
☆    

India,
2018-09-19 09:31
(2097 d 21:25 ago)

Posting: # 19292
Views: 1,503
 

 Endogenous NTI drugs [Regulatives / Guidelines]

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"

Regards
NK
UA Flag
Activity
 Admin contact
23,057 posts in 4,840 threads, 1,641 registered users;
128 visitors (0 registered, 128 guests [including 82 identified bots]).
Forum time: 06:57 CEST (Europe/Vienna)

If you tell the truth you don’t have to remember anything.    Mark Twain

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