Lists of NTIDs [Regulatives / Guidelines]

posted by kumarnaidu – Mumbai, India, 2013-09-24 13:56 (4656 d 06:16 ago) – Posting: # 11547
Views: 7,260

Hi all,
Can anybody tell if I am doing study for canada and the drug is NTI and the acceptance limit is 80-125 for cmax and 90-112 for AUC then what upper/lower equivalence bound I have to consider for sample size calculation.

Kumar Naidu

Complete thread:

UA Flag
Activity
 Admin contact
23,655 posts in 4,993 threads, 1,570 registered users;
134 visitors (0 registered, 134 guests [including 26 identified bots]).
Forum time: 20:13 CEST (Europe/Vienna)

Scientists often have a naïve faith that
if only they could discover enough facts about a problem,
these facts would somehow arrange themselves
in a compelling and true solution.    Theodosius Dobzhansky

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