bioequivalence criteria for NTID [Regulatives / Guidelines]

posted by Biostats – India, 2018-03-30 04:25  – Posting: # 18623
Views: 2,420

Thanks Sir,

Is it mandatory to check - point estimate of the Test/Reference geometric mean ratio must fall within 80.00 - 125.00%?


Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5[Helmut]

Complete thread:

Activity
 Mix view
Bioequivalence and Bioavailability Forum |  Admin contact
19,405 posts in 4,122 threads, 1,323 registered users;
online 6 (0 registered, 6 guests [including 6 identified bots]).
Forum time (Europe/Vienna): 04:28 UTC

[Those] who have an excessive faith in their theories or in their
ideas are not only poorly disposed to make discoveries, but they
also make very poor observations.    Claude Bernard

The BIOEQUIVALENCE / BIOAVAILABILITY FORUM is hosted by
BEBAC Ing. Helmut Schütz
HTML5