bioequivalence criteria for NTID [Regulatives / Guidelines]

posted by Biostats – India, 2018-03-30 06:25 (1303 d 21:55 ago) – Posting: # 18623
Views: 4,207

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
 Admin contact
21,753 posts in 4,548 threads, 1,544 registered users;
online 3 (0 registered, 3 guests [including 3 identified bots]).
Forum time: Sunday 04:21 CEST (Europe/Vienna)

They were “so intent of making everything numerical”
that they frequently missed seeing
what was there to be seen.    Barbara McClintock

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