ANVISA guidelines for two-stage design [Two-Stage / GS Designs]

posted by nobody – 2020-02-12 08:49 (390 d 23:33 ago) – Posting: # 21163
Views: 3,757

» » Art.75. For two-stage studies, the following should be noted: It is acceptable to use a two-stage approach to demonstrate bioequivalence based on ignorance of the intra-individual variability of the drug;
»
»
» Ermmm...... WHAT???? :-D:party:

Same reaction here last night, but I thought I'm hallucinating due to ovewr-day fasting.

Kindest regards, nobody

Complete thread:

Activity
 Admin contact
21,372 posts in 4,463 threads, 1,496 registered users;
online 10 (0 registered, 10 guests [including 7 identified bots]).
Forum time: Tuesday 08:22 CET (Europe/Vienna)

We learn more by looking for the answer to a question and not finding it
than we do from learning the answer itself.    Lloyd Alexander

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