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

posted by nobody – 2020-02-12 09:49 (2315 d 03:34 ago) – Posting: # 21163
Views: 13,302

❝ ❝ 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:

UA Flag
Activity
 Admin contact
23,654 posts in 4,992 threads, 1,570 registered users;
100 visitors (0 registered, 100 guests [including 15 identified bots]).
Forum time: 14:24 CEST (Europe/Vienna)

The idea is to try and give all the information to help others
to judge the value of your contribution;
not just the information that leads to judgment
in one particular direction or another.    Richard Feynman

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