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

posted by nobody – 2020-02-12 09:49 (2318 d 15:05 ago) – Posting: # 21163
Views: 13,316

❝ ❝ 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;
99 visitors (0 registered, 99 guests [including 10 identified bots]).
Forum time: 01:55 CEST (Europe/Vienna)

“Data! Data! Data!” he cried impatiently.
“I can’t make bricks without clay!”    Arthur Conan Doyle

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