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

posted by ElMaestro  – Belgium?, 2020-02-12 08:27  – Posting: # 21162
Views: 2,061

Hi MS,

» 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:

This week's list of things I absolutely detest: Corona virus, the which function in R, WIA-WIA interfaces for scanning under Windows 10, the Bee Gees, the smell of my fridge.

Best regards,
ElMaestro

Complete thread:

Activity
 Admin contact
20,465 posts in 4,298 threads, 1,414 registered users;
online 8 (0 registered, 8 guests [including 5 identified bots]).
Forum time (Europe/Vienna): 16:15 CEST

Confidence is the result of hours and days and weeks and years
of constant work and dedication.    Roger Staubach

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