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

posted by Helmut Homepage – Vienna, Austria, 2020-02-12 13:12 (435 d 22:16 ago) – Posting: # 21164
Views: 3,907

Hi ElMaestro,

» » ignorance of the intra-individual variability of the drug;
» Ermmm...... WHAT???? :-D:party:

Lost in translation?

É aceitável usar uma abordagem de dois estágios para demonstrar a bioequivalência baseada nodesconhecimento da variabilidade do fármaco;

I have the same translation like Mauricio. Google-translate suggests ‘unknowing’ for ‘nodesconhecimento’ but if you feed the entire sentence, ‘ignorance’ shows up. :-D

Dif-tor heh smusma 🖖
Helmut Schütz

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

Complete thread:

 Admin contact
21,428 posts in 4,479 threads, 1,512 registered users;
online 15 (2 registered, 13 guests [including 5 identified bots]).
Forum time: Friday 12:29 CEST (Europe/Vienna)

There is one certainty in drug development
and statistics that one can depend on:
the data are always late.    Scott Patterson and Byron Jones

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