ABEL acc. to WHO [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2018-05-21 18:47 (2137 d 21:54 ago) – Posting: # 18794
Views: 2,253

Hi Kotu,

❝ […] Acceptance off Bio equivalence studies conducted in Replicate study design by ANVISA (Brazil).


Replicate designs – although for average bioequivalence – are acceptable for the ANVISA for ages (even mentioned in the guidance).

❝ […] what is the acceptance criteria to be followed (USFDA/Europe Approach).


If you mean reference-scaling, the latter (actually the WHO’s). See this post. Confirmed by a Brazilian colleague earlier this month.

Dif-tor heh smusma 🖖🏼 Довге життя Україна! [image]
Helmut Schütz
[image]

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

Complete thread:

UA Flag
Activity
 Admin contact
22,957 posts in 4,819 threads, 1,638 registered users;
74 visitors (0 registered, 74 guests [including 6 identified bots]).
Forum time: 15:41 CET (Europe/Vienna)

Nothing shows a lack of mathematical education more
than an overly precise calculation.    Carl Friedrich Gauß

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