Log in
RegisterABEL acc. to WHO [Regulatives / Guidelines]
posted by Helmut 
– Vienna, Austria, 2018-05-21 18:47 (2959 d 08:59 ago) – Posting: # 18794
Views: 3,802
Hi Kotu,
Replicate designs – although for average bioequivalence – are acceptable for the ANVISA for ages (even mentioned in the guidance).
If you mean reference-scaling, the latter (actually the WHO’s). See this post. Confirmed by a Brazilian colleague earlier this month.
❝ […] 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]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png)
Helmut Schütz
![[image]](https://static.bebac.at/img/CC by.png)
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Complete thread:
- Replicate Study design for Brazil balakotu 2018-05-21 13:31
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- ABEL acc. to WHOHelmut 2018-05-21 16:47
- Replicate Study design for Brazil Weidson 2018-05-22 20:51
Ing. Helmut Schütz