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RegisterABEL acc. to WHO [Regulatives / Guidelines]
posted by Helmut 
– Vienna, Austria, 2018-05-21 18:47 (2164 d 15:36 ago) – Posting: # 18794
Views: 2,317
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.
—
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Helmut Schütz
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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 [Regulatives / Guidelines]
![[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