Posting: # 18792
Brazil submission: Thus any body have any idea on Acceptance off Bio equivalence studies conducted in Replicate study design by ANVISA (Brazil). If acceptable what is the acceptance criteria to be followed (USFDA/Europe Approach).
Edit: No need to post identical text twice within three days. The other post deleted (see the Forum’s Policy). [Helmut]
Posting: # 18794
» […] 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.
The quality of responses received is directly proportional to the quality of the question asked. ☼
Posting: # 18799
The ANVISA have adopted the EMA's Approach. However, for you use this approach you need to convince them that their drug is highly variable. I hope I have helped you.
Weidson C. de Souza
Edit: Post moved. [Helmut]