balakotu
★    

India,
2018-05-21 13:31

Posting: # 18792
Views: 1,492
 

 Replicate Study design for Brazil [Regulatives / Guidelines]

Dear All,

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).

Regards
Kotu


Edit: No need to post identical text twice within three days. The other post deleted (see the Forum’s Policy). [Helmut]
Helmut
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Vienna, Austria,
2018-05-21 16:47

@ balakotu
Posting: # 18794
Views: 1,219
 

 ABEL acc. to WHO

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.

Cheers,
Helmut Schütz
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weidson
☆    

Brazil,
2018-05-22 20:51

@ balakotu
Posting: # 18799
Views: 1,169
 

 Replicate Study design for Brazil

Dear balakotu

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.


Best Regards
Weidson C. de Souza


Edit: Post moved. [Helmut]
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