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Back to the forum  Query: 2018-05-20 12:10 CEST (UTC+2h)
 

ANVISA: strange [Regulatives / Guidelines]

posted by balakotu - India, 2018-05-18 14:14  - Posting: # 18781
Views: 34

Dear Mr.Helmut / 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

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