Replicate Study design for Brazil [Regulatives / Guidelines]

posted by balakotu – India, 2018-05-21 13:31 (1119 d 03:31 ago) – Posting: # 18792
Views: 2,257

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]

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