ABEL acc. to WHO [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2018-05-21 16:47 (1338 d 09:34 ago) – Posting: # 18794
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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.

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Helmut Schütz

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