ANVISA – likely no scaling [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2012-11-14 16:02 (4151 d 22:14 ago) – Posting: # 9533
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Dear Kotu!

❝ Whether for Brazil the BE criterion is similar to Europe approach or USA approach?


AFAIK neither; i.e., no scaling.

❝ What is the BE criterion for Replicate study designs (2 treatments, 4 periods replicate) for Brazil submission.

❝ As per Brazil guideline “Evidence Guide for relative bioavailability/bioequivalence medicines” it is given in statistical analysis section 3.2 (f) that “Other limits of 90% CI for Cmax, previously established in the protocol, may be accepted by scientific justifications”.

❝ The above criterion given is for two-way cross over study.


No, section 3.2 deals with all types of designs.

❝ The same is applicable for replicate studies are not.


See above. Resolution 898 (29 May 2003) suggests replicated designs for CVintra ≥30%. Resolutions 896 (29 May 2003) and 1170 (19 April 2006) you quoted above allow other (=wider) acceptance limits – but already fixed in the protocol. This is not reference-scaling (like for the FDA and EMA), where these limits are based on CVWR estimated in the study. I guess this method is similar to the one mentioned in the obsolte European Q&A-document from 2006 where 75–133% for Cmax were acceptable if CVWR >30% was shown in a replicate design.

But: ANVISA’s website is a black hole (sink of information) and the above may be outdated. If you want to be sure send an e-mail to [image] bioequivalencia[image]anvisa.gov.br.

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