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RegisterReplicate study design for Brazil submission [Regulatives / Guidelines]
Dear all,
Please suggest the criteria for opting Replicate study design for Brazil submission.
What is the BE criterion for Replicate study designs (2 treatments, 4 periods replicate) for Brazil submission.
Whether for Brazil the BE criterion is similar to Europe approach or USA approach?
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.
The same is applicable for replicate studies are not. Please specify.
Regards
Kotu.
Please suggest the criteria for opting Replicate study design for Brazil submission.
What is the BE criterion for Replicate study designs (2 treatments, 4 periods replicate) for Brazil submission.
Whether for Brazil the BE criterion is similar to Europe approach or USA approach?
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.
The same is applicable for replicate studies are not. Please specify.
Regards
Kotu.
Complete thread:
- Replicate study design for Brazil submissionbalakotu 2012-11-14 09:49
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- ANVISA – likely no scaling Helmut 2012-11-14 15:02
- ANVISA – likely no scaling luvblooms 2012-11-16 05:27
- ANVISA: strange Helmut 2012-11-16 14:14
- ANVISA – likely no scaling luvblooms 2012-11-16 05:27
- ANVISA – likely no scaling Helmut 2012-11-14 15:02
Ing. Helmut Schütz