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RegisterHVDP for Health Canada [Regulatives / Guidelines]
Dear All,
Please clarify,
As per recent approach for highly variable drug products, health Canada accepts studies in full replicate or partial replicate design with widening of confidence intervals for AUC.
For such studies that will be conducted in full replicate or partial replicate studies for health Canada submissions, how to evaluate the subjects completing only two treatment periods; one with test product and other with reference product i.e (TR or RT).
Whether these subjects should be included or excluded for Bioequivalence assessment.
Regards
Kotu
Please clarify,
As per recent approach for highly variable drug products, health Canada accepts studies in full replicate or partial replicate design with widening of confidence intervals for AUC.
For such studies that will be conducted in full replicate or partial replicate studies for health Canada submissions, how to evaluate the subjects completing only two treatment periods; one with test product and other with reference product i.e (TR or RT).
Whether these subjects should be included or excluded for Bioequivalence assessment.
Regards
Kotu
Complete thread:
- HVDP for Health Canadabalakotu 2017-03-21 12:16 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- HVDP for Health Canada Dr_Dan 2017-03-21 13:10
Ing. Helmut Schütz