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RegisterICH M13 Guidance and Health Canada [Regulatives / Guidelines]
Dear All,
Query is with reference to BE study Submission to Health Canada.
As per current health Canada BE guidance, only T/R ratio requires for Cmax not 90 % CI criteria. After implementation of ICH M13 (A, B, C) Guidance, whether Health Canada will revise acceptance criteria for Cmax?
With regards
AB661
Query is with reference to BE study Submission to Health Canada.
As per current health Canada BE guidance, only T/R ratio requires for Cmax not 90 % CI criteria. After implementation of ICH M13 (A, B, C) Guidance, whether Health Canada will revise acceptance criteria for Cmax?
With regards
AB661
Complete thread:
- ICH M13 Guidance and Health CanadaAB661 2024-10-01 05:09
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- ICH M13A/C and Health Canada Helmut 2024-10-01 06:29
Ing. Helmut Schütz