ICH M13 Guidance and Health Canada [Regulatives / Guidelines]

posted by AB661 – India, 2024-10-01 07:09 (277 d 19:47 ago) – Posting: # 24207
Views: 2,448

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

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