ICH M13 Guidance and Health Canada [Regulatives / Guidelines]

posted by AB661 – India, 2024-10-01 07:09 (282 d 07:42 ago) – Posting: # 24207
Views: 2,469

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

Complete thread:

UA Flag
Activity
 Admin contact
23,428 posts in 4,929 threads, 1,682 registered users;
54 visitors (0 registered, 54 guests [including 9 identified bots]).
Forum time: 14:52 CEST (Europe/Vienna)

To know that we know what we know,
and to know that we do not know what we do not know,
that is true knowledge.    Nicolaus Copernicus

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5