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AB661 ☆ India, 2024-10-01 07:09 (221 d 17:18 ago) Posting: # 24207 Views: 1,695 |
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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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Helmut ★★★   Vienna, Austria, 2024-10-01 08:29 (221 d 15:58 ago) @ AB661 Posting: # 24208 Views: 1,367 |
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Hi AB661 ❝ After implementation of ICH M13 (A, B, C) Guidance, whether Health Canada will revise acceptance criteria for Cmax? See this post and the following. If (if!) HC will implement the guidelines, yes. — Dif-tor heh smusma 🖖🏼 Довге життя Україна! ![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png) Helmut Schütz ![[image]](https://static.bebac.at/img/CC by.png) The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
Ing. Helmut Schütz