Do your homework first [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2022-09-01 18:40 (659 d 21:06 ago) – Posting: # 23257
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Hi Mithu,

❝ My question is, in steady state studies, does 90% CI is mandatory to apply for Ctau? I believe it is secondary parameter and requires to submit as supportive Pharmacokinetic.


Do you see the tab Guidelines on top of the page?

For the EMA see the current guideline Section 6.8.2. AFAIK, not required for the FDA.

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