ICH M13A published [Design Issues]

posted by zuzanna – Poland, 2024-08-03 23:16 (292 d 18:03 ago) – Posting: # 24127
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Hi QA,

❝ You can withdraw blood while subject is having their meal. Do you see any challenge here?


Yes, the challenge is indeed there. The median Tmax is expected to be 1.5h, and the range may start at 40 min or even earlier. I'm afraid to have DLs about the unreliable PK profile with some Tmax at the first sampling points.

Hi ElMaestro,
Yes, the SA will be the best option here, but, unfortunately, we need to start the study ASAP :-(
I have found one info from Q&A EMA BE guideline that for MR products meal 30min before drug administration is considered "the worse case scenario" compared to SmPC timing. But first, this is for MR products, and second, it was in 2010 ;-)


Edit: Standard quotes restored; see also this post #8. Please don’t use small fonts for long text. [Helmut]

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