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RegisterICH M13A published [Design Issues]
Hi QA,
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]
❝ 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
- Q:
For Modified Release products, is it still recommended to dose the tablet 30 minutes after a high fat high calorie meal, even if this is not in line with the timing of administration according to the SmPC?
- A:
For Modified Release products, the dosing of tablet should take place after 30 minutes so as to mimic a ‘worst case situation’, regardless of potential other SmPC recommendations.
Edit: Standard quotes restored; see also this post #8. Please don’t use small fonts for long text. [Helmut]
Complete thread:
- Fed conditions → timing of meal zuzanna 2024-07-31 07:54 [Design Issues]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- ICH M13A Helmut 2024-07-31 09:14
- ICH M13A zuzanna 2024-07-31 10:32
- ICH M13A published Helmut 2024-07-31 12:21
- ICH M13A published zuzanna 2024-07-31 13:47
- ICH M13A published ElMaestro 2024-07-31 14:14
- ICH M13A published zuzanna 2024-08-01 12:49
- ICH M13A published qualityassurance 2024-08-02 05:09
- ICH M13A published ElMaestro 2024-08-02 15:14
- ICH M13A publishedzuzanna 2024-08-03 21:16
- ICH M13A published qualityassurance 2024-08-05 12:45
- ICH M13A published qualityassurance 2024-08-02 05:09
- ICH M13A published zuzanna 2024-08-01 12:49
- ICH M13A published ElMaestro 2024-07-31 14:14
- ICH M13A published zuzanna 2024-07-31 13:47
- ICH M13A published Helmut 2024-07-31 12:21
- ICH M13A zuzanna 2024-07-31 10:32
- ICH M13A Helmut 2024-07-31 09:14
Ing. Helmut Schütz