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RegisterICH M13A published [Design Issues]
Hello again,
That is one thing. Another aspect is of course that in these special cases there is good reason to take a scientific advice.
Also, from the regulators perspective there will often be some thinking along the lines of picking the conditions that maximise the chances of detecting a difference, if a difference exists.
If you can argue that "meal 30 minutes before dosing" is more sensitive to detect a difference than "dosing at the start of the meal" then there's your answer. In practice, this often strands on a lack of evidence, though. I do not know of any generic company much interested in studying the phenomenon to get an answer to it.
But where did the t=20 minute first sample enter the story? Is there a product-specific guideline?
❝ You can withdraw blood while subject is having their meal. Do you see any challenge here?
That is one thing. Another aspect is of course that in these special cases there is good reason to take a scientific advice.
Also, from the regulators perspective there will often be some thinking along the lines of picking the conditions that maximise the chances of detecting a difference, if a difference exists.
If you can argue that "meal 30 minutes before dosing" is more sensitive to detect a difference than "dosing at the start of the meal" then there's your answer. In practice, this often strands on a lack of evidence, though. I do not know of any generic company much interested in studying the phenomenon to get an answer to it.
But where did the t=20 minute first sample enter the story? Is there a product-specific guideline?
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Pass or fail!
ElMaestro
Pass or fail!
ElMaestro
Complete thread:
- Fed conditions → timing of meal zuzanna 2024-07-31 07:54
![[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 publishedElMaestro 2024-08-02 15:14
- ICH M13A published zuzanna 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