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RegisterSequences of BE study under both fasting and fed studies [Design Issues]
Hi A. Shtaiwi,
In my experience option 2 has been rather commonly used and accepted.
The others may be as well but I don't have a lot of experience.
In my experience, yes. But I think companies tend to start with the "without charcoal" matter first.
There could be national preferences. I mean, if you approach DE and SE for sc. advice then they might not have exactly the same opinion or preference.
❝ Which approach would regulators (e.g. EMA) accept?
In my experience option 2 has been rather commonly used and accepted.
The others may be as well but I don't have a lot of experience.
❝ Also, would the same logic apply to studies of orally inhaled products where we compare “with charcoal” vs “without charcoal” (instead of fasting vs fed)?
In my experience, yes. But I think companies tend to start with the "without charcoal" matter first.
There could be national preferences. I mean, if you approach DE and SE for sc. advice then they might not have exactly the same opinion or preference.
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Pass or fail!
ElMaestro
Pass or fail!
ElMaestro
Complete thread:
- Sequences of BE study under both fasting and fed studies A.Shtaiwi 2025-09-03 12:40
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Sequences of BE study under both fasting and fed studiesElMaestro 2025-09-04 08:05
- Sequences of BE study under both fasting and fed studies A.Shtaiwi 2025-09-07 05:52
- Fed → fasting Helmut 2025-09-04 08:26
- Fed (failed) → fasting (succeeded) mittyri 2025-09-22 11:01
- Fed (failed) → fasting (succeeded) Helmut 2025-09-23 15:35
- Fed (failed) → fasting (succeeded) mittyri 2025-09-22 11:01
- Sequences of BE study under both fasting and fed studiesElMaestro 2025-09-04 08:05
Ing. Helmut Schütz