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Register§10(1) TO 10(3) shift due to altered BE results [Regulatives / Guidelines]
Hi Tina,
According to EMA's guideline, for IR formulation if the reference, according to its SPC, can be taken irrespective of meal (I assume this is the case based on your description) then only 1 fasting study would be enough. I'm interested to know why you did fed study as well?
As for your question ElMaestro has already answered.
❝ I am currently working on an IR generic product.The reference comparator SPC mentions no information of PK differences and meals. SD fed and fasted study was conducted for EU submission.
According to EMA's guideline, for IR formulation if the reference, according to its SPC, can be taken irrespective of meal (I assume this is the case based on your description) then only 1 fasting study would be enough. I'm interested to know why you did fed study as well?
As for your question ElMaestro has already answered.
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All the best,
Shuanghe
All the best,
Shuanghe
Complete thread:
- §10(1) TO 10(3) shift due to altered BE results Tina 2013-05-24 18:02
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- §10(1) TO 10(3) shift due to altered BE results ElMaestro 2013-05-24 18:15
- §10(1) TO 10(3) shift due to altered BE resultsShuanghe 2013-05-27 15:47
Ing. Helmut Schütz