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RegisterSUPAC level 3 changes for MR formulations [Regulatives / Guidelines]
Hi,
» Did you read the SUPAC guidance for IR?
Yes.
» I dont follow. Are you asking if the study should be a fasted study?
Yes. If you see guidance for Food effect, under SUPAC title (for site change), states fasting study is needed and fed generally not needed.
Regards,
Mithu
» Did you read the SUPAC guidance for IR?
Yes.
» I dont follow. Are you asking if the study should be a fasted study?
Yes. If you see guidance for Food effect, under SUPAC title (for site change), states fasting study is needed and fed generally not needed.
Regards,
Mithu
Complete thread:
- SUPAC level 3 changes for MR formulations Mithu 2019-09-30 07:42 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- SUPAC level 3 changes for MR formulations jag009 2019-10-22 21:31
- SUPAC level 3 changes for MR formulationsMithu 2019-10-23 09:21
- SUPAC level 3 changes for MR formulations jag009 2019-10-24 05:34
- SUPAC level 3 changes for MR formulationsMithu 2019-10-23 09:21
- SUPAC level 3 changes for MR formulations jag009 2019-10-22 21:31
Ing. Helmut Schütz