SUPAC level 3 changes for MR formulations [Regulatives / Guidelines]
Hi,
Yes.
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]
- 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