SUPAC level 3 changes for MR formulations [Regulatives / Guidelines]

posted by Mithu – India, 2019-10-23 09:21 (342 d 12:25 ago) – Posting: # 20716
Views: 1,643

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

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