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

posted by jag009  – NJ, 2019-10-24 07:34 (1505 d 01:56 ago) – Posting: # 20717
Views: 2,314

Hi,

❝ ❝ Did you read the SUPAC guidance for IR?

❝ Yes.


Then you should know which level of SUPAC change requires a biostudy. It's in there.

❝ ❝ 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.


Fasting study is the one which SUPAC requires for a site change application.

J

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