ISR for pilot study [Bioanalytics]

posted by jag009  – NJ, 2014-04-11 19:50 (4065 d 05:47 ago) – Posting: # 12817
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Hi Ken,

❝ (i) Is ISR necessary for pilot study ?


FDA? No. But for us if the assay is newly developed then we would ask the lab to do ISR (yes for a pilot study) just to make sure things are okay.

John

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