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ISR for pilot study [Bioanalytics]

posted by jag009 – NJ, 2014-04-11 19:50 (4064 d 03:28 ago) – Posting: # 12817
Views: 5,108

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

Complete thread:

ISR for pilot study Ken Peh 2014-04-11 16:37
- ISR for pilot studyjag009 2014-04-11 17:50
- ISR for pilot study Ohlbe 2014-04-11 17:59
  - ISR for pilot study jag009 2014-04-11 21:44
    - ISR for pilot study Ken Peh 2014-04-12 08:32

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