Bioanalysis of drop out/ Withdrawal subjects for Health Canada submission [Bioanalytics]

posted by Ohlbe – France, 2024-06-03 11:13 (16 d 01:39 ago) – Posting: # 24017
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Dear Shreyas,

❝ What can be the consequences if drop out subjects due to personal reason or protocol non-compliance are been analyzed during bioanalytical stage.

The guidance says that you do not have to analyse them, not that you should not analyse them. They're just trying to spare you some time and money. If you have already spent them, well, too bad for you, but I don't see why they would care.


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