Bioanalysis discontinued subject [Regulatives / Guidelines]

posted by Johanne – Canada, 2018-08-02 00:31 (784 d 23:11 ago) – Posting: # 19125
Views: 1,905

Hello,

Since I've started to work with BE, I've always seen in protocol that bioanalysis was required to be performed for samples of subject discontinued due to AE or emesis, but could be omitted for subjects discontinued for other reasons. I'm looking for the specific guidance (EMA, FDA) related to this requirement. Can someone help ?

Joe

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