The other way around? [Design Issues]

posted by ElMaestro  – Denmark, 2012-10-27 16:31 (4991 d 01:13 ago) – Posting: # 9469
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Dear drgunasakaran1,

❝ If the qualitative test for Lorazepam or quantitative test for Lorazepam shows positive, then you need to exclude the subject from the study.


Or perhaps it should be the other way around. If the subject tests BZ-positive and the identity is not Lorazepam, then the subject is a protocol violater and should be terminated. If the identity of the BZ is Lorazepam, then it could be carry-over as described above, and the subject would in this case not not be a protocol violator (unless it can be proven (s)he took Lorazepam between the periods) and dosing in period II would take place for this subject.

Pass or fail!
ElMaestro

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