Should pregnancy be considered as SAE? [Study Per­for­mance]

posted by ElMaestro  – Denmark, 2014-06-20 02:49 (3595 d 10:50 ago) – Posting: # 13096
Views: 5,260

Dear Ohlbe,

❝ ... then I would expect the trial to be done only in male volunteers.


That makes good sense.
Quick example illustrating my post above: here.

The ref. UK SPC reads (section 4.6): "(...) moxifloxacin must not be used in pregnant women (...)"

Pass or fail!
ElMaestro

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