Should pregnancy be considered as SAE? [Study Per­for­mance]

posted by ElMaestro  – Denmark, 2014-06-20 02:49 (4386 d 14:54 ago) – Posting: # 13096
Views: 7,728

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

Complete thread:

UA Flag
Activity
 Admin contact
23,655 posts in 4,993 threads, 1,571 registered users;
142 visitors (0 registered, 142 guests [including 15 identified bots]).
Forum time: 17:44 CEST (Europe/Vienna)

Competence, like truth, beauty and contact lenses,
is in the eye of the beholder.    Laurence J. Peter

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5