Bioequivalence and Bioavailability Forum

Should pregnancy be considered as SAE? [Study Performance]

posted by ElMaestro – Denmark, 2014-06-20 02:49 (4036 d 02:02 ago) – Posting: # 13096
Views: 6,350

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:

Should pregnancy be considered as SAE? ratnakar1811 2014-06-19 08:37
- Should pregnancy be considered as SAE? Ohlbe 2014-06-19 11:21
- Should pregnancy be considered as SAE? ElMaestro 2014-06-19 19:33
  - Should pregnancy be considered as SAE? Ohlbe 2014-06-19 22:40
    - Should pregnancy be considered as SAE?ElMaestro 2014-06-20 00:49
      - Should pregnancy be considered as SAE? ratnakar1811 2014-06-20 11:14
        
        Should pregnancy be considered as SAE? mittyri 2014-07-22 19:33

Should pregnancy be considered as SAE? [Study Per­for­mance]

Complete thread:

Should pregnancy be considered as SAE? [Study Performance]