Bioequivalence and Bioavailability Forum • Should pregnancy be considered as SAE?

Should pregnancy be considered as SAE? [Study Performance]

posted by Ohlbe – France, 2014-06-20 00:40 (4035 d 17:16 ago) – Posting: # 13095
Views: 6,320

Dear El Maestro,

I fully agree, but...

❝ If the IMP is teratogenic or if the label carries a warning against use during pregnancy

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

—
Regards
Ohlbe

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

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