Should pregnancy be considered as SAE? [Study Performance]
Dear El Maestro,
I fully agree, but...
... then I would expect the trial to be done only in male volunteers.
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
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
- Should pregnancy be considered as SAE? ratnakar1811 2014-06-20 11:14
- Should pregnancy be considered as SAE? ElMaestro 2014-06-20 00:49
- Should pregnancy be considered as SAE?Ohlbe 2014-06-19 22:40