Should pregnancy be considered as SAE? [Study Per­for­mance]

posted by Ohlbe – France, 2014-06-20 00:40 (3569 d 10:11 ago) – Posting: # 13095
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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

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