Home » EMEA Outlines Requirements for Drug Studies in Newborns
EMEA Outlines Requirements for Drug Studies in Newborns
December 19, 2007
Because most organ functions in newborns are still maturing, clinical trials involving this patient population should attempt to identify major developmental changes that could affect drug exposure, safety and efficacy, the European Medicines Agency (EMEA) says in a draft guideline issued in November.
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