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Regulatory and methodologic challenges to tocolytic development
1University of Southern California, Women's and Children's Hospital, Los Angeles, CA, USA. tgoodwin@usc.edu
Abstract:
The development of tocolytic medications faces challenges common to all drug development programmes, principally related to evolving understanding of the pathophysiology. There are unique impediments to drug development for pregnancy-related conditions in general and for tocolysis in particular. The purpose of this brief overview is to familiarize the obstetrician with the current challenges to drug development, focusing in particular on the problems of tocolytic development. A strategy for encouraging drug development for preterm labour and for pregnancy-related problems in general is presented.
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