Regulatory and methodologic challenges to tocolytic development
Article first published online: 19 DEC 2006
BJOG: An International Journal of Obstetrics & Gynaecology
Special Issue: Reducing the Burden of Prematurity: New Advances and Practical Challenges
Volume 113, Issue Supplement s3, pages 100–104, December 2006
How to Cite
Goodwin, T. (2006), Regulatory and methodologic challenges to tocolytic development. BJOG: An International Journal of Obstetrics & Gynaecology, 113: 100–104. doi: 10.1111/j.1471-0528.2006.01133.x
- Issue published online: 19 DEC 2006
- Article first published online: 19 DEC 2006
- Accepted 8 September 2006.
- placebo-controlled trial;
- surrogate markers;
- tocolytic drug development
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 familiarise 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.