Abstract
Drug development for obstetrics occurs via an informal process of migration from use in adults, irrespective of the therapeutic target; mother, placenta or fetus. This informal process means that use during pregnancy is off-label, with dosing, pharmacokinetics, pharmacodynamics, safety and efficacy not described in regulatory documents or product labels. This is a special concern owing to the complex physiological, cellular and molecular changes that occur across pregnancy. In addition, special attention must be given to the placenta owing to its role in transport between mother and fetus, and metabolism, as well as vulnerability to toxicity. This article will consider how maternal physiology changes and impacts drug disposition with emphasis on the role of the placenta in drug development.
Financial & competing interests disclosure
Funding for this work has been provided in part by the Eunice Kennedy Shriver National Institute of Child Health and Human Development, NIH to DRM and the University Hospital Zurich to AM. This article was prepared in part by DRM as an employee of the US Government making this a ‘work of the US Government’ and therefore copyright is nontransferable. The opinions stated in this article are those of the authors and do not necessarily represent the views of the Department of Health and Human Services, the NIH or the Eunice Kennedy Shriver National Institute of Child Health and Human Development. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.
No writing assistance was utilized in the production of this manuscript.