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The status of pharmacometrics in pregnancy: highlights from the 3rd American conference on pharmacometrics
Article first published online: 13 NOV 2012
© 2012 The Authors. British Journal of Clinical Pharmacology © 2012 The British Pharmacological Society
British Journal of Clinical Pharmacology
Volume 74, Issue 6, pages 932–939, December 2012
How to Cite
van Hasselt, J. G. C., Andrew, M. A., Hebert, M. F., Tarning, J., Vicini, P. and Mattison, D. R. (2012), The status of pharmacometrics in pregnancy: highlights from the 3rd American conference on pharmacometrics. British Journal of Clinical Pharmacology, 74: 932–939. doi: 10.1111/j.1365-2125.2012.04280.x
- Issue published online: 13 NOV 2012
- Article first published online: 13 NOV 2012
- Accepted manuscript online: 27 MAR 2012 05:41AM EST
- Received; 23 January 2012; Accepted; 20 March 2012; Accepted Article Published Online; 27 March 2012
- maternal-fetal medicine;
- modelling and simulation;
Physiological changes during pregnancy may alter drug pharmacokinetics. Therefore, mechanistic understanding of these changes and, ultimately, clinical studies in pregnant women are necessary to determine if and how dosing regimens should be adjusted. Because of the typically limited number of patients who can be recruited in this patient group, efficient design and analysis of these studies is of special relevance. This paper is a summary of a conference session organized at the American Conference of Pharmacometrics in April 2011, around the topic of applying pharmacometric methodology to this important problem. The discussion included both design and analysis of clinical studies during pregnancy and in silico predictions. An overview of different pharmacometric methods relevant to this subject was given. The impact of pharmacometrics was illustrated using a range of case examples of studies around pregnancy.