• Open Access

The status of pharmacometrics in pregnancy: highlights from the 3rd American conference on pharmacometrics

Authors


Mr J. G. Coen van Hasselt, Department of Clinical Pharmacology, Netherlands Cancer Institute, Louwesweg 6, PO Box 90440, 1006 BK Amsterdam, the Netherlands. Tel.: +31 20 512 4665, Fax: +31 20 512 2050, E-mail: jgc.vanhasselt@gmail.com

Abstract

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.

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