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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.

Original publication

DOI

10.1111/j.1365-2125.2012.04280.x

Type

Journal article

Journal

Br J Clin Pharmacol

Publication Date

12/2012

Volume

74

Pages

932 - 939

Keywords

Biomedical Research, Clinical Trials as Topic, Computer Simulation, Drug-Related Side Effects and Adverse Reactions, Female, Humans, Maternal-Fetal Exchange, Models, Biological, Pharmacokinetics, Pharmacology, Pregnancy, Research Design