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Placental Passage and Disposition of Drugs: A Physiology-based Approach
Sponsor: Radboud University Medical Center
Summary
The investigators aim to integrate the outcomes in physiology-based pharmacokinetic (PBPK) models to put the generated data into context with medical conditions that require maternal or fetal drug therapy (e.g. HIV). These models will be validated with available 'real-life' maternal and fetal PK data, such as data from the PANNA network. PBPK models of drug therapy during pregnancy will provide a powerful tool to 1.) assist in designing rational dosing adjustments, 2.) prevent intervention-based research in pregnant women in the future, and 3.) guide future development of new molecular entities (e.g. preventing heavy investment in drugs with high predicted fetal exposure and potentially toxic effects in utero).
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
2000
Start Date
2015-02
Completion Date
2028-12
Last Updated
2022-09-10
Healthy Volunteers
Yes
Conditions
Locations (1)
Radboud University Medical Centre
Nijmegen, Gelderland, Netherlands