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| Name | Class |
|---|---|
| Janssen Pharmaceuticals | INDUSTRY |
| Merck Sharp & Dohme LLC | INDUSTRY |
| PENTA Foundation | NETWORK |
| Top sector Life Sciences & Health |
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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).
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| Measure | Description | Time Frame |
|---|---|---|
| placental transfer | 1.) An ex-vivo placenta perfusion model will be used to estimate placental passage of drugs | at delivery |
| histological profiling | Histological and protein profiling experiments will be conducted to investigate factors that may influence the placental passage and disposition of drugs (e.g. the abundance, localization and inter-individual variation of expression of enzymes and transporters). | at delivery |
| in vitro experiments | Furthermore, in vitro experiments will be conducted to estimate the pharmacodynamic effects of drugs on the placental barrier function itself (e.g. whether exposure to drugs can induce/reduce the expression of enzymes and transporters, as has been reported for several organs, such as the liver, intestine and kidney). | at delivery |
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Inclusion Criteria:
Exclusion Criteria:
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Pregnant women
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| J van Drongelen | Contact | joris.vandrongelen@Radboudumc.nl |
| Name | Affiliation | Role |
|---|---|---|
| J van Drongelen | Radboud University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radboud University Medical Centre | Recruiting | Nijmegen | Gelderland | Netherlands |
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Placental tissue is retained, limited sample. DNA will not be analysed.