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Placental Passage and Disposition of Drugs: A Physiology-based Approach — PIANO  

Pregnancy Clinical Trial

Official title:
Placental Passage and Disposition of Drugs: A Physiology-based Approach

Clinical Trial 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).

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02438631
Study type Observational
Source Radboud University Medical Center
Contact J van Drongelen
Email joris.vandrongelen@Radboudumc.nl
Status Recruiting
Phase
Start date February 2015
Completion date December 2028
View Details
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