External Pharmacokinetic Model Evaluation of Caffeine in Critically Ill Neonates With Heart Disease Using Data Collected From a Pragmatic Platform Trial.
External evaluation of a pediatric PopPK model using data from a pragmatic platform trial was successful. Our external evaluation supports broader adoption of pragmatic platform trials for pediatric model development and evaluation. These studies can inform starting doses for future trials, which cannot necessarily be extrapolated from other populations due to variability in drug disposition.
Authors
- Victória Etges Helfer (ORCID: https://orcid.org/0000-0002-6681-9356)
- Rachel Sielaty (ORCID: https://orcid.org/0000-0002-0044-8185)
- E. T. Thompson
- Henry Foote
- Daniel K Benjamin
- Andrea L Storer
- Jessminda DiCello
- Kanecia O Zimmerman
- Courtney Hallock
- Christoph P Hornik
- Daniel Gonzalez
- Calla Castro
- Annalisa Hawk
Institutions
- Duke University (US)
- University of Washington (US)
- Montana State University (US)
- Clinical Research Institute (US)
Publication Details
- Journal
- PubMed
- Published
- 2026-02-01
- DOI
- https://doi.org/10.5863/jppt-25-00144
- Primary Topic
- Pharmaceutical studies and practices
- Type
- article
- Field-Weighted Citation Impact
- 0.00