Sentinel dosing: A proposed algorithm to guide decision making on which cohorts in early phase clinical pharmacology trials should use this approach
The algorithm provides further guidance and specification on when to implement sentinel dosing in early phase clinical trials, thereby creating a standardised and harmonised approach, which will improve the protection of subject safety and trial efficiency.
Authors
- Geert Jan Groeneveld (ORCID: https://orcid.org/0000-0002-4655-6667)
- Ewoud‐Jan van Hoogdalem (ORCID: https://orcid.org/0000-0002-4334-2073)
- Wim J. Tamminga
- Perry de Jongh
- Pieter de Graeff
- Jules A. A. C. Heuberger (ORCID: https://orcid.org/0000-0001-7202-5088)
Institutions
- Leiden University Medical Center (NL)
- Dialyse Centrum Groningen (NL)
- Centre for Human Drug Research (NL)
Publication Details
- Journal
- British Journal of Clinical Pharmacology
- Published
- 2025-05-15
- DOI
- https://doi.org/10.1002/bcp.70090
- Citations
- 2
- Primary Topic
- Statistical Methods in Clinical Trials
- Type
- article
- Field-Weighted Citation Impact
- 5.26