Sentinel dosing: A proposed algorithm to guide decision making on which cohorts in early phase clinical pharmacology trials should use this approach

Aim The aim of this paper is to describe a proposal for an algorithm to guide decision making on which cohorts in early phase pharmacology trials should employ a sentinel approach, thereby standardising and harmonising practices, and improving decision making around sentinel dosing. Sentinel dosing...

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Bibliographic Details
Published in:	British journal of clinical pharmacology Vol. 91; no. 9; pp. 2705 - 2710
Main Authors:	Heuberger, Jules A. A. C., Jongh, Perry, Hoogdalem, Ewoud‐Jan, Tamminga, Wim, Graeff, Pieter, Groeneveld, Geert Jan
Format:	Journal Article
Language:	English
Published:	England John Wiley and Sons Inc 01.09.2025
Subjects:	Algorithms Clinical Trials, Phase I as Topic - methods Clinical Trials, Phase I as Topic - standards Decision Making Decision Trees Dose-Response Relationship, Drug drug development first‐in‐human Humans Netherlands Original regulation Research Design sentinel dosing study design Netherlands drug development sentinel dosing regulation study design first‐in‐human
ISSN:	0306-5251, 1365-2125, 1365-2125
Online Access:	Get full text
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