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Implementation of a Bayesian design in a dose-escalation study of an experimental agent in healthy volunteers.

Whitehead, John and Korhonen, Pasi and Mustonen, Mika and Zhou, Yinghui (2008) Implementation of a Bayesian design in a dose-escalation study of an experimental agent in healthy volunteers. Biometrics, 64 (1). pp. 299-308. ISSN 1541-0420

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Abstract

Summary. Bayesian decision procedures have recently been developed for dose escalation in phase I clinical trials concerning pharmacokinetic responses observed in healthy volunteers. This article describes how that general methodology was extended and evaluated for implementation in a specific phase I trial of a novel compound. At the time of writing, the study is ongoing, and it will be some time before the sponsor will wish to put the results into the public domain. This article is an account of how the study was designed in a way that should prove to be safe, accurate, and efficient whatever the true nature of the compound. The study involves the observation of two pharmacokinetic endpoints relating to the plasma concentration of the compound itself and of a metabolite as well as a safety endpoint relating to the occurrence of adverse events. Construction of the design and its evaluation via simulation are presented.

Item Type: Article
Journal or Publication Title: Biometrics
Additional Information: RAE_import_type : Journal article RAE_uoa_type : Statistics and Operational Research
Subjects: Q Science > QA Mathematics
Departments: Faculty of Science and Technology > Mathematics and Statistics
ID Code: 2461
Deposited By: ep_importer
Deposited On: 29 Mar 2008 14:50
Refereed?: Yes
Published?: Published
Last Modified: 09 Oct 2013 14:49
Identification Number:
URI: http://eprints.lancs.ac.uk/id/eprint/2461

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