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

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Implementation of a Bayesian design in a dose-escalation study of an experimental agent in healthy volunteers. / Whitehead, John; Korhonen, Pasi; Mustonen, Mika et al.
In: Biometrics, Vol. 64, No. 1, 03.2008, p. 299-308.

Research output: Contribution to Journal/Magazine › Journal article › peer-review

Harvard

Whitehead, J, Korhonen, P, Mustonen, M & Zhou, Y 2008, 'Implementation of a Bayesian design in a dose-escalation study of an experimental agent in healthy volunteers.', Biometrics, vol. 64, no. 1, pp. 299-308. https://doi.org/10.1111/j.1541-0420.2007.00841.x

APA

Whitehead, J., Korhonen, P., Mustonen, M., & Zhou, Y. (2008). Implementation of a Bayesian design in a dose-escalation study of an experimental agent in healthy volunteers. Biometrics, 64(1), 299-308. https://doi.org/10.1111/j.1541-0420.2007.00841.x

Vancouver

Whitehead J, Korhonen P, Mustonen M, Zhou Y. Implementation of a Bayesian design in a dose-escalation study of an experimental agent in healthy volunteers. Biometrics. 2008 Mar;64(1):299-308. doi: 10.1111/j.1541-0420.2007.00841.x

Author

Whitehead, John ; Korhonen, Pasi ; Mustonen, Mika et al. / Implementation of a Bayesian design in a dose-escalation study of an experimental agent in healthy volunteers. In: Biometrics. 2008 ; Vol. 64, No. 1. pp. 299-308.

Bibtex

@article{6ffa790ad4234b5c8788e74be444dd3d,
title = "Implementation of a Bayesian design in a dose-escalation study of an experimental agent in healthy volunteers.",
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.",
author = "John Whitehead and Pasi Korhonen and Mika Mustonen and Yinghui Zhou",
note = "RAE_import_type : Journal article RAE_uoa_type : Statistics and Operational Research",
year = "2008",
month = mar,
doi = "10.1111/j.1541-0420.2007.00841.x",
language = "English",
volume = "64",
pages = "299--308",
journal = "Biometrics",
issn = "1541-0420",
publisher = "Wiley-Blackwell",
number = "1",

}

RIS

TY - JOUR

T1 - Implementation of a Bayesian design in a dose-escalation study of an experimental agent in healthy volunteers.

AU - Whitehead, John

AU - Korhonen, Pasi

AU - Mustonen, Mika

AU - Zhou, Yinghui

N1 - RAE_import_type : Journal article RAE_uoa_type : Statistics and Operational Research

PY - 2008/3

Y1 - 2008/3

N2 - 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.

AB - 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.

U2 - 10.1111/j.1541-0420.2007.00841.x

DO - 10.1111/j.1541-0420.2007.00841.x

M3 - Journal article

VL - 64

SP - 299

EP - 308

JO - Biometrics

JF - Biometrics

SN - 1541-0420

IS - 1

ER -