ChloroquineV1, Main, Exploration, bibRecord, 002147

A Review and Assessment of Potential Sources of Ethnic Differences in Drug Responsiveness

Identifieur interne : 002147 ( Main/Exploration ); précédent : 002146; suivant : 002148

A Review and Assessment of Potential Sources of Ethnic Differences in Drug Responsiveness

Auteurs : Thorir D. Bjornsson [États-Unis] ; John A. Wagner [États-Unis] ; Stephen R. Donahue [États-Unis] ; Dawn Harper [États-Unis] ; Aziz Karim [États-Unis] ; Marlene S. Khouri [États-Unis] ; William R. Murphy [États-Unis] ; Kristin Roman [États-Unis] ; Dennis Schneck [États-Unis] ; Daryl S. Sonnichsen [États-Unis] ; Dennis J. Stalker [États-Unis] ; Stephen D. Wise [Singapour] ; Stuart Dombey ; Caroline Loew

Source :

The Journal of Clinical Pharmacology [ 0091-2700 ] ; 2003-09.

RBID : ISTEX:E06B493A6F8AFE8EA4929DAC52A8303D0561CE2E

Abstract

The International Conference on Harmonization (ICH) E5 guidelines were developed to provide a general framework for evaluating the potential impact of ethnic factors on the acceptability of foreign clinical data, with the underlying objective to facilitate global drug development and registration. It is well recognized that all drugs exhibit significant intersubject variability in pharmacokinetics and pharmacologic response and that such differences vary considerably among individual drugs and depend on a variety of factors. One such potential factor involves ethnicity. The objective of the present work was to perform an extensive review of the world literature on ethnic differences in drug disposition and responsiveness to determine their general significance in relation to drug development and registration. A few examples of suspected ethnic differences in pharmacokinetics or pharmacodynamics were identified. The available literature, however, was found to be heterologous, including a variety of study designs and research methodologies, and most of the publications were on drugs that were approved a long time ago.

Url:

https://api.istex.fr/ark:/67375/WNG-WXG1T0DZ-S/fulltext.pdf

DOI: 10.1177/0091270003256065

Affiliations:

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Le document en format XML

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<author><name sortKey="Wagner, John A" sort="Wagner, John A" uniqKey="Wagner J" first="John A." last="Wagner">John A. Wagner</name>
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<front><div type="abstract" xml:lang="en">The International Conference on Harmonization (ICH) E5 guidelines were developed to provide a general framework for evaluating the potential impact of ethnic factors on the acceptability of foreign clinical data, with the underlying objective to facilitate global drug development and registration. It is well recognized that all drugs exhibit significant intersubject variability in pharmacokinetics and pharmacologic response and that such differences vary considerably among individual drugs and depend on a variety of factors. One such potential factor involves ethnicity. The objective of the present work was to perform an extensive review of the world literature on ethnic differences in drug disposition and responsiveness to determine their general significance in relation to drug development and registration. A few examples of suspected ethnic differences in pharmacokinetics or pharmacodynamics were identified. The available literature, however, was found to be heterologous, including a variety of study designs and research methodologies, and most of the publications were on drugs that were approved a long time ago.</div>
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A Review and Assessment of Potential Sources of Ethnic Differences in Drug Responsiveness

A Review and Assessment of Potential Sources of Ethnic Differences in Drug Responsiveness

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Abstract

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