Journal article
Requirements for the clinical evaluation of new anti-tuberculosis agents in children
PR Donald, A Ahmed, WJ Burman, MF Cotton, SM Graham, C Mendel, H McIlleron, WR Mac Kenzie, S Nachman, HS Schaaf, JR Starke, C Wingfield, AC Hesseling
International Journal of Tuberculosis and Lung Disease | INT UNION AGAINST TUBERCULOSIS LUNG DISEASE (I U A T L D) | Published : 2013
Abstract
The ultimate goal of evidence-based drug treatment is to produce a desired pharmacological response in a predictable manner and also to minimise adverse effects. This goal requires not only an increased awareness of the need to provide specific dosing recommendations aimed at specific patient groups, but also the implementation of a consistent integrative approach to recognise all factors contributing to the within- and between-subject variability in drug disposition and response. The assessment of new anti-tuberculosis agents and regimens in children requires a specific programme of investigation, and should be included early in human drug evaluation programmes. Appreciation of this princip..
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Funding Acknowledgements
PRD, MDC, ACH and AA receive financial support from the TBTC, which is funded by the USPHS through the CDC. AA also receives financial support from the Tuberculosis Epidemiologic Studies Consortium, also funded through the CDC. MFC, SN and ACH also receive support from IMPAACT. WRM is a project officer with the Tuberculosis Trials Consortium, CDC, USPHS.