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Improving the role and contribution of pharmacokinetic analyses in antimalarial drug clinical trials.

Kay, Katherine, Hodel, Eva Maria ORCID: https://orcid.org/0000-0001-5821-1685 and Hastings, Ian ORCID: https://orcid.org/0000-0002-1332-742X (2014) 'Improving the role and contribution of pharmacokinetic analyses in antimalarial drug clinical trials.'. Antimicrobial Agents and Chemotherapy, Vol 58, Issue 10, pp. 5643-5649.

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Abstract

It is now World Health Organization (WHO) policy that drug concentrations on day 7 be measured as part of routine assessment in antimalarial drug efficacy trials. The rationale is that this single pharmacological measure serves as a simple and practical predictor of treatment outcome for long half-life antimalarial drugs. Herein we review theoretical data and field studies and conclude that the day 7 drug concentration (d7c) actually appears to be a poor predictor of therapeutic outcome. This poor predictive capability combined with the fact that many routine antimalarial trials will have few or no failures means there appears little justification for this WHO recommendation. Pharmacological studies have a huge potential to improve antimalarial dosing and we propose study designs that use more focussed, sophisticated and cost-effective ways of generating these data than the mass collection of single d7c concentrations.

Item Type: Article
Subjects: QV Pharmacology > Anti-Inflammatory Agents. Anti-Infective Agents. Antineoplastic Agents > QV 256 Antimalarials
QV Pharmacology > QV 38 Drug action.
QV Pharmacology > Drug Standardization. Pharmacognosy. Medicinal Plants > QV 771 Standardization and evaluation of drugs
WC Communicable Diseases > Tropical and Parasitic Diseases > WC 750 Malaria
Faculty: Department: Biological Sciences > Department of Tropical Disease Biology
Digital Object Identifer (DOI): https://doi.org/10.1128/AAC.02777-14
Depositing User: Mary Creegan
Date Deposited: 29 Aug 2014 10:34
Last Modified: 01 Jun 2018 13:39
URI: https://archive.lstmed.ac.uk/id/eprint/3830

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