Abstract
Comprehensive assessment of antimalarial drug resistance should include measurements of antimalarial blood or plasma concentrations in clinical trials and in individual assessments of treatment failure so that true resistance can be differentiated from inadequate drug exposure. Pharmacometric modeling is necessary to assess pharmacokinetic-pharmacodynamic relationships in different populations to optimize dosing. To accomplish both effectively and to allow comparison of data from different laboratories, it is essential that drug concentration measurement is accurate. Proficiency testing (PT) of laboratory procedures is necessary for verification of assay results. Within the Worldwide Antimalarial Resistance Network (WWARN), the goal of the quality assurance/quality control (QA/QC) program is to facilitate and sustain high-quality antimalarial assays. The QA/QC program consists of an international PT program for pharmacology laboratories and a reference material (RM) program for the provision of antimalarial drug standards, metabolites, and internal standards for laboratory use. The RM program currently distributes accurately weighed quantities of antimalarial drug standards, metabolites, and internal standards to 44 pharmacology, in vitro, and drug quality testing laboratories. The pharmacology PT program has sent samples to eight laboratories in four rounds of testing. WWARN technical experts have provided advice for correcting identified problems to improve performance of subsequent analysis and ultimately improved the quality of data. Many participants have demonstrated substantial improvements over subsequent rounds of PT. The WWARN QA/QC program has improved the quality and value of antimalarial drug measurement in laboratories globally. It is a model that has potential to be applied to strengthening laboratories more widely and improving the therapeutics of other infectious diseases.
Highlights
Worldwide Antimalarial Resistance Network (WWARN)a‡; Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailandb; Centre for Tropical Medicine, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdomc; Division of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town, South Africad; Department of Genome Sciences, University of Washington, Seattle, Washington, USAe
All laboratories used established extraction methods followed by liquid chromatography-mass spectrometry (LC-MS) or LC-UV detection
Laboratories were free to select their preferred assay method in order to have their performance assessed in the proficiency testing program
Summary
Pharmacometric modeling is necessary to assess pharmacokinetic-pharmacodynamic relationships in different populations to optimize dosing. To accomplish both effectively and to allow comparison of data from different laboratories, it is essential that drug concentration measurement is accurate. The RM program currently distributes accurately weighed quantities of antimalarial drug standards, metabolites, and internal standards to 44 pharmacology, in vitro, and drug quality testing laboratories. When pharmacokinetic data are assessed, it is necessary to differentiate between true patient population differences and differences in accuracy between assay methods or laboratories. The WWARN laboratory quality assurance/quality control (QA/QC) program (1) provides access to high-quality reference standards, eliminates weighing errors, and supports pharmacology, in vitro, and drug quality testing laboratories, including those in low-resource settings, to achieve high-quality data. This report describes the WWARN antimalarial drug QA/QC program operation and performance
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