Benefits of a pharmacology antimalarial reference standard and proficiency testing program provided by the Worldwide Antimalarial Resistance Network (WWARN).
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.
Worldwide Antimalarial Resistance Network (WWARN).
Chris
C
Lourens
Worldwide Antimalarial Resistance Network (WWARN) Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand Centre for Tropical Medicine, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom.
Niklas
N
Lindegardh
Worldwide Antimalarial Resistance Network (WWARN) Division of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town, South Africa.
Karen I
KI
Barnes
Worldwide Antimalarial Resistance Network (WWARN) Centre for Tropical Medicine, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom.
Philippe J
PJ
Guerin
Worldwide Antimalarial Resistance Network (WWARN) Department of Genome Sciences, University of Washington, Seattle, Washington, USA.
Carol H
CH
Sibley
Worldwide Antimalarial Resistance Network (WWARN) Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand Centre for Tropical Medicine, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom.
Nicholas J
NJ
White
Worldwide Antimalarial Resistance Network (WWARN) Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand Centre for Tropical Medicine, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom joel@tropmedres.ac.
Joel
http://orcid.org/0000-0003-4566-4030
J
Tarning
D000962:Antimalarials / Q000493:pharmacokinetics / Q000494:pharmacology* / Q000592:standards*; D001711:Biotransformation; D004351:Drug Resistance; D007391:International Cooperation; D012015:Reference Standards; D015203:Reproducibility of Results
D000962:Antimalarials