Implementation of a reference standard and proficiency testing programme by the World Wide Antimalarial Resistance...

Area of Science:

• Pharmacology
• Global Health
• Analytical Chemistry

Background:

• The Worldwide Antimalarial Resistance Network (WWARN) aims to ensure effective malaria drug treatments.
• Defining drug exposure-effect relationships for antimalarials is critical but hindered by data comparability issues across laboratories.
• Accurate assay methods are essential to explain pharmacokinetic variability and ensure reliable safety and efficacy data.

Purpose of the Study:

• To describe the external quality assurance process developed by the WWARN Pharmacology module.
• To establish a framework for comparable and reliable antimalarial drug concentration data.
• To improve the quality of pharmacokinetic data shared within WWARN.

Main Methods:

• Implementation of a two-component quality assurance/quality control (QA/QC) program.
• Proficiency testing: Distributing spiked human plasma samples to bioanalytical laboratories.
• Certified reference standard program: Supplying certified antimalarial standards to laboratories.

Main Results:

• The proficiency testing program allows laboratories to assess and improve their drug analysis capabilities.
• The certified reference standard program ensures consistent quality and minimizes bias from reference materials.
• Centralized provision of standards aims to reduce costs for participating laboratories.

Conclusions:

• The QA/QC program enhances the quality and comparability of antimalarial pharmacokinetic data.
• Standardized reference materials and proficiency testing improve data reliability for malaria treatment research.
• This initiative supports WWARN's objective of providing effective and safe antimalarial drug treatments worldwide.