To ensure the quality of pharmacokinetic data, it is important that laboratories use proper reference standards. By utilising the same source of standards for all laboratories, it will be possible to minimise bias arising from poor quality reference standards. Also, by providing antimalarial drug standards from a central point, it will be possible to lower the cost of these standards.
How does it work?
Central storage
Reference standards will be stored at the central QA/QC Unit under optimal conditions — humidity, temperature, and stability data will be monitored continually to maximise usage of the material.
Sartorius SE2 Ultra Micro balance used to weigh
small quantities of antimalarial reference standards
Distribution
Reference standards will be aliquoted in small quantities (0.4000-2.000 mg) using an ultra-micro balance. Each participating pharmacology and in vitro laboratory will have the opportunity to receive shipments of a total amount of standard equal to approximately 20 mg per drug or metabolite per year. Participating pharmacology laboratories will also be supplied with small quantities of appropriate internal standards.
WWARN reference materials will be provided to laboratories that:
- participate in the QA/QC programme; and
- agree to sign relevant Material Transfer Agreements for the reference materials requested.
The QA/QC programme is based in the Pharmacology Department of the Mahidol-Oxford Research Unit, Faculty of Tropical Medicine, Mahidol University, in Bangkok, Thailand but operates as an independent entity. Initially, laboratories may freely participate in the QA/QC programme and receive standards without charge. In the future, WWARN plans to introduce a cost-recovery system to ensure the programme is sustainable whilst maintaining wide access to the services. Participants will be notified of any intended changes in advance.
| Antimalarial reference standards: | Internal standards: | Available soon: |
| Chloroquine Diphosphate Lumefantrine Mefloquine Hydrochloride Quinine Amodiaquine Pyrimethamine Sulfadoxine Azithromycin Dihydrate Artemisinin Dihydroartemisinin Piperaquine Artesunate Artemether Primaquine Desethylamodiaquine Halofantrine Desethyl chloroquine Pyronaridine Artemisone Carboxymefloquine Tafenoquine Desbutyl lumefantrine Doxycycline Otovaquone | N-Desethylamodiaquine-D5 Dihydroartemisinin-13CD4 Piperaquine-D6 Primaquine-13CD3 Amodiaquine-D10 Artesunate-D4 Artemether-13CD3 Piperaquine analog Amodiaquine analog Chloroquine analog Azithromycin-13CD3 Artemisone-D4 | Primaquine analog Carboxyprimaquine Carboxyprimaquine analog Lumefantrine analog Carboxyprimaquine-13CD3 Pyronaridine-13C2D4 Naphtoquine Naphtoquine-13C6 3-Hydroxy quinine |
Who is involved?
At this time, the WWARN QA/QC programme has registered four in vitro laboratories and ten pharmacology laboratories from around the world, and sent out a variety of antimalarial reference standards, metabolites and internal standards.
