This presentation describes the monitoring of the safety and efficacy of the new fixed-dose antimalarial formulation ASAQ (artesunate + amodiaquine): rationale, potential safety risks to be quantified, missing information, clinical trials, and monitoring after implementatation of treatment. Objectives are: in the short term to design innovative says of collecting good data on ASAQ; in the medium term to contribute to the design of risk management plans for future new antimalarials; and in the longer term: to contribute to strengthening of pharmacovigilance systems in Africa.
Presentation from ‘Pharmacovigilance of new antimalarials in the field: challenges and opportunities’. Symposium from American Society of Tropical Medicine and Hygiene 58th Annual Meeting, Washington, DC, USA, 20 November 2009.
The artesunate-amodiaquine fixed-dose combination field monitoring program: Objectives, methods, and first results from Liberia and Senegal.