Stability of Antimalarial Preparations.pptVIP

World Health Organization PQ: Artemisin-derivative issues No innovator FPP registered in the ICH region. Therefore No comparator available for: Pharmaceutical equivalence studies Bioequivalence studies The APIs and FPPs not official in the internationally used major pharmacopoeias WHO guides/SOPs apply to multisource FPPs. ICH guides therefore used Expression of Interest – oral dosage forms Artesunate* + Amodiaquine Artemether* + Lumefantrine* Artesunate* + Mefloquine Artesunate* + SP (sulphadoxine / pyrimethamine) Dihydroartemisin+Piperaquine Phosphate* * No comparator at the beginning * Hi