Additional file 1:

Short report by the sponsor Dafra Pharma nv/sa. A relative bioavailability study for Fixed Dose Combination (FDC) comparing Coartem Tablets (containing Artemether 20 mg and Lumefantrine 120 mg) of Novartis Pharmaceuticals Limited, EU with Co-Artesiane^® dry powder for suspension (containing β-Artemether 360 mg and Lumefantrine 2160 mg in 45.6 g dry powder for suspension of 120 ml) of Dafra Pharma NV, Belgium in 42 + 6 healthy adult human subjects.

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Additional file 2:

Discussion Dosing Al. Following the WHO guidelines for the treatment of malaria (WHO, 2006, pages 23–24) the recommended dose for artemether/lumefantrine tablets (Coartem^®) when used for children between 5 and 14 kg is 1 tablet at time 0 h and 1 tablet at time 8 h followed by two tablets a day for two days (24, 36, 48 and 60 h). Calculated as mg artemether per kg body weight (bw), this means that for a child of 5 kg a dose of 8 mg artemether/kg per day spread over two doses is given. Evidence that this high dose of more than 4 mg/kg bw of artemether is needed for small babies (± 5 kg) is scanty or non existent. Moreover, this "overdosing" situation is in contrast with the adult dose of 8 pills a day divided over two intakes. This means that an adult of 50 kg takes a dose of 3.2 mg/kg of artemether and an adult of 75 kg takes one of 2.1 mg/kg per day. There is no dose finding study published that we could find to justify this variation in dosing.

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