World Antimalarial Resistance Network (WARN) IV: Clinical pharmacology

Malaria Journal

Table 1 Primary parameters to be included in WARN Pharmacokinetic Database

Patient characteristics	Antimalarial	Methodology	Pharmacokinetic parameters
Malaria status [1]	Generic name	Sampling times (to include sampling on day of recurrence of parasitemia)	Day 7 concentration (median, IQR, range)
Age	Dose (total)	Sample Matrix (e.g. Venous blood, capillary blood, filter paper spot, breast milk, placenta, urine, saliva)	AUC (median, IQR, range)
Weight	Manufacturer	Assay method	Pharmacokinetic model
Gender	Route of administration	Assay Validity [3]
Sample size		Sample volume
Special Risk Group [2]		Sample storage (temperature and duration)

Footnotes to Table 1
Malaria status: Healthy volunteer; Asymptomatic Pf malaria; Intermittent preventive treatment (IPT); Uncomplicated Pf malaria; Moderately severe malaria; Uncomplicated hyperparasitaemia; Severe malaria; Uncomplicated P. vivax malaria; Prophylaxis; Other non-malaria disease.
2. Special Risk Group: Pregnancy (trimester); Infants; Pre-school; Co-morbid disease (HIV/AIDS; Tuberculosis; malnourished; obese).
3. Assay Validity: Retrospective data: Validity rating; Prospective data: pre-defined QC requirements

ISSN: 1475-2875