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. 2007 Sep 6;6:122. doi: 10.1186/1475-2875-6-122

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