Table 1 |
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Primary parameters to be included in WARN Pharmacokinetic Database |
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| Patient characteristics |
Antimalarial |
Methodology |
Pharmacokinetic parameters |
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| 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 |
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| Special Risk Group [2] |
Sample storage (temperature and duration) |
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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 |
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Barnes et al. Malaria Journal 2007 6:122 doi:10.1186/1475-2875-6-122 |
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