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