Table III.
Drug Characteristics Associated With Median Pediatric AUC Within 20% of Median Adult AUCa
| AUCchild/AUCadult ratio 0.8–1.2 N = 14 |
AUCchild/AUCadult ratio < 0.8 or > 1.2 N = 15 |
|
|---|---|---|
| Route of administration, No. (%) | ||
| Oral | 14 (100) | 9 (60) |
| Intravenous | 0 | 3 (20) |
| Both | 0 | 2 (13) |
| Other | 0 | 1 (7) |
| Route of elimination, No. (%) | ||
| Renal unchanged | 5 (36) | 2 (13) |
| Hepatic then renal | 2 (14) | 7 (47) |
| Hepatic then fecal | 7 (50) | 5 (33) |
| Other | 0 | 1 (7) |
| Indication, No. (%) | ||
| HIV | 9 (64) | 5 (33) |
| Intra-abdominal | 1 (7) | 1 (7) |
| Systemic | 3(21) | 5 (33) |
| Candidiasis | 0 | 2 (13) |
| Other | 1 (7) | 2 (13) |
| Drug class, No. (%) | ||
| Antiviral | 13 (93) | 8 (53) |
| Antibacterial | 0 | 5 (33) |
| Antifungal | 1 (7) | 2 (13) |
| Age range, No. (%) | ||
| Only 12–17 years | 4 (29) | 0 |
| > 2 years | 5 (36) | 5 (33) |
| > 28 days | 3 (21) | 8 (53) |
| > birth | 2 (14) | 2 (13) |
| Year approved, No. (%) | ||
| > 2008 | 8 (57) | 13 (87) |
| < 2008 | 6 (43) | 2 (13) |
| Approved indication, No. (%) | 13 (93) | 13 (87) |
Abbreviation: AUC, area under the concentration-time curve.
a
Mean values used if medians were unavailable