Table 5.
Population PK parameters for nelfinavir and M8 from the original dataset and following the bootstrap validation
| Final model original dataset | Bootstrap* | ||
|---|---|---|---|
| Parameter | Mean (CV%) | Median | 2.5th−97.5th percentiles |
| Structural model | |||
| ka (h−1) | 0.67 (23) | 0.81 | 0.11–1.73 |
| tlag (h−1) | 0.87 (2) | 0.90 | 0.31–2.26 |
| V (l) | 557 (25) | 632 | 66–1650 |
| CLNm→No/F (l h−1) | 39.5 (6) | 38.1 | 31–45 |
| CLNm→No/F and V, θDEL | 1.92 (20) | 1.95 | 1.23–3.05 |
| CLNm→No/F, θBW (on DEL) | 2.81 (34) | 3.25 | 1.49–6.06 |
| CLNm→M8m/F (l h−1) | 0.77 (10) | 0.86 | 0.34–4.35 |
| kM8m→M8o (h−1) | 3.41 (14) | 3.93 | 1.51–20.4 |
| kM8m→M8o, θPREG | 0.67 (31) | 0.71 | 0.27–1.29 |
| kM8m→M8o, θBW | 1.41 (25) | 1.39 | 0.53–2.26 |
| kM8m→M8o, θNNRTI | 1.48 (38) | 1.32 | 0.53–2.98 |
| CLNm→Nc/F (l h−1) | 0.058 (48) | 0.08 | 0.01–0.71 |
| kNc→Naf (h−1) | 0.23 (48) | 0.34 | 0.03–3.02 |
| kNaf→No (h−1) | 0.36 (43) | 0.53 | 0.06–5.09 |
| kM8m→M8c (h−1) | 0.35 (24) | 0.30 | 0.06–0.53 |
| kM8c→M8af (h−1) | 0.59 (18) | 0.55 | 0.10–0.83 |
| kM8af→M8o (h−1) | 0.49 (8) | 0.47 | 0.10–0.71 |
| Statistical model | |||
| σNELFI MOTHER (mg l−1) | 1.07 (16) | 1.06 | 0.85–1.26 |
| σ M8 MOTHER (mg l−1) | 0.24 (25) | 0.24 | 0.17–0.30 |
| σNELFI FETUS/CORD (mg l−1) | 0.09 (38) | 0.09 | 0.06–0.13 |
| σ M8 FETUS (mg l−1) | 0.03 (56) | 0.06 | 0.02–0.08 |
| σM8 CORD (mg l−1) | 0.12 (68) | 0.13 | 0.01–0.25 |
| ω(V) (%) | 132 (36) | 157 | 114–327 |
| ω(CLNm→No/F) (%) | 53 (16) | 56 | 46–73 |
| ω(kM8m→M8o/F) (%) | 74 (24) | 63 | 42–84 |
| ω(CLNm→Nc) (%) | 34 (58) | 37 | 14–57 |
| ω(kM8m→M8c) (%) | 76 (32) | 83 | 46–139 |