Table 2.
Final Full Model |
|||
---|---|---|---|
Parameter | Estimate | 95% CI | RSE (%) |
Typical values | |||
CL/F, L/h | 3.53 | 3.47–3.58 | 0.8 |
Vc/F, L | 33.4 | 32.9–33.9 | 0.8 |
DOSEF (1,500 mg) | 0.80 | 0.78–0.81 | 0.9 |
DOSEF (2,000 mg) | 0.70 | 0.66–0.73 | 2.4 |
MTT, h | 1.31 | 1.24–1.36 | 2.0 |
Covariate effects | |||
% Increase in FEMALEF | 16.3 | 13.8–18.7 | 6.3 |
% Decrease in RACEMTT | 41.8 | 28.9–49.2 | 8.4 |
% Decrease in FOODMTT | 51.9 | 47.0–55.9 | 3.7 |
IIV | |||
%CV* for IIV CL/F | 25.1 | 23.8–26.3 | 2.1 |
%CV* for IIV of MTT | 95.8 | 91.7–98.6 | 1.7 |
Residual variability | |||
SD of additive residual error | 0.47 | 0.38–0.56 | 8.6 |
% Increase in residual error | 17.5 | 16.3–18.6 | 3.2 |
Definition of abbreviations: CI = confidence interval; CL/F = apparent clearance; CV = coefficient of variation; DOSEF (1,500 mg) = apparent bioavailability of 1,500-mg dose; DOSEF (2,000 mg) = apparent bioavailability of 2,000-mg dose; FEMALEF = bioavailability for female sex; FOODMTT = mean transit time at fasting state; IIV = interindividual variability; MTT = mean transit time; RACEMTT = mean transit time for Asian relative to Black and mixed race; RSE = relative SE; Vc/F = apparent volume of distribution of central compartment.
MTT = (1 + FOODMTT × FOOD) × (1 + RACEMTT × RACE), where FOOD = 0 or 1 for 6-month control or two 4-month regimens, respectively; RACE = 0 or 1 for Black/mixed race or Asian race. F = (1 + FEMALEF × FEMALE) × (DOSEF), where FEMALE = 0 or 1 for male or female; DOSEF was estimated separately for higher doses (e.g., 1,500 or 2,000 mg) assuming reference 1,000 mg with apparent bioavailability of 1.
Defined as %CV = 100 × sqrt[exp(ω2) − 1], where ω2 is the variation of the interindividual random effects.