TABLE 5.
Dependent variable | Model variable | Estimate (β1) | Lower CIa | Upper CIa | Rho1b |
---|---|---|---|---|---|
ln(Cmax) | ln(dose) | 0.7449 | 0.5613 | 0.9285 | 1.9266 |
ln(AUClast) | ln(dose) | 0.9878 | 0.8098 | 1.1658 | 4.5390 |
ln(AUCinf) | ln(dose) | 1.0791 | 0.9242 | 1.2340 | 3.4200 |
90% confidence intervals (lower and upper).
High/low dose ratio in which dose proportionality can be demonstrated definitely, relative to the lowest dose in the analysis data set. Rho1 was calculated as Rho1 = (ϴH) ^ (1/max(1 − lower, upper − 1)), in which ϴH = 1.333.
Power model: ln(PK) = ln(β0) + β1 × ln(dose) + ε, where PK is the pharmacokinetic parameter tested, ln(β0) is the y-intercept, β1 is the slope, and ε is an error term.