Clinical Trials

❘❙❚■ Chapter 13 | Bioequivalence TrialsTable 3. Point estimates and 90% confidence intervals for the bioavailability ratio μ(T) / μ(R).Parameter Point estimate, θ Lower 90% CI, θ 1Upper 90% CI, θ θAUC 0–∞0.9796 0.9151 1.0485C max1.1237 0.9959 1.2681AUC 0–t0.9804 0.9155 1.0498T 1/20.9734 0.9165 1.0338λ 1.0273 0.9673 1.0911T max0.9450 0.6609 1.3511AUC 0–t= area under the concentration profile, ie, the amount of drug present in the blood, from 0 to t hours; AUC 0–∞= areaunder the curve from 0 to ∞ hours, ie, the total amount of drug present in the blood; C max= the peak concentration of thedrug in the body; T 1/2= the elimination half-life; T max= the time to reach the peak concentration of the drug from dosing;λ = the elimination rate constant; μ(R) = mean pharmacokinetic parameter for the reference product; μ(T) = meanpharmacokinetic parameter for the test product; θ = ratio of the geometric means between the test and reference products.Figure 4. Ratios of pharmacokinetic parameters and their 90% confidence intervals.1.40 –1.25 –1.20 –Ratio and its 90% CI1.00 –0.80 –0.60 – |AUC 0–∞|C max|AUC 0–t|T 1/2|λ|T max= point estimate; = upper limit of 90% CI; = lower limit of 90% CI; AUC 0–t= area under the concentration profilefrom 0 to t hours; AUC 0–∞= area under the curve from 0 to ∞ hours; C max= the peak concentration of the drug in thebody; T 1/2= the elimination half-life; T max= the time to reach the peak concentration of the drug from dosing;λ = the elimination rate constant.128