Blood |
Cmax
|
Maximum observed blood drug concentration, determined directly from individual concentration-time data |
Observed value |
Tmax
|
Time to maximum blood concentration, determined directly from individual concentration-time data |
Occurrence of observed Cmax
|
Clast
|
Last quantifiable drug concentration, determined directly from individual concentration-time data |
Observed value |
Tlast
|
Time of last quantifiable drug concentration, determined directly from individual concentration-time data |
Occurrence of observed Clast
|
AUC0–t
|
Area under the blood concentration-time curves from time 0 to the time of the last quantifiable concentration |
Linear trapezoidal rule AUC0–t = δt × (C1 + C2)/2 |
AUC0–∞
|
Area under the blood concentration-time curve from time 0 to infinity |
AUC0–∞ = AUC0–t + Clast/λz
|
%AUCext
|
Percentage of area under the curve extrapolated from time t to infinity |
100 × (1 − [AUC0–t/AUC0–∞]) |
λz
|
Terminal phase elimination rate constant |
Linear regression of the terminal linear portion of the log concentration versus time curve |
t½
|
Apparent terminal elimination half-life |
t½ = ln(2)/λz
|
CL/F
|
Apparent systemic clearance following nonintravenous (e.g., oral) administration, where F is the bioavailability |
CL/F = Dose/AUC0–∞
|
Vz/F
|
Apparent volume of distribution following nonintravenous (e.g., oral) administration, where F is the bioavailability |
Vz/F = Dose/(AUC0–∞ × λz) |
Urine |
Ae |
Amount of drug excreted unchanged into urine per collection interval |
Ae = urine concentration × volume |
Total Ae |
Cumulative amount of drug excreted unchanged into urine over the entire collection interval |
Sum of Ae |
Fe% |
Percentage of dose excreted in urine per collection interval |
Fe% = Ae/Dose × 100 |
Total Fe% |
Total percentage of dose excreted in urine over the entire collection interval |
Fe% = Total Ae/Dose × 100 |
CLr
|
Renal clearance |
CLr = Total Ae/AUC0–∞
|
CLnr
|
Nonrenal clearance of drug from blood |
CLnr = CL/F − CLr
|
CLratio
|
Ratio of renal clearance to systemic clearance |
CLratio = CLr/(CL/F) |
Tmax_Rate
|
Midpoint of the collection interval associated with the maximum observed excretion rate |
Observed value |
Max_Rate |
Maximum observed excretion rate, at time Tmax_Rate
|
Observed value |