No |
Abbreviated Parameter (unit measurement) |
Definition |
PRIMARY OUTCOMES |
1 |
CL/F (l/h) |
It is the apparent elimination clearance |
2 |
Vc/F (l) |
It is the apparent volume of distribution of the central compartement |
3 |
Q1/F (l/h) |
These are the inter-compartment clearances between the central and the peripheral compartment |
4 |
Q2/F (l/h) |
5 |
VP1/F (l) |
These are the apparent volumes of distribution of the peripheral compartments |
6 |
VP2/F (l) |
7 |
MTT (h) |
It is the mean transit time of the absorption |
8 |
Number of transit compartments |
It is the number of transit compartments used in the absorption model |
9 |
F |
It is the relative bioavailability |
10 |
RUV |
It is the variance of the unexplained residual variability |
COVARIATE RELATIONSHIP |
11 |
Scale |
It is the difference between venous and capillary predictions |
12 |
MF50 (years) |
It is the maturation age (years) to reach 50% of the full elimination clearance |
13 |
HillMF
|
It is the hill function in the maturation equation, with an upper limit of 10 |
14 |
DoseF
|
It represents the increase in relative bioavailability between dosing occasion |
SECONDARY OUTCOMES |
15 |
Cmax (ng/ml) |
It is the maximum concentration |
16 |
Tmax (h) |
It is the time after dose to reach the maximum concentration |
17 |
T1/2 (d) |
It is the terminal elimination half life |
18 |
AUC∞ (h x ng/ml) |
It is the area under the concentration-time curve from time 0 to infinity |
19 |
Day 7 concentration |
It is the venous plasma concentration at day 7 after dosing |
ADDITIONAL INFORMATION |
20 |
Coefficient of variation for inter-individual variability (IIV) |
These are calculated as 100 x (e variance -1)1/2
|
21 |
Inter-occasion variability (IOV) |