Table 1: Description of pharmacokinetics parameter.

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)