. 2021 Aug 12;13(8):1244. doi: 10.3390/pharmaceutics13081244

Table 1.

Summary of specifications of selected models.

Model No.	Study	No. of Patients (Total No. of Samples)	Parameter Values and Covariate Relationships Included	IIV (CV)	Residual Variability
M1	FDA, 2008	646 adult patients (NA)	$CL / F (L / h) = 0.0127$ $V / F (L) = 9.39 + 0.126 \cdot (WT - 72))$ $ka (1 / h) = 0.027 FIX$	IIV-CL/F: 16.4% IIV-V/F: 35.1%	Prop = 31.6%
M2	Ternant D et al., 2015	65 adult CD patients (341)	$CL / F (L / h) = 0.0175 \cdot (1 + 4.5 \cdot AAA)$ $V / F (L) = 13.5$ $ka (1 / h) = 0.00625$	IIV-CL/F: 65% IIV-V/F: 48%	Add = 1.8 mg/L Prop = 16%
M3	Sharma S et al., 2015	189 pediatric CD patients (852)	$CL / F (L / h) = 0.0117 \cdot (1 + 1.08 \cdot AAA) \cdot {(WT / 45.2)}^{0.48}$ $V / F (L) = 4.75 \cdot {(WT / 45.2)}^{0.904}$ $ka (1 / h) = 0.00833$	IIV-CL/F: 21.1%	Add = 1.9 mg/L Prop = 7.1%
M4	Berends SE et al., 2018	96 adult CD patients (181)	$CL / F (L / h) = 0.0133 \cdot (1 + 3.14 \cdot AAA) \cdot (1 + 0.4 \cdot DOSING)$ $V / F (L) = 4.07$ $ka (1 / h) = 0.00833 FIX$	IIV-CL/F: 49.1%	Add = 1.02 mg/L Prop = 9%
M5	Vande Castelee et al., 2019	28 adult CD patients (185)	$CL / F (L / h) = 0.01375 \cdot (1 + 1.59 \cdot AAA) \cdot {(LBW / 47.8)}^{1.97}$ $V / F (L) = 7.8$ $ka (1 / h) = 0.0143$	IIV-CL/F: 32.6% IIV-V/F: 35.6% IIV-ka: 103.9%	Prop = −16.6%
M6	Sánchez-Hernández et al., 2020	104 adult IBD patients (303)	$CL / F (L / h) = 0.0157 \cdot {(BMI / 23.7)}^{1.11} \cdot (1 + 1.20 \cdot UDASC) \cdot (1 + 0.24 \cdot PEN) \cdot {(FCP / 74)}^{0.064}$ $V / F (L) = 11.2$ $ka (1 / h) = 0.00625 FIX$	IIV-CL/F: 23.2%	Prop = 21.7%

IIV: inter-individual variability; CV: coefficient of variation; CD: Crohn’s disease; IBD: Inflammatory Bowel Disease; WT: weight; AAA: antibodies against adalimumab; DOSING: adalimumab dosing regimen (0: every other week, 1: every week); UDASC: unexplained decline in adalimumab serum concentrations (0: NO, 1: YES); PEN: administration pen device during maintenance phase (0:40 mg, 1:80 mg); FCP: fecal calprotectin; add:additive error; prop: proportional error; NA: not available. The M numbers represent the selected models.