Table 4.

Combined species PK parameter estimates for mAbs with linear CL.

Combined Datasets		Tg32 Mouse, Cyno and Human (n=27 mAbs)		Cyno and Human (n=23 mAbs)		Tg32 Mouse and Human (n=23 mAbs)
Parameter	Unit	Value (95%-CI)	RSE (%)	Value (95%-CI)	RSE (%)	Value (95%-CI)	RSE (%)
CL	mL/h/kg	0.16 (0.15–0.16)	2.86	0.15 (0.14–0.16)	2.90	0.15 (0.14–0.16)	2.97
V1	mL/kg	45.19 (44.08–46.31)	1.26	45.89 (44.75–47.03)	1.27	46.41 (45.26–47.56)	1.26
Q	mL/h/kg	0.28 (0.25–0.31)	5.06	0.29 (0.26–0.32)	5.08	0.28 (0.25–0.31)	4.97
V2	mL/kg	30.81 (28.15–33.46)	4.40	31.14 (28.61–33.68)	4.15	32.17 (29.31–35.04)	4.55
CL: α	—	0.89 (0.87–0.91)	1.16	0.81 (0.77–0.85)	2.22	0.90 (0.88–0.92)	1.24
V1: β	—	0.98 (0.97–0.99)	0.54	1.04 (1.02–1.06)	0.87	0.97 (0.96–0.98)	0.55
Q: γ	—	0.67 (0.63–0.71)	2.87	0.57 (0.48–0.67)	8.36	0.67 (0.64–0.70)	2.19
V2: δ	—	0.95 (0.93–0.98)	1.28	1.07 (1.03–1.11)	2.02	0.93 (0.91–0.94)	0.84
IIV CL	—	0.47 (0.43–0.52)	4.61	0.45 (0.41–0.50)	4.64	0.47 (0.42–0.52)	5.00
COV CL-V1	—	0.08 (0.06–0.10)	11.25	0.08 (0.06–0.10)	10.82	0.08 (0.07–0.10)	10.83
IIV V1	—	0.11 (0.09–0.12)	6.26	0.10 (0.09–0.11)	6.44	0.10 (0.08–0.11)	6.31

CL: clearance from the central compartment, V1: volume of the central compartment, Q: inter-compartment distribution clearance, V2: volume of the peripheral compartment. %RSE: relative standard error, calculated as: standard error of estimation / estimated value x 100% 95% CI: 95% confidence interval calculated from standard error. α, β, γ, and δ: allometric exponents estimated for CL, V1, Q and V2 respectively, to scale from the preclinical species to human using the equation: $Y_{human predicted}= Y_{species}*{\left(\frac{B{W}_{human}}{B{W}_{species}}\right)}^{\alpha , \beta ,\gamma or \delta }$

IIV: inter individual variability. COV CL-V1: covariance between clearance and volume. Residual errors per compound are shown in Supplementary Table 2. For each combined dataset the total ’n’ includes n=18 mAbs with clinical data, n=23 mAbs with cyno data and n=11 mAbs with Tg32 mouse data.