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. 2021 Jul 14;40(23):5096–5114. doi: 10.1002/sim.9113

TABLE B1.

Definition and value of the pharmacokinetics and pharmacodynamics (PK/PD) parameters used for the simulation study. Parameter estimate represents the fixed effect, and the coefficient of variation (CV) is the square root of the diagonal of the variance‐covariance matrix. These values are inspired by the parameters estimated on blinatumomab, 31 , 46 with a modification of Imax to observe cytokine mitigation after several administrations

Parameter Estimate (% CV) Unit Description
PK model Cl

1.36 (41.9)

L/h Clearance of elimination
V 3.4 (0) L Volume of distribution
PD model Emax 3.59 . 105 (14) pg/mL/h Maximum cytokine release rate
EC50 1.104 (0) ng/mL Drug exposure for half‐maximum release
H 0.92 (3) Hill coefficient for cytokine release
Imax 0.995 (0) Maximum inhibition of cytokine release
IC50 1.82·104 (12) pg/mL·h Cytokine exposure for half‐maximum inhibition
kdeg 0.18 (13) h−1 Degradation rate for cytokine
K 2.83 (36) Priming factor for cytokine release