A phase I study comparing the biosimilarity of the pharmacokinetics and safety of recombinant humanized anti-vascular endothelial growth factor monoclonal antibody injection with Avastin® in healthy Chinese male subjects

Table 2 Summary of pharmacokinetic parameters

Note: Subject 014 and 041 lost the concentration data of more than three consecutive blood sampling points, causing the PK parameters AUC_0-t, AUC_inf, AUC_{_%Extra_ obs}, t_1/2, λ_Z, CL and Vd to become invalid, while C_max and T_max are valid. Subject 014 and 041 can be included in the pharmacokinetic parameter set (PKPS), while excluded from the BES
For subject 017, in the reference group, the infusion discontinued at 77 min and 27 s (about 1.291 h) after dosing, and blood collection was performed immediately (unplanned blood sampling), with the blood drug concentration of 38.8 μg/mL. The PK parameters presented in this table were calculated by including the concentration data of the unplanned blood sampling point. In addition, the PK parameters did not change when eliminating the concentration data of the unplanned blood sampling point, except the AUC_0-t and AUC_inf values
AUC_0-t Area under the serum concentration–time curve (AUC) from time zero to last quantifiable concentration, AUC_inf AUC from time zero to infinity, C_max Maximum serum concentration, CV Coefficient of variation, SD Standard deviation, T_max Time to C_max, T_1/2 Terminal half-life, Vd Apparent volume of distribution, λ_z terminal elimination rate constant
^aT_max is expressed by median (minimum, maximum)

ISSN: 2050-6511