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 3 Equivalence of C_max, AUC_0-t, and AUC_inf (BES)

Parameters	Geometric mean and ratio
Parameters	Test group (T)		Reference group (R)		T/R (%)	Individual variation among subjects CV (%)	90% CI %^a	Power (%)
C_max (μg/mL)	N = 44	55.80	N = 44	55.01	101.43	16.48	95.72 ~ 107.49	> 99.99
AUC_0-t (μg/mL•h)	N = 43	15,639.80	N = 43	16,077.68	97.28	16.52	91.71 ~ 103.18	> 99.99
AUC_inf (μg/mL•h)	N = 43	16,472.86	N = 43	16,976.75	97.03	17.95	91.03 ~ 103.43	> 99.96

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
AUC_0-t and AUC_inf for subject 017 (the reference group) were calculated by using the concentration data at the unplanned blood sampling point
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, CI Confidence interval, C_max Maximum serum concentration, CV Coefficient of variation
^ais the 90% CI for the geometric mean ratio of T/R

ISSN: 2050-6511