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 4 Sensitivity analysis of AUC_0-t and AUC_inf equivalence evaluation (mBES)

Parameters	Geometric mean and ratio
Parameters	Test group (T)		Reference group (R)		T/R (%)	Individual variation among subjects CV (%)	90% CI %^a	Power (%)
AUC_0-t (μg/mL•h)	N = 44	15,537.00	N = 43	15,477.67	100.38	22.54	92.72 ~ 108.68	99.71
AUC_inf (μg/mL•h)	N = 44	16,447.82	N = 43	16,518.34	99.57	20.29	92.69 ~ 106.97	99.95

Note: AUC_0-t and AUC_inf of subject 017 (the reference group) were calculated by removing the concentration data at the unplanned blood sampling point; AUC_0-t and AUC_inf of subjects 014 (the test group) and 041 (the reference group) not included in BES were re-incorporated, and AUC_0-t and AUC_inf of subject 070 (the reference group) were eliminated
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
^ais the 90% CI for the geometric mean ratio of T/R

ISSN: 2050-6511