Article Figures & Data
Figures
- Fig. 1.
Standard curve of C225 quantified by the Au NP–functionalized surface plasmon resonance assay and ELISA-based method in 20% monkey serum. The fitted curve was based on the four-parameter sigmoid model (mean ± S.D., n = 6).
- Fig. 2.
Signal responses of the baseline after each regeneration (A) and signal response of C225 at the first and 100th regeneration cycles at three different concentrations (B).
- Fig. 3.
Serum concentration–time profiles of C225 in rhesus monkeys during and after intravenous infusion administration at 7.5, 24, and 75 mg/kg. The symbols represent the observed data (mean ± S.D., n = 3).
Tables
Nominal Concentration (μg/ml) Observed Concentration (μg/ml) CV (%) Accuracy (%) 0.0125 0.0117 12.60 108.80 0.0132 0.0125 0.0146 0.0160 Intraday Assay Nominal Concentration of C225 0.025 0.4 1.6 (μg/ml) (μg/ml) (μg/ml) Observed concentration of C225 0.020 0.413 1.801 0.028 0.392 1.862 0.024 0.392 1.671 0.021 0.397 1.586 0.025 0.428 1.603 0.027 0.380 1.541 Mean 0.024 0.400 1.677 S.D. 0.003 0.017 0.128 Precision (%) 13.20 4.31 7.63 Accuracy (%) 96.67 100.08 104.83 Interday Assay Nominal Concentration of C225 0.025 0.4 1.6 (μg/ml) (μg/ml) (μg/ml) Observed concentration of C225 0.023 0.406 1.816 0.022 0.358 1.621 0.028 0.411 1.909 0.023 0.408 1.653 0.024 0.413 1.742 Mean 0.024 0.399 1.748 S.D. 0.002 0.023 0.118 Precision (%) 9.77 5.81 6.75 Accuracy (%) 96.0 99.8 109.26 - TABLE 4
Effects of different matrices on the binding of C225 to the sensor surface (mean ± S.D., n = 3)
Concentration of C225 (0.4 μg/ml) Observed Concentration (μg/ml, Mean ± S.D.) Precision (%) Accuracy (%) 50% human serum 0.432 ± 0.027 6.25 108.0 50% Sprague Dawley rat serum 0.442 ± 0.057 12.93 110.5 20% monkey serum containing 0.4 μg/ml chimeric recombinant anti-CD20 monoclonal antibody 0.424 ± 0.021 4.84 106.0 20% monkey serum containing 0.4 μg/ml human γ-globulin 0.439 ± 0.064 14.47 109.8 20% monkey serum containing 0.4 μg/ml chimeric recombinant her 2 antibody 0.458 ± 0.040 8.64 114.5 - TABLE 5
Pharmacokinetic parameters of C225 in rhesus monkeys after intravenous infusion (n = 3)
Low Dose 7.5 mg/kg Middle Dose 24 mg/kg High Dose 75 mg/kg AUC(0-t) (μg × h × ml−1) 16,390 ± 1201.8 51,453 ± 1199.8 263,091 ± 30,698 AUC(0-inf) (μg × h × ml−1) 16,396 ± 1202.7 51,526 ± 1198.8 26,345 ± 30,673 MRT (h) 105.11 ± 4.78 118.89 ± 1.19 152.84 ± 6.83 CL (ml × h−1 × kg−1) 0.459 ± 0.03 0.466 ± 0.01 0.29 ± 0.03 Vss (ml × kg−1) 48.26 ± 4.31 55.39 ± 0.94 43.85 ± 4.61 t1/2 (h) 33.15 ± 1.82 48.03 ± 0.69 55.72 ± 0.73 Cmax (μg × ml−1) 160.57 ± 25.66 1459.5 ± 52.27 3750.0 ± 138.42 AUC, area under the curve; CL, clearance; MRT, mean residence time.
Data Supplement
- Supplemental Figure -
Serum concentration-time profiles of Erbitux and C225 in rhesus monkeys during and after intravenous infusion administration at 7.5 mg/kg by SPR assay.
- Supplemental Figure -
