Blood Clearance Parameters for 111In-Epratuzumab and 90Y-Epratuzumab IgG
| Monoexponential curve-fit parameters | Measured | Predicted | ||
|---|---|---|---|---|
| 111In-Epratuzumab IgG pretherapy injection | 90Y-Epratuzumab IgG therapy injection | 90Y-Epratuzumab IgG from 111In-epratuzumab | ||
| t1/2, effective (h) | ||||
| Mean ± SD | 36.1 ± 7.9 | 35.2 ± 7.0 | 34.8 ± 7.5 | |
| Range | 18.0–45.7 | 20.0–47.6 | 17.7–43.9 | |
| n | 25 | 22 | 22 | |
| RT, effective (h/L) | ||||
| Mean ± SD | 10.6 ± 2.8 | 8.8 ± 2.9 | 10.1 ± 2.9 | |
| Range | 4.5–14.6 | 4.5–15.1 | 4.3–14.1 | |
| n | 25 | 22 | 22 | |
| t1/2, biologic (h) | ||||
| Mean ± SD | 85.0 ± 34.0 | 88.9 ± 37.2 | ||
| Range | 24.0–139.5 | 29.7–183.9 | NA | |
| n | 25 | 22 | ||
| Bioequivalency evaluation measurement | Anti-logarithm of mean difference | 90% confidence interval | ||
|---|---|---|---|---|
| RT, effective (111In vs. 90Y measured) | 0.93282 | 0.82851 | 1.05003 | |
| RT, effective (90Y predicted from 111In vs. 90Y measured) | 1.19152 | 1.11995 | 1.26736 | |
| t1/2, biologic (111In vs. 90Y measured) | 0.87036 | 0.81715 | 0.92704 | |
NA = not applicable.
Predicted t1/2 for 90Y-epratuzumab data was derived by assuming biologically derived data for 111In-epratuzumab and 90Y-epratuzumab were identical. Using this assumption, 90Y-effective data were predicted from 111In-epratuzumab data.