|
Cell Experiment
|
| Cell lines |
PBMCs |
| Preparation method |
Add ipilimumab at the initiation of ATC expansion cultures from healthy donors at various concentrations ranging from 0 to 50 μg/mL. ATC(activated T cells) are harvested on day 14, armed with EGFRBi or CD20Bi, and co-cultured at 25:1 E:T(effector:target) ratio for 18 hours with EGFR positive pancreatic cancer cell line (COLO356/FG) or 4 hours with CD20 positive Burkitt's lymphoma cell line (Daudi) for cytotoxicity assay. BiAb-mediated tumor specific cytotoxicity is measured by 51Cr release assay. |
| Concentrations |
0, 0.5, 5.0, and 50 μg/mL |
| Incubation time |
14 days |
|
Animal Experiment
|
| Animal models |
Purpose-bred cynomolgus monkeys |
| Formulation |
Saline |
| Dosages |
3 mg/kg or 10 mg/kg |
| Administration |
i.v. |
Conversion of different model animals based on BSA (Value based on data from FDA Draft Guidelines)
| Species |
Mouse |
Rat |
Rabbit |
Guinea pig |
Hamster |
Dog |
| Weight (kg) |
0.02 |
0.15 |
1.8 |
0.4 |
0.08 |
10 |
| Body Surface Area (m2) |
0.007 |
0.025 |
0.15 |
0.05 |
0.02 |
0.5 |
| Km factor |
3 |
6 |
12 |
8 |
5 |
20 |
Animal A (mg/kg) = Animal B (mg/kg) multiplied by Animal B Km
Animal A Km
For example, to modify the dose of resveratrol used for a mouse (22.4 mg/kg) to a dose based on the BSA for a rat, multiply 22.4 mg/kg by the Km factor for a mouse and then divide by the Kmfactor for a rat. This calculation results in a rat equivalent dose for resveratrol of 11.2 mg/kg
