Table 2.
Steps for building an antibody operating space map, from benchmark PK simulation to alternative‑regimen dose matching and visualization
| Step | Description | Example |
|---|---|---|
| 1 | Define benchmark regimen | 1000 mg IV |
| 2 | Simulate benchmark PK across schedules | QW, Q2W, Q4W, Q8W, Q12W, Q24W |
| 3 | Select matching PK metric | Cavg, ss |
| 4 | Specify alternative regimen | SC + rHuPH20 |
| 5 | Solve for alternative-regimen, metric-matched doses | 1000 mg Q4W → 340 mg QW |
| 6 | Convert doses to volumes | 340 mg ÷ 150 mg/mL = 2.3 mL |
| 7 | Apply volume-based color bands | 0–2.25 mL; 2.25–10 mL; 10–20 mL; >20 mL |
| 8 | Overlay benchmark and alternative PK profiles | IV and SC + rHuPH20 PK curves overlaid |
| 9 | Interpret regimen trade-offs | ↓ Cmax, ss; ↑ Cavg, ss; ↓ frequency; etc. |