Table 3.
Secondary PK and PD analyses
| Parameter | N | Sandoz proposed biosimilar pegfilgrastim | Reference pegfilgrastim |
|---|---|---|---|
| PK (Serum concentration) | |||
| tmax (h), median (range) | 169 | 12.0 (4.1–60.0) | 12.0 (8.0–48.0) |
| t½ (h), mean (SD) | 168 | 17.9 (18.9) | 18.2 (20.4) |
| PD (ANC) | |||
| tmax, E (h), median (range) | 169 | 60.0 (36.0–108.0) | 60.0 (24.0–108.3) |
N, number of subjects in treatment group; PK, pharmacokinetics; tmax, time to the maximum observed serum concentration; t½, elimination half‐life; SD, standard deviation; PD, pharmacodynamics; ANC, absolute neutrophil count; tmax,E, time to the maximum effect attributable to the investigational medicinal product