Table 3.
Parameter | Parameter summary statisticsa | ||
---|---|---|---|
Predose concentration on cycle 1/day 15 | Predose concentration on cycle 2/day 15 | Predose concentration on day 15, cycles 1 and 2b | |
N | 32 | 30 | 38 |
Ctrough (ng/mL) | 89.4 (44) | 86.8 (40) | 90.1 (42) |
Ctrough, predose concentration during multiple dosing; N, number of patients evaluated with the steady‐state Ctrough.
The calculation required 2 conditions to be met for the steady state Ctrough evaluable criteria: (i) Ctrough following at least 7 consecutive days of palbociclib 125 mg daily dose without dosing interruption, and (ii) Ctrough to have the actual sampling time, which was ≤10% time deviation of the nominal time from 24 h after the last dose on day 14.
Geometric mean (geometric % coefficient of variation) for all.
Geometric mean of within‐patient mean Ctrough on cycles 1 and 2 on day 15.