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. 2014 Aug 21;78(3):477–487. doi: 10.1111/bcp.12355

Table 2.

Mean (± SD) denosumab PK parameters after multiple dose subcutaneous administration of 30, 120, and 180 mg Q4W

Dose 1 Dose 3 Dose 5 Dose 6
Dose (mg) C1 week (ng ml−1) AUC(0,τ) (ng ml−1 day) C2 weeks (ng ml−1) AUC(0,τ) (ng ml−1day) AR1 C2 weeks (ng ml−1) AUC(0,τ) (ng ml−1 day) AR2 C2 weeks (ng ml−1) t1/2,z (day)
30 n 33 33 39 39 39 39 34 19
Mean 3190 67900 7300 152000 2.24 7830 168000 2.47 6090 26.1
SD 1390 28600 3940 81300 2.84 4320 80100 2.80 3360 10.1
%CV* 43.4 42.1 54.0 53.4 1.27 55.2 47.8 1.14 55.1 38.8
120 n 34 34 36 36 35 35 35 29
Mean 13500 287000 22800 539000 1.88 27100 723000 2.52 20500 28.8
SD 6140 130000 9440 215000 1.66 14500 684000 5.26 13500 9.5
%CV* 45.5 45.3 41.4 40.0 0.883 54.7 94.5 2.09 65.8 32.9
180 n 36 36 39 39 38 38 33 28
Mean 22000 478000 46300 1030000 2.15 45300 1090000 2.27 38200 34.8
SD 7300 154000 20300 381000 2.48 15300 356000 2.31 13000 12.4
%CV* 33.2 32.1 43.9 37.1 1.16 33.8 32.7 1.02 34.0 35.6
*

Percent coefficient of variation = (SD/Mean) × 100. SD, standard deviation; PK, pharmacokinetics; C1 week, serum concentration 1 week post-dose; C2 weeks, serum concentration 2 weeks post-dose; AUC(0,τ), area under the concentration–time curve from time zero to day 84; t1/2,z, terminal phase half-life; accumulation ratio (AR1) = (AUC(0,τ), dose 3)/(AUC(0,τ), dose 1); accumulation ratio (AR2) = (AUC(0,τ), dose 5)/(AUC(0,τ), dose 1).