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. Author manuscript; available in PMC: 2016 Apr 1.
Published in final edited form as: Ther Drug Monit. 2015 Apr;37(2):236–245. doi: 10.1097/FTD.0000000000000131

Table 5.

Comparison of the percent of subjects achieving the therapeutic range Css of 600–900ng/mL for conventional dosing versus the model-based dosing at the time of first PK sampling.

Total No. of
Subjects		 Number (%) of
Subjects within
Goal Css
(600–900ng/mL		 Number (%) of
Subjects with
Css < 600ng/mL		 Number (%) of
Subjects with
Css > 900ng/mL
Conventional dosing1, 2 79 41 (52%) 33 (42%) 5 (6%)
Model-based algorithm3 21 17 (81%) 2 (9.5%) 2 (9.5%)
1

Excludes eleven subjects from the model development dataset (n=90) for which PK data from a test dose (0.5mg/kg) was given 3–4 days prior to the start of chemotherapy and used to predict the initial dose of busulfan therapy.

2

For patients weighing ≤12 kg, busulfan was initiated at 1.1 mg/kg/dose. An initial dose of 0.8 mg/kg/dose was used in children weighing greater than 12 kg. PK sampling was collected with the first dose of busulfan.

3

Twenty-one subjects that were prospectively dosed on the model-based algorithm (validation data set). PK sampling was conducted with dose 3 of busulfan.