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The reduced sample size of GD patients and collected observations per individual may represent a limitation of the proposed population PK model as it could increase the risk of biased estimation of individual parameters. 64 The low incidence of GD partially explains the limited dataset, although it is also remarkable that the duration of the PK and efficacy study has allowed detection of a decrease over time of CL_{step 1}. Regarding this, a 2.32-fold increase in CL was estimated during the first 14 days of treatment, which helps to characterize the steady-state levels of GBA₁.

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