ArticleBMJ open2025
Development and validation of an innovative approach to estimating FVIII levels and designing personalised doses in the prophylactic treatment of haemophilia A: based on the principle of the two-compartment model.
Article in BMJ open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
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10 authors.
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Abstract
objectiveTo predict the level at a specified time and design personalised dosing, we proposed a method (Method 1) for estimating coagulation factor VIII (FVIII) pharmacokinetic (PK) parameters using 4 levels within 48 hours after administering a test dose.
designA retrospective study based on virtual populations and real patients.
settingA comprehensive hospital in China.
participantsVirtual populations generated by Monte Carlo simulations and retrospectively collected real patient data.
methodsPK profiles of FVIII after dosing in the virtual populations were generated from a published population PK model coupled with Monte Carlo simulation. The simulated coagulation factor levels were considered as the reference (C
resultsIn the adult group, the maximum mean deviations for Methods 1 and 2 were 0.43% (±0.35%) and -36.31% (±6.67%), with corresponding maximum root mean square errors (RMSE) of 0.12% and 28.44%, respectively. For the paediatric group, the maximum mean deviations for Methods 1 and 2 were 0.13% (±0.25%) and -34.27% (±6.74%), with maximum RMSEs of 0.05% and 25.33%, respectively. In three actual patients, mean deviations using Method 1 were 0.32%, 1.34% and 0.24%. Mean deviations using Method 2 were 13.37%, -16.86% and 56.66%.
conclusionThe proposed method for estimating FVIII PK parameters and levels demonstrates high accuracy and has the potential for precision dosing.
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