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- W3186076064 abstract "Abstract Background the study aimed to predict bendamustine pharmacokinetics in paediatric patients by employing physiological-based pharmacokinetic (PBPK) model that considers age-dependent physiological maturity. Methods Using PK-Sim, a paediatric PBPK model was constructed based on a validated PBPK adult model using the recommended paediatric dose at 120 mg/m 2 bendamustine intravenous (IV) infusion for 60 minutes and age-dependent mechanistic scaling. Parameter optimisation was done based on model fitting to the observed in vivo population pharmacokinetic (PK) data using the visual predictive check. The final paediatric PBPK model was extrapolated to various paediatric age categories (term newborn, infant, toddler, preschool, school-age, adolescent) for PK estimate and comparisons. The PBPK paediatric model was compared with the adult model, and PK comparisons were made for different age categories with the reference paediatric model. Results The model estimated a bendamustine fraction unbound of 4% in a paediatric patient. Renal clearance, biliary clearance and total hepatic clearance in a typical child were 1.38 mL/min/kg, 0.02 mL/min/kg and 13.76 mL/min/kg respectively. The paediatric model was comparable to the adult model. Compared to a typical child, a term newborn has the highest estimated maximum plasma concentration (C max ) and systemic exposure (AUC 0-24h ), which were 1.24-fold respectively. Clearance in term newborn and infant were 1.4-1.5-fold higher than a typical child. Conclusions We developed a bendamustine PBPK model for a paediatric patient with relapsed/refractory Acute Lymphocytic Leukaemia (ALL) and Acute Myeloid Leukaemia (AML). The current model may be useful to estimate systemic exposure in paediatric for various age categories in different settings. More in vivo studies are needed in paediatric patients to challenge the robustness of this model." @default.
- W3186076064 created "2021-08-02" @default.
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- W3186076064 date "2021-07-19" @default.
- W3186076064 modified "2023-09-26" @default.
- W3186076064 title "Development of A Physiological-Based Pharmacokinetic Model to Predict Bendamustine Exposure in Paediatric Patients" @default.
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- W3186076064 doi "https://doi.org/10.21203/rs.3.rs-620431/v1" @default.
- W3186076064 hasPublicationYear "2021" @default.
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