Thursday 16 October, 2025
Objectives: Physiologically based pharmacokinetic (PBPK) models typically rely on parameter values that represent the mean of the study cohort or…
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Evaluating the benefit of individual patient data for physiologically based pharmacokinetic (PBPK) simulations
Thursday 16 October, 2025
Objectives: In this work, individualized physiologically-based pharmacokinetic (PBPK) models were built based on information from a clinical study in healthy…
Read moreThe use of optimal experimental design to inform a clinical trial on non-linearity of piperacillin clearance in critically ill patients.
Thursday 16 October, 2025
Objectives:Evidence on the linearity of piperacillin clearance at therapeutic plasma concentrations in patients in conflicting [1–5]. Non-linearity in piperacillin clearance…
Read moreImpact of Cytochrome P450 2D6, -3A4 and P-glycoprotein on Risperidone’s and 9-Hydroxyrisperidone’s plasma concentrations using a whole-body PBPK approach
Thursday 16 October, 2025
Objectives: The genetic polymorphism of Cytochrome P450 (CYP) 2D6 plays an influential role on the appearance of positive and adverse…
Read moreA joint ketamine and esketamine exposure-response model of MADRS score in major depressive disorder to enable informed trial design for candidate drugs with similar mode of action
Thursday 16 October, 2025
Objectives: Ketamine and esketamine have been shown to have positive effects on Montgomery-Åsberg Depression Rating Scale (MADRS), an endpoint commonly…
Read moreA model for evaluation of novel on-demand treatment of bleeding events in hemophilia subjects
Thursday 16 October, 2025
Objectives: Marzeptacog alfa (MarzAA) given subcutaneously (SC) was under development for on-demand treatment of episodic bleeds. The current standard-of-care (SoC)…
Read moreModel-informed dose selection in phase-3 trials for prophylactic treatment with dalcinonacog alfa in adult and pediatric hemophilia B patients
Thursday 16 October, 2025
Introduction: Factor IX dalcinonacog alfa (DalcA/CB 2679d) is being developed by Catalyst Biosciences to address the unmet need for medical…
Read morePhase-3 dose selection of marzeptacog alfa (activated) in children enabled by model-informed drug development techniques
Thursday 16 October, 2025
Objectives: Marzeptacog alfa (activated) (MarzAA), a novel engineered recombinant activated Factor VII is in clinical development for subcutaneous (SC) administration for…
Read moreModel-based approaches to prospectively power pediatric pharmacokinetic trials with limited sample size
Thursday 16 October, 2025
Introduction: In most drug development programs, sponsors are recommended to submit a pediatric plan with the purpose of identifying the…
Read moreDrug effect of clofazimine on persisting mycobacteria explain an unexpected increase in bacterial load from patients
Thursday 16 October, 2025
Introduction Clofazimine (CFZ) and pyrazinamide (PZA) are important components of recommended standard multi-drug treatments of TB. Paradoxically, in a Phase…
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