Poster: Methodology - Other topics

Improving the performances of clinical trial simulations in Simulo using compiled code

Thursday 16 October, 2025

Objectives: In R, dynamic linked models (DLL’s) have been proved to increase the speed of repetitive tasks, such as clinical…

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A technical concept of automatic PBPK platform (re-)qualification in the Open Systems Pharmacology Suite (PK-Sim® and MoBi®)

Thursday 16 October, 2025

Objectives: The recently issued draft guideline on physiologically-based pharmacokinetic modeling (PBPK) by the European Medicines Agency (EMA) [1] demands the…

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A comparison of two model reduction methodologies for a QSP bone biology system with denosumab dosing.

Thursday 16 October, 2025

Introduction:The increasing use of quantitative systems pharmacology (QSP) and physiologically-based pharmacokinetic (PBPK) modelling in drug development has caused modellers to…

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Considerations for the application of PBPK to optimize drug therapies in special populations: The Open Systems Pharmacology solutions

Thursday 16 October, 2025

Objectives: Multiple factors can complicate the optimization of drug dosing for populations of patients. The combination of patient characteristics, disease…

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The Basel Phenotyping Capsule as a tool for Quantifying Human metabolism in vivo – a tool to personalize physiological and semiphysiological Models

Thursday 16 October, 2025

Objectives: Cytochrome P450 (CYP) enzymes are the main metabolic pathway of numerous endogenous and xenobiotic compounds. Hence, estimates of CYP…

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Absorption, Bioavailability, and Immunogenicity after Subcutaneous Administration: Evaluation of a Subcutaneous Platform within the Open Systems Pharmacology framework

Thursday 16 October, 2025

Introduction: Subcutaneous (SC) injection is a common route of drug administration for both small molecules and biologics. To support the…

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User-friendly and Quality-Controlled PBPK/QSP M&S Framework in R for Regulatory Submissions using Open Systems Pharmacology Software

Thursday 16 October, 2025

Objectives:  The increasing importance of Physiologically-Based Pharmacokinetic (PBPK) and Quantitative Systems Pharmacology (QSP) models for regulatory submissions in drug development…

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Uncovering Bias in Exposure-Response Relationships: Investigating the Impact of Exposure Calculation for Irregular Dosing Regimens

Thursday 16 October, 2025

Objectives:  The exploration of the relationship between drug exposure and clinical efficacy and safety response endpoints is vital for informed…

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Pharmacometric drug adherence approach and its application in a clinical setting

Thursday 16 October, 2025

Introduction: Adherence to medication is crucial for expected treatment outcomes. Poor adherence can result in sub-optimal drug exposure, thereby increasing…

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Inhibition of bile acids synthesis via fibroblast growth factor 19 (FGF19) through intestinal signaling: A population analysis

Thursday 16 October, 2025

Objectives: Regulation of bile acid (BA) synthesis is mediated through the farnesoid X receptor (FXR), which is predominantly expressed in…

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