Objectives: In R, dynamic linked models (DLL’s) have been proved to increase the speed of repetitive tasks, such as clinical…
Read morePoster: Methodology - Other topics
A technical concept of automatic PBPK platform (re-)qualification in the Open Systems Pharmacology Suite (PK-Sim® and MoBi®)
Objectives: The recently issued draft guideline on physiologically-based pharmacokinetic modeling (PBPK) by the European Medicines Agency (EMA) [1] demands the…
Read moreA comparison of two model reduction methodologies for a QSP bone biology system with denosumab dosing.
Introduction:The increasing use of quantitative systems pharmacology (QSP) and physiologically-based pharmacokinetic (PBPK) modelling in drug development has caused modellers to…
Read moreConsiderations for the application of PBPK to optimize drug therapies in special populations: The Open Systems Pharmacology solutions
Objectives: Multiple factors can complicate the optimization of drug dosing for populations of patients. The combination of patient characteristics, disease…
Read moreThe Basel Phenotyping Capsule as a tool for Quantifying Human metabolism in vivo – a tool to personalize physiological and semiphysiological Models
Objectives: Cytochrome P450 (CYP) enzymes are the main metabolic pathway of numerous endogenous and xenobiotic compounds. Hence, estimates of CYP…
Read moreAbsorption, Bioavailability, and Immunogenicity after Subcutaneous Administration: Evaluation of a Subcutaneous Platform within the Open Systems Pharmacology framework
Introduction: Subcutaneous (SC) injection is a common route of drug administration for both small molecules and biologics. To support the…
Read moreUser-friendly and Quality-Controlled PBPK/QSP M&S Framework in R for Regulatory Submissions using Open Systems Pharmacology Software
Objectives: The increasing importance of Physiologically-Based Pharmacokinetic (PBPK) and Quantitative Systems Pharmacology (QSP) models for regulatory submissions in drug development…
Read moreUncovering Bias in Exposure-Response Relationships: Investigating the Impact of Exposure Calculation for Irregular Dosing Regimens
Objectives: The exploration of the relationship between drug exposure and clinical efficacy and safety response endpoints is vital for informed…
Read morePharmacometric drug adherence approach and its application in a clinical setting
Introduction: Adherence to medication is crucial for expected treatment outcomes. Poor adherence can result in sub-optimal drug exposure, thereby increasing…
Read moreInhibition of bile acids synthesis via fibroblast growth factor 19 (FGF19) through intestinal signaling: A population analysis
Objectives: Regulation of bile acid (BA) synthesis is mediated through the farnesoid X receptor (FXR), which is predominantly expressed in…
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