Thursday 7 May, 2026
Title: Model-Informed Drug Development at Sِaudi FDA: Approaches, Applications, and Regulatory Impact Author: Alanood Alkhaldi (1), Jamilah Alnahdi(1), Abdullah Alsultan(2),…
Read morePoster: Methodology - Other topics
Use the AUC and discard Cmax in exposure-response analysis
Thursday 7 May, 2026
Introduction Exposure-response (ER) analyses of repeatedly administered drugs often rely on the use of an exposure metric at steady-state: the…
Read moreImpact of Below Limit of Quantification (BLQ) Concentrations handling strategies on Concentration-QTc analysis
Thursday 7 May, 2026
Introduction: The International Council for Harmonisation (ICH) guideline allows for modeling of concentration-QTc (C-QTc) data from Phase I dose-escalation studies…
Read moremonolixSuiteTFL: AN R PACKAGE FOR AUTOMATED TABLES, FIGURES AND LISTINGS FROM MONOLIXSUITE PROJECTS
Thursday 7 May, 2026
INTRODUCTION Clinical reporting of Tables, Figures and Listings (TFLs) is often time-consuming and error-prone due to repetitive post-processing and formatting…
Read morePOPULATION PHARMACOKINETIC MODELLING TO SUPPORT BIOEQUIVALENCE ASSESSMENT OF GENERIC DRUGS: AN ILLUSTRATIVE SIMULATION STUDY USING AMODIAQUINE.
Thursday 7 May, 2026
Objectives: Bioequivalence (BE) of generic drugs is traditionally assessed using non-compartmental analysis (NCA) of exposure metrics such as AUC and…
Read moreEnhancing Data Sharing and Anonymization to Enable Model-Based Approaches and Virtual Patient Cohorts in the INVENTS Project
Thursday 7 May, 2026
Objectives: Drug development in rare diseases and paediatrics is challenging due to limited disease understanding, small sample sizes, single-arm trials…
Read moreUsage and regulatory acceptance of PBPK models in paediatric drug applications:a review of EMA and FDA public assessment reports
Thursday 7 May, 2026
Introduction: The recent decade has seen considerable growth of paediatric physiologically-based pharmacokinetic (PBPK) applications both in academia and industry, however,…
Read moreBridging insights: Quantitative pharmacology-biostatics collaboration of Population PKPD and Bayesian Logistic Regression Enabling Dosage Selection in Early-Phase Oncology
Thursday 7 May, 2026
Objective: Traditional oncology dose-finding trials primarily focus on dose-limiting toxicity (DLT) data to guide dose-escalation decisions. Bayesian Logistic Regression Models…
Read moreSTREAMLINED OPEN-SOURCE PBPK DDI ASSESSMENTS USING THE OSP SUITE WITH R-BASED esqlabsR/ESQapp WORKFLOWS
Thursday 7 May, 2026
Objectives: Drug-drug interactions (DDIs) are a major concern in drug development and clinical practice. Mechanistic physiologically based pharmacokinetic (PBPK) modeling…
Read moreCOMPARISON OF MASPECTRA AND NONMEM FOR POPULATION PHARMACOKINETIC MODELING: AN ABSK-011 (IRPAGRATINIB) CASE STUDY
Thursday 7 May, 2026
Note: H. Zheng and C. Wang contributed equally to this research. Introduction: Maspectra [1] is a software platform for modeling…
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