Thursday 7 May, 2026
Background: Precision dosing refers to tailoring drug doses to individual patient characteristics to maximize the efficacy-safety balance [1]. Adaptive dosing…
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A PREDICTIVE MODELING FRAMEWORK TO RECONSTRUCT AND SIMULATE PFS
Thursday 7 May, 2026
Background: In advanced breast cancer, progression-free survival (PFS) is a primary registrational endpoint and a critical metric for early development…
Read moreAssessing Cross-Version Simcyp Simulator Prediction Performance Using a Bioequivalence Framework to Support EMA Qualification
Thursday 7 May, 2026
Introduction: The Simcyp Simulator V19 was qualified for predicting drug-drug interactions for 6 CYP enzymes (CYP1A2, CYP2C8, CYP2C9, CYP2C19, CYP2D6,…
Read morePopPK and PKPD Modeling of Oral NLRP3 Inhibitor Supporting Dose Simulation in Parkinson’s Disease
Thursday 7 May, 2026
Objectives: The release of pro-inflammatory cytokines, including interleukin (IL)-18 and IL-1β, is potentially driven by the Nucleotide-binding oligomerization domain, leucine-rich…
Read morePHYSIOLOGICALLY BASED PHARMACOKINETIC MODEL FOR PREDICTING FOOD EFFECT ON THE PHARMACOKINETICS OF RADOTINIB
Thursday 7 May, 2026
Objectives: Radotinib, a weakly basic and lipophilic second-generation tyrosine kinase inhibitor, was approved for the treatment of chronic myeloid leukemia…
Read moreComparing Cystatin-C with Serum Creatinine for Predicting Vancomycin Clearance in Critically ill pediatric Patients: A Population Pharmacokinetic Study
Thursday 7 May, 2026
Objective: This study aimed to determine whether serum creatinine (SCr), cystatin C (CysC), or combined biomarker–based equations provide the most…
Read moreAccelerating Gold Standard Evolution in Pharmacometrics: A Framework for Cross-Study Benchmarking of Covariate Modeling Methods
Thursday 7 May, 2026
Objectives For the past few years, pharma industries have been working to shorten development timelines. In 2026, Sanofi aims at…
Read moreTHE TOP-DOWN PBFTPK MODELS VIS A VIS THE BOTTOM-UP PBPK MODELS IN EARLY DRUG DEVELOPMENT
Thursday 7 May, 2026
Introduction: The introduction of Finite Absorption Time (F.A.T.) [1,2] concept led to the development of Physiologically Based Finite Time Pharmacokinetic…
Read moreCYTOCON AND FIVEDB: FREELY ACCESSIBLE DATABASES FOR STREAMLINING QSP MODEL CALIBRATION AND VALIDATION
Thursday 7 May, 2026
Objectives: Quantitative Systems Pharmacology (QSP) model development requires extensive data for calibration and validation, yet sourcing these data from literature…
Read morePRECURSOR-POOL MODEL OF CYTOKINE KINETICS IN PATIENTS RECEIVING LINVOSELTAMAB
Thursday 7 May, 2026
Introduction: Cytokine release syndrome (CRS) is a systemic inflammatory response triggered by several factors such as infections and certain drugs,…
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