Background: It is known that visual predictive checks (VPC) cannot be used reliably when real world data (RWD) or data…
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IMPROVING CLINICAL DATA HARMONIZATION FOR POPULATION APPROACHES USING GRAPH DATABASES
Introduction/Objectives. Population approaches typically rely on relational, tabular datasets as the core structure for storing and transforming clinical information prior…
Read moreCAN AN EXISTING PEDIATRIC PHYSIOLOGICALLY-BASED PREDICTED PHARMACOKINETIC (PBPK) MODEL FOR CEFEPIME BE USED FOR EXTRAPOLATION TO YOUNGER INFANTS?
Objectives: Physiologically based pharmacokinetic (PBPK) modelling is a tool increasingly used to support pediatric dosing decisions during drug development. In…
Read morePOPULATION PHARMACOKINETIC MODELLING OF BEDAQUILINE IN CENTRAL NERVOUS SYSTEM TISSUES IN A RABBIT MODEL OF TUBERCULOUS MENINGITIS
Objectives: Tuberculous meningitis (TBM) is the most severe form of tuberculosis (TB) and is associated with high mortality and long-term…
Read morePHYSIOLOGICALLY BASED PHARMACOKINETIC MODELING OF ELEXACAFTOR–TEZACAFTOR–IVACAFTOR DURING PREGNANCY WITH INTEGRATED EX VIVO HUMAN PLACENTAL TRANSFER DATA TO PREDICT MATERNAL AND FETAL EXPOSURE
Objectives: Pregnancies among women with cystic fibrosis (CF) have increased markedly in the era of highly effective CFTR modulators, particularly…
Read moreA NOVEL MATHEMATICAL FRAMEWORK TO PREDICT IN VIVO BISPECIFIC GTX-B001 BINDING IN SKIN AND TRANSLATION TO HUMANS
INTRODUCTION: GTX-B001 is a humanized bispecific antibody designed to selectively target and inhibit mast cells by binding to c-Kit and…
Read moreSIMULATION AND ESTIMATION OF CORRELATED NON-GAUSSIAN RANDOM EFFECTS IN PUMAS USING COPULAS
Objectives: Nonlinear mixed-effects models typically assume multivariate normal random effects to describe inter-individual variability. In some applications, more flexible marginal…
Read moreA quantitative systems pharmacology (QSP) model of neuroinflammation in Mild Cognitive Impairment and early Alzheimer’s Disease dementia
Objectives: Neuroinflammation plays a critical role in Alzheimer’s Disease (AD) pathogenesis, with multiple therapeutic targets being investigated in the clinic….
Read moreA population pharmacokinetics and exposure–response framework for tacrolimus dose optimization in intestinal transplantation
Objectives Tacrolimus is the cornerstone immunosuppressant after intestinal transplantation, a rare but life saving option for irreversible complicated intestinal failure….
Read moreKPD-ML PREDICTION OF DOCETAXEL‑INDUCED NEUTROPENIA IN LARGE RWE DATASETS
Introduction: Neutropenia remains a common and clinically important toxicity of cytotoxic chemotherapy, and early risk prediction is central to safer…
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