Introduction Artificial intelligence and machine learning (AI/ML) approaches are increasingly being applied across pharmacometrics, including QSP, PBPK and population PK/PD….
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Physiologically Based Pharmacokinetic Modeling to Evaluate Drug–Herbal Interactions Between Conventional GERD Therapies and Banhasasim-tang
Objectives: Gastroesophageal reflux disease (GERD) is highly prevalent and frequently managed with both conventional pharmacotherapy and herbal formulations, highlighting the…
Read moreSafety Analysis of SAB-142, a Fully Human Anti-Thymocyte Globulin, Demonstrates Immunomodulatory Effects on Lymphocytes
Objectives Rabbit and horse-derived anti-thymocyte globulin (rATG or hoATG) are established drugs for immunosuppression that are administered following organ transplantation….
Read moreLinezolid Pharmacokinetics in Adults with Rifampicin-Resistant TB: Impact of Pregnancy and Lactation
Objectives Rifampicin-resistant tuberculosis (RR-TB) is a global health concern, with approximately 400 000 incident cases annually1. Linezolid is part of…
Read moreAutomated model selection for within-host viral dynamics of SARS-CoV-2 and IAV
Introduction: Within-host models are widely used to characterize viral kinetics, quantify host-pathogen interactions and to support the evaluation of antiviral…
Read moreMODEL-BASED META-ANALYSIS POPULATION PK MODELING OF ANTI-IL-5(RΑ) MONOCLONAL ANTIBODIES TO OPTIMIZE PEDIATRIC STUDY DESIGN USING STOCHASTIC SIMULATION-ESTIMATION
Objectives Several monoclonal antibodies (mAbs) are currently licensed for the treatment of severe eosinophilic asthma. Reslizumab and mepolizumab target IL-5,…
Read moreQUANTITATIVE SYSTEMS PHARMACOLOGY (QSP) MODELING OF EFFICACY AND NAUSEA OF GLP-1 RECEPTOR AGONIST (RA) SEMAGLUTIDE AND DUAL GLP-1/GIPRA TIRZEPATIDE IN NON-DIABETIC OBESE PATIENTS
Introduction & objectives: Glucagon-like-peptide-1 (GLP-1) and Glucose-dependent Insulinotropic Peptide (GIP) are peptides secreted primarily by intestinal mucosal cells in response…
Read moreMODEL-BASED META-ANALYSIS OF PARACETAMOL DOSE–RESPONSE IN PAEDIATRIC TONSILLECTOMY PAIN
Objectives: Model-Based Meta-Analysis (MBMA) is a quantitative method that combines aggregated data from multiple randomised clinical trials (RCTs) to improve…
Read morePopulation pharmacokinetics of intravenous Ceftazidime in critically ill paediatric patients
Introduction : Ceftazidime is a widely used antibiotic in the treatment of severe infections and cystic fibrosis (CF) in critically…
Read moreModel-Informed Biosimilar Study Design Under Evolving Regulatory Guidance: Dose Selection and Power Optimization in Pegfilgrastim
INTRODUCTION The FDA’s October 2025 draft update to Scientific Considerations in Demonstrating Biosimilarity marks a significant evolution in biosimilar development….
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