Objectives: The COMBINE consortium has developed a standardized murine pneumonia model to harmonize preclinical efficacy data and improve translational relevance…
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LEVERAGING SEMI-MECHANISTIC PHARMACOKINETIC MODELING TO ESTABLISH CLINICALLY RELEVANT DISSOLUTION SAFE SPACES IN COMPASS SOFTWARE
Introduction: The so-called dissolution safe space defines the specific boundaries of in vitro dissolution specifications within which different batches of…
Read moreCVAE–LASSO: INTEGRATED L1-REGULARIZED COVARIATE SELECTION WITHIN A CONDITIONAL LATENT FRAMEWORK FOR POPULATION PHARMACOKINETIC MODELLING
Objectives: Population pharmacokinetic (PopPK) modelling is central to quantify inter-individual variability and identify covariates driving drug exposure, supporting individualized dosing…
Read moreHybrid AI-PBPK Framework for End-to-End Pharmacokinetic Prediction from SMILES
Objectives: Drug development requires scalable and traceable pharmacokinetic (PK) prediction frameworks that support compound prioritization and model-informed translation across development…
Read moreGENOME WIDE ASSOCIATION STUDY OF MODEL-DERIVED TIME TO VIRAL CLEARANCE IN COVID-19: COMPARISON OF METHODS IN A SIMULATION STUDY AND APPLICATION TO THE DISCOVERY TRIALS.
Objectives : COVID-19 severity varies widely across individuals, from asymptomatic infection to life threatening illness [1]. Demographic and clinical factors…
Read morePopulation pharmacokinetic modelling of plasma and target-site metronidazole: Reduced target-site exposure suggests underdosing in obese patients
Introduction: To prevent surgical site infections (SSI) caused by anaerobic bacteria, thus optimising perioperative care, a flat dose of 500…
Read moreA PRECLINICAL PK/PD MODEL OF PYRONARIDINE IN SCID MICE: A TRANSLATIONAL WORKFLOW FOR PREDICTING ANTIMALARIAL EFFICACY IN HUMANS
Background: Pyronaridine is a long-acting antimalarial agent that binds to hematin, preventing hemozoin formation and leading to parasite death. It…
Read morePost-hoc model joining with Normalizing Flows for efficient and scalable multi-endpoint PKPD
Objectives Utilizing longitudinal biomarkers to improve primary endpoint predictions is a common objective in clinical pharmacology, yet traditional joint NLME…
Read moreIntegrin α4β7 pathway in the QSP model of IBD describes vedolizumab efficacy
Objectives: Current understanding of pathogenesis and treatment of inflammatory bowel disease (IBD) remains incomplete, because the disease progression is controlled…
Read moreMONTE CARLO EXPECTATION-MAXIMIZATION IN PUMAS: LEVERAGING SUFFICIENT STATISTICS FOR FLEXIBLE PHARMACOMETRIC ANALYSIS
Introduction: Expectation-maximization (EM) algorithms are a well-established alternative to likelihood-approximation-based methods such as FOCE and the Laplace method for parameter…
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