Introduction Pharmacometrics analysis can be represented as workflow comprising multiple highly specialized steps that typically include data processing, data digitization,…
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InVitroInVivoCorrelation.jl: A MODULAR JULIA PACKAGE FOR LEVEL A IVIVC
Introduction: Establishing a robust in vitro-in vivo correlation (IVIVC) remains central to formulation development, clinically relevant dissolution specification setting, and…
Read moreReal-Time Interactive Visualization in Pharmacometrics: Leveraging Modern Dynamic Graphical Tools for Exploratory Analysis, Diagnostics, and Reporting
Objectives Pharmacokinetic/pharmacodynamic (PK/PD) modeling outputs, including goodness-of-fit (GOF) plots, visual predictive checks (VPCs), forest plots, and exposure–response analyses, are traditionally…
Read moreCOMPARISON OF METHODS TO DEMONSTRATE BIOEQUIVALENCE IN CASE OF HIGH VARIABILITY AND GROUP HETEROGENEITY
Introduction/Objectives: Bioequivalence (BE) studies are conducted to evaluate the similarity in pharmacokinetic (PK) profiles between two drugs or formulations [1,…
Read moreDose rationale for bedaquiline in paediatric patients with multi drug-resistant tuberculosis
Objectives: At the forefront of the causes of death globally, multi-drug resistant (MDR) tuberculosis (TB) manifests severely in children, posing…
Read moreEtravirine’s Pharmacokinetics Explored: PBPK Modeling and DDI Analysis with Efavirenz for Cancer Treatment
Objectives: Drug repurposing is an emerging strategy in the quest for new cancer therapies, offering distinct advantages such as leveraging…
Read moreSunburst Plots for Analyzing the Impact of Drugs on CRS
Objectives: Cytokine release syndrome (CRS) is caused by substantial, rapid release of cytokines into the circulation from immune cells, often…
Read moreDevelopment of a gestational Physiologically Based Kinetic model to predict rat dam and fetus exposure in PK-Sim/MoBi
Introduction/Objectives: The Open Systems Pharmacology (OSP) Suite, with its two mechanistic modeling and simulation software solutions PK-Sim® and MoBi®, as…
Read moreChoice of Exposure Metric in Exposure-Response Modeling
Introduction: Exposure-response (E-R) modeling plays an important role in model-informed drug development, especially in dose selection. A key step in…
Read moreBridging the gap between secondary pharmacology and hemodynamics findings via Quantitative Systems modelling
Objectives: Pharmaceutical companies routinely screen compounds in vitro and in vivo to understand hemodynamics related safety risks. Our current model…
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