Sebastian Polak – Certara

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Real Patients & Their Virtual Twins: A New Paradigm for Personalized Drug Safety Assessment

In this webinar, Sebastian Polak, Nikunj Patel, and Mark Holbrook introduced the Cardiac Safety Simulator (CSS) platform and explained how they developed a QSTS model for citalopram to serve as a “virtual twin” and help predict the likely occurrence of cardiotoxic events in real patients under different clinical conditions.

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Quantitative Prediction of Dermal Drug Absorption Using MPML-MechDermA Model: Relative Effects of Application Site on Rivastigmine Pharmacokinetics from a Transdermal Delivery System

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Development and Verification of PBPK Model for a Topical Cream Formulation of Trifarotene to Simulate Local and Systemic Exposure and Model Application to Simulate Potential CYP-mediated Drug-drug Interactions

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Development and Validation of a Dermal PBPK Model for Prediction of the Hair Follicular Absorption of Caffeine: Application of the Simcyp MechDermA Model

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In Silico Assessment of Nifedipine Effects on Human Heart Cells: Pharmacokinetic-pharmacodynamic Analyses at the Population Level

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Multi-phase Multi-layer MechDermA Model: Development, Verification and Application of a PBPK-PD Model of Dermal Absorption for Transdermal Product Assessment

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Multi-phase Multi-layer MechDermA Model: Development, Verification and Application of a PBPK/PD Model of Dermal Absorption for Transdermal Product Assessment

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Development and Validation of a Dermal PBPK Model for Prediction of the Hair Follicular Absorption of Caffeine: Application of the Simcyp MPML MechDermA Model

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Simulation of Pharmacokinetics of Amitriptyline and Nortriptyline and Their Common Effect on Human Cardiac Electrophysiology in Healthy Population

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Physiologically-based Pharmacokinetic Model (PBPK) for the Halofantrine Cardiac Effect Prediction – Proof of Concept Study towards the System for the Antimalarial Drugs Cardiac Safety Assessment

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Predicting Diclofenac Systemic and Synovial Fluid Concentrations After Dermal Application Using the Multi-phase Multi-layer MechDermA PBPK Model

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Commentary on “In Silico Modeling of Gastrointestinal Drug Absorption: Predictive Performance of Three Physiologically-based Absorption Models”

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Early Assessment of Proarrhythmic Risk of Drugs Using the In Vitro Data and Single-cell-based In Silico Models: Proof of Concept

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Development and Validation of Dermal PBPK Model Towards Virtual Bioequivalence Assessment: Prediction of Dermal Drug Absorption of Various Ibuprofen Formulations Using Simcyp MechDermA Model

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Quantitative Assessment of the Physiological Parameters Influencing QT Interval Response to Medication—Simulation Study

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Comparison of Proarrhythymia Classification Models

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In Silico Assessment of Antiarrhythmic Effects of Drug Ranolazine on Electrical Activity in Human Ventricular Myocardium

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Towards Development and Validation of the Dermal PBPK Model for Virtual Bioequivalence—Model Description and Validation Case Studies

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Drug-drug Interactions and QT Prolongation as a Commonly Assessed Cardiac Effect—Comprehensive Overview of Clinical Trials

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Quantitative Approach for Cardiac Risk Assessment and Interpretation in Tuberculosis Drug Development

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