Sebastian Polak – Certara

Multi-phase Multi-layer Mechanistic Physiologically-based Pharmacokinetic Dermal Absorption Model Verification Including Inter- and Intra-individual Variability Assessment Using Nicotine as a Model Drug

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Predicting Depth Resolved Concentrations in the Dermis Using PBPK Modeling: Design, Development and Verification of the Model with Five Drugs

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Combining Machine Learning and Mechanistic Modeling Approaches to Solve Real Life Problems and Assessment of the Local Tissue Binding and Its Influence on the Systemic Exposure after Topical Application of Drugs

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Performance Verification of Mechanistic Dermal Physiological Based Pharmacokinetic (PBPK) Model for Enhanced Understanding of Dermal Absorption: Prediction of Local Tissue Exposure after Topical Application of Acitretin

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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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Authors: Sebastian Polak

Multi-phase Multi-layer Mechanistic Physiologically-based Pharmacokinetic Dermal Absorption Model Verification Including Inter- and Intra-individual Variability Assessment Using Nicotine as a Model Drug

Predicting Depth Resolved Concentrations in the Dermis Using PBPK Modeling: Design, Development and Verification of the Model with Five Drugs

Combining Machine Learning and Mechanistic Modeling Approaches to Solve Real Life Problems and Assessment of the Local Tissue Binding and Its Influence on the Systemic Exposure after Topical Application of Drugs

Performance Verification of Mechanistic Dermal Physiological Based Pharmacokinetic (PBPK) Model for Enhanced Understanding of Dermal Absorption: Prediction of Local Tissue Exposure after Topical Application of Acitretin

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Comparison of Proarrhythymia Classification Models