PBPK Modeling & Simulation

How to Demonstrate Virtual Bioequivalence for Complex Dermal Generic Drugs

This webinar will explain how Certara expanded its PBPK Simcyp Simulator to incorporate an extensive dermal model— MPML MechDermA, a multi-phase, multi-dimensional dermal absorption model.

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LEO Pharma Joins Certara’s PBPK Simcyp Simulator Consortium

PRINCETON, NJ – Dec. 10, 2019 – LEO Pharma has licensed Certara’s proprietary Simcyp®️ Population-based Simulator and joined its Consortium.

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What’s New in the Simcyp Simulator v19?

This webinar explained how the latest updates in the Simcyp Simulator v19, Certara’s physiologically-based pharmacokinetic (PBPK) modeling and simulation platform, will support developing safer, more effective medications faster.

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Predicting Human Oral Bioavailability: Comparison of In Vivo Animal (Rat- Dog- and Monkey) Studies versus Mechanistic In Vitro In Vivo Extrapolation (IVIVE) Based Predictions

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Fitting PBPK Model Parameters within Simcyp Engine Using Simcyp-R Package

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Development of a PBPK model for the prediction of Amiodarone pharmacokinetics in fed and fasted state using the Advanced Dissolution, Absorption and Metabolism (ADAM) model

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Development of a Permeability-Limited Cardiac Physiologically-Based Pharmacokinetic Model for Predicting Cardiac Exposure

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Dosing corrected for species differences in toxicokinetics using PBPK modelling predicts equivalent reactive metabolite burden following acetaminophen overdose

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Predicting Human Oral Bioavailability: Comparison of in vivo animal (rat, dog, and monkey) studies versus mechanistic in vitro in vivo extrapolation (IVIVE) based predictions

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Predictive Performance of Caffeine Preterm PBPK Model and Effect of Time-Varying Physiology on Predictions

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Prediction of Drug-Drug Interaction between Phenobarbital and Theophylline in Children using Physiologically-Based Pharmacokinetic Modelling

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Development of a PBPK model for the prediction of Amiodarone pharmacokinetics in fed and fasted state using ADAM model

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The Certara Quantitative Systems Toxicology & Safety (QSTS) Pharma Consortium: Overview and Invitation to Join

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Quantitative Systems Toxicology Approach Integrates Simcyp PBPK and Core Hepatocyte Metabolism: a Case Study with Valproic Acid

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Prediction of mAb disposition in hepatic impairment – Evolocumab as a case study

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Use of a physiologically based pharmacokinetic – pharmacodynamic (PBPK-PD) model to guide dose adjustments to S-warfarin in different populations

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Biopharmaceutic In Vitro In Vivo Extrapolation (IVIV_E) Informed PBPK Model of Ritonavir Norvir® Tablet Absorption in Humans Under Fasted and Fed State Conditions

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Accounting for CYP2C19 mechanism based inhibition and CYP1A2 induction in a PBPK model for omeprazole

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Physiological verification of a geriatric population using the Simcyp R package

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Estimation of Effective pKa of Bicarbonate Buffer

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Solution: PBPK Modeling & Simulation

How to Demonstrate Virtual Bioequivalence for Complex Dermal Generic Drugs

LEO Pharma Joins Certara’s PBPK Simcyp Simulator Consortium

What’s New in the Simcyp Simulator v19?

Predicting Human Oral Bioavailability: Comparison of In Vivo Animal (Rat- Dog- and Monkey) Studies versus Mechanistic In Vitro In Vivo Extrapolation (IVIVE) Based Predictions

Fitting PBPK Model Parameters within Simcyp Engine Using Simcyp-R Package

Development of a PBPK model for the prediction of Amiodarone pharmacokinetics in fed and fasted state using the Advanced Dissolution, Absorption and Metabolism (ADAM) model

Development of a Permeability-Limited Cardiac Physiologically-Based Pharmacokinetic Model for Predicting Cardiac Exposure

Dosing corrected for species differences in toxicokinetics using PBPK modelling predicts equivalent reactive metabolite burden following acetaminophen overdose

Predicting Human Oral Bioavailability: Comparison of in vivo animal (rat, dog, and monkey) studies versus mechanistic in vitro in vivo extrapolation (IVIVE) based predictions

Predictive Performance of Caffeine Preterm PBPK Model and Effect of Time-Varying Physiology on Predictions

Prediction of Drug-Drug Interaction between Phenobarbital and Theophylline in Children using Physiologically-Based Pharmacokinetic Modelling

Development of a PBPK model for the prediction of Amiodarone pharmacokinetics in fed and fasted state using ADAM model

The Certara Quantitative Systems Toxicology & Safety (QSTS) Pharma Consortium: Overview and Invitation to Join

Quantitative Systems Toxicology Approach Integrates Simcyp PBPK and Core Hepatocyte Metabolism: a Case Study with Valproic Acid

Prediction of mAb disposition in hepatic impairment – Evolocumab as a case study

Use of a physiologically based pharmacokinetic – pharmacodynamic (PBPK-PD) model to guide dose adjustments to S-warfarin in different populations

Biopharmaceutic In Vitro In Vivo Extrapolation (IVIV_E) Informed PBPK Model of Ritonavir Norvir® Tablet Absorption in Humans Under Fasted and Fed State Conditions

Accounting for CYP2C19 mechanism based inhibition and CYP1A2 induction in a PBPK model for omeprazole

Physiological verification of a geriatric population using the Simcyp R package

Estimation of Effective pKa of Bicarbonate Buffer