Sebastian Polak – Certara

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

Proarrhythmia assessment is one of the major concerns for regulatory bodies and pharmaceutical industry. ICH guidelines recommending preclinical tests have been established in attempt to eliminate the risk of drug-induced arrhythmias. However, in the clinic, arrhythmia occurrence is determined not only by the inherent property of a drug to block ion currents and disturb electrophysiological […]

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Towards mechanistic simulation and prediction of bioequivalence studies of topical formulations case study with two diclofenac formulations

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Simulating Cardiac Consequences of the Genetic Variability at the Metabolism Level With Use of Middle-Out Approach and Flecainide as an Example Compound

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Pharmacokinetic (PK) and Pharmacodynamic (PD) Implications of Diurnal Variation of Gastric Emptying and Small Intestinal Transit Time for Quinidine Mechanistic Simulation

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Prediction of the In Vivo Behaviour of Modified Release Formulations of Metoprolol from In Vitro Dissolution Profiles Using the ADAM Model (Simcyp^® V8)

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Impact of Variability in Estimates of Drug Diffusion Coefficient on the Prediction of Fraction Absorbed from the Gut (fa) Using the ADAM Model (Simcyp v7.1)

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Mechanistic modeling of dermal drug absorption using the Simcyp Multi-phase Multi-layer MechDermA model: Case study of a transdermal patch formulation of weak base drug timolol

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Quantitative Prediction of Circadian Variation Impacts on Pharmacokinetics (PK): Dependence on Route of Administration in the Case of BCS/BDDCS Class II and CYP3A4 Substrate Drug Nifedipine

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Mechanistic Models of Human Pharmacokinetics to Predict the Effects of Liver Cirrhosis on the Clearance of Nine Drugs

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Mechanistic Models of Human Pharmacokinetics to Predict the Effects of Liver Cirrhosis on the Clearance of Nine Drugs

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Population level simulation of the action potential as a system for the drugs pro-arrhythmic potency classification

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Simulating pharmacokinetic and pharmacodynamic impact of the drug formulation on the human cardiac safety by applying in vitro – in vivo extrapolation approach

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Prediction of skin disposition after topical application of drugs Simcyp platform as a tool for capturing system information and safety assessment

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Combining In Vitro-In Vivo Extrapolation (IVIVE) and Physiologically-based Pharmacokinetics (PBPK) with Drug Related Risk Assessment: Putting Pieces Together for A Priori Assessment of the Likelihood of Cardiotoxicity

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Prediction of Human Pharmacokinetics Following Dermal Administration: Integration of a Skin Absorption Module to the Simcyp^® Population-based ADME Simulator with the Aim of Avoiding Animal Studies

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Importance of formulation type, ionization at skin surface, binding to keratin along with thickness and lipid levels of skin layers in quantitative prediction of human dermal absorption of diclofenac and ibuprofen

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Conventional versus Physiologically-based (PB)-IVIVC: Revisiting some successful and failed conventional IVIVC cases with PB-IVIVC

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Quantitative prediction of human dermal absorption from in vitro/in silico data using Simcyp Simulator – Importance of ionization at skin surface and binding to keratin along with the thickness and lipid levels of skin layers

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Prediction of QT changes in humans incorporating in vitro data into physiologically-based cardiomyocyte cell model – a case study on inhibition of multiple cardiac ion currents by tolterodine and its metabolite

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Mechanistic Deconvolution Using the ADAM Model: Part 2. Designing a New Once Daily Formulation for Metoprolol Based on Mechanistic IVIVC and Studying the Population Variability in its Pharmacokinetics

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