Scientific and regulatory evaluation of mechanistic in silico drug and disease models in drug development: Building model credibility

Reproducibility in systems biology modelling

(2021) Krishna Tiwari et al.   Molecular Systems Biology

In silico trials: Verification, validation and uncertainty quantification of predictive models used in the regulatory evaluation of biomedical products

(2020) Marco Viceconti et al.   METHODS

Blinded In Silico Drug Trial Reveals the Minimum Set of Ion Channels for Torsades de Pointes Risk Assessment

(2020) Xin Zhou et al.   Frontiers in Pharmacology

The Potential of Computational Modeling to Predict Disease Course and Treatment Response in Patients with Relapsing Multiple Sclerosis

(2020) Francesco Pappalardo et al.   Cells

Credible practice of modeling and simulation in healthcare: ten rules from a multidisciplinary perspective

(2020) Ahmet Erdemir et al.   Journal of Translational Medicine

Generation of digital patients for the simulation of tuberculosis with UISS-TB

(2020) Miguel A. Juárez et al.   BMC BIOINFORMATICS

Moving forward through the in silico modeling of tuberculosis: a further step with UISS-TB

(2020) Giulia Russo et al.   BMC BIOINFORMATICS

Model-Informed Drug Development: Current U.S. Regulatory Practice and Future Considerations

(2019) Yaning Wang et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

The US Food and Drug Administration's Model‐Informed Drug Development Paired Meeting Pilot Program: Early Experience and Impact

(2019) Rajanikanth Madabushi et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Drug‐induced Shortening of the Electromechanical Window is an Effective Biomarker for in Silico Prediction of Clinical Risk of Arrhythmias

(2019) Elisa Passini et al.   BRITISH JOURNAL OF PHARMACOLOGY

Human in silico trials on drug-induced changes in electrophysiology and calcium dynamics using the virtual assay software

(2019) Elisa Passini et al.   JOURNAL OF PHARMACOLOGICAL AND TOXICOLOGICAL METHODS

Predicting the artificial immunity induced by RUTI® vaccine against tuberculosis using universal immune system simulator (UISS)

(2019) Marzio Pennisi et al.   BMC BIOINFORMATICS

Credibility of In Silico Trial Technologies—A Theoretical Framing

(2019) Marco Viceconti et al.   IEEE Journal of Biomedical and Health Informatics

Systems Biology, Systems Medicine, Systems Pharmacology: The What and The Why

(2018) Angélique Stéphanou et al.   ACTA BIOTHEORETICA

In silico clinical trials: concepts and early adoptions

(2018) Francesco Pappalardo et al.   BRIEFINGS IN BIOINFORMATICS

Computational modeling reveals MAP3K8 as mediator of resistance to vemurafenib in thyroid cancer stem cells

(2018) Fiorenza Gianì et al.   BIOINFORMATICS

Multiscale modeling methods in biomechanics

(2017) Pinaki Bhattacharya et al.   Wiley Interdisciplinary Reviews-Systems Biology and Medicine

Human In Silico Drug Trials Demonstrate Higher Accuracy than Animal Models in Predicting Clinical Pro-Arrhythmic Cardiotoxicity

(2017) Elisa Passini et al.   Frontiers in Physiology

A computational model to predict the immune system activation by citrus-derived vaccine adjuvants

(2016) Francesco Pappalardo et al.   BIOINFORMATICS

Physiologically based pharmacokinetic modeling in regulatory decision-making at the European Medicines Agency

(2016) E Luzon et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

The promises of quantitative systems pharmacology modelling for drug development

(2016) V.R. Knight-Schrijver et al.   Computational and Structural Biotechnology Journal

Computational modeling of the expansion of human cord blood CD133+hematopoietic stem/progenitor cells with different cytokine combinations

(2015) Francesca Gullo et al.   BIOINFORMATICS

Verification Benchmarks to Assess the Implementation of Computational Fluid Dynamics Based Hemolysis Prediction Models

(2015) Prasanna Hariharan et al.   JOURNAL OF BIOMECHANICAL ENGINEERING-TRANSACTIONS OF THE ASME

What Happened to the Modeling and Simulation Revolution?

(2014) P L Bonate   CLINICAL PHARMACOLOGY & THERAPEUTICS

Regenerative orthopaedics: in vitro, in vivo … in silico

(2014) Liesbet Geris   INTERNATIONAL ORTHOPAEDICS

Best Practice in the Use of Physiologically Based Pharmacokinetic Modeling and Simulation to Address Clinical Pharmacology Regulatory Questions

(2012) P Zhao et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

In silico Modeling and In vivo Efficacy of Cancer-Preventive Vaccinations

(2010) A. Palladini et al.   CANCER RESEARCH

Structural and practical identifiability analysis of partially observed dynamical models by exploiting the profile likelihood

(2009) A. Raue et al.   BIOINFORMATICS

A pharmacologically based multiscale mathematical model of angiogenesis and its use in investigating the efficacy of a new cancer treatment strategy

(2009) Frédérique Billy et al.   JOURNAL OF THEORETICAL BIOLOGY

Systems biology and the virtual physiological human

(2009) Peter Kohl et al.   Molecular Systems Biology

Pharmacometrics: A Multidisciplinary Field to Facilitate Critical Thinking in Drug Development and Translational Research Settings

(2008) Jeffrey S. Barrett et al.   JOURNAL OF CLINICAL PHARMACOLOGY

Development of good modelling practice for physiologically based pharmacokinetic models for use in risk assessment: The first steps

(2008) George Loizou et al.   REGULATORY TOXICOLOGY AND PHARMACOLOGY