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

M Viceconti, F Pappalardo, B Rodriguez, M Horner… - Methods, 2021 - Elsevier
Historically, the evidences of safety and efficacy that companies provide to regulatory
agencies as support to the request for marketing authorization of a new medical product …

Credibility of In Silico Trial Technologies—A Theoretical Framing

M Viceconti, MA Juárez, C Curreli… - IEEE journal of …, 2019 - ieeexplore.ieee.org
Different research communities have developed various approaches to assess the credibility
of predictive models. Each approach usually works well for a specific type of model, and …

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

FT Musuamba, I Skottheim Rusten… - CPT …, 2021 - Wiley Online Library
The value of in silico methods in drug development and evaluation has been demonstrated
repeatedly and convincingly. While their benefits are now unanimously recognized …

[HTML][HTML] In silico toxicology protocols

GJ Myatt, E Ahlberg, Y Akahori, D Allen… - Regulatory Toxicology …, 2018 - Elsevier
The present publication surveys several applications of in silico (ie, computational)
toxicology approaches across different industries and institutions. It highlights the need to …

In silico methods to predict drug toxicity

A Roncaglioni, AA Toropov, AP Toropova… - Current opinion in …, 2013 - Elsevier
Highlights•In silico models facilitate the expert to evaluate toxicity, analyzing results of a
battery of models.•In silico models can address among others, the presence of structural …

In silico clinical trials: how computer simulation will transform the biomedical industry

M Viceconti, A Henney… - International Journal of …, 2016 - eprints.whiterose.ac.uk
The term 'in silico clinical trials indicates the use of individualised computer simulation in the
development or regulatory evaluation of a medicinal product, medical device, or medical …

In silico clinical trials: concepts and early adoptions

F Pappalardo, G Russo, FM Tshinanu… - Briefings in …, 2019 - academic.oup.com
Innovations in information and communication technology infuse all branches of science,
including life sciences. Nevertheless, healthcare is historically slow in adopting …

The challenges involved in modeling toxicity data in silico: a review

MP Gleeson, S Modi, A Bender… - Current …, 2012 - ingentaconnect.com
The percentage of failures in late pharmaceutical development due to toxicity has increased
dramatically over the last decade or so, resulting in increased demand for new methods to …

Predicting human safety: screening and computational approaches

DE Johnson, GHI Wolfgang - Drug discovery today, 2000 - Elsevier
Current preclinical safety evaluation programs use a combination of computational methods,
mechanistic in vitro screening and–primarily–in vivo experimentation to predict human …

[HTML][HTML] In silico pharmacology: computer-aided methods could transform drug development

C Shekhar - Chemistry & biology, 2008 - cell.com
With the rapidly growing and aging world population comes an urgent and rising demand for
new and better drugs. Many observers feel that the pharmaceutical industry seems unable to …