Annual Meeting of the Japanese Society of Toxicology
The 50th Annual Meeting of the Japanese Society of Toxicology
Session ID : S18-2
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Symposium 18: Current Application and Future Prospects of Data Science in Toxicology / Safety Evaluation
Quantitative Systems Pharmacology for Toxicology and Safety Assessment
*Ryuta SAITO
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CONFERENCE PROCEEDINGS FREE ACCESS

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Abstract

To improve R&D efficiency and facilitate scientific decision making in drug discovery and development by using mathematical model of pharmacology and toxicology, quantitative systems pharmacology (QSP) is increasingly being utilized in pharmaceuticals and biotech industries.

QSP approach has emerged as a central technology in innovative framework based on “learn and confirm” cycle, which is currently called as Model-informed Drug Discovery and Development (MID3) (CPT Pharmacometrics Syst Pharmacol. 2016; 5: 93-122.). QSP approach is supporting the rational decision in drug discovery and development from exploratory research to late-stage clinical development, and enables selection/validation of novel target molecules, identification of mechanism-of-action of pharmacological/toxicological compounds, prioritization of pharmaceutical candidates, facilitating translational research, optimization of clinical trials, and others.

In this presentation, I explained summary and effectiveness of QSP approach by showing our case-studies related to safety assessment by using virtual patients, based on mechanism-of-action of compounds. These are 1: risk assessment of drug-induced proarrhythmic effect, 2: drug-induced liver injury (DILI), and other, they have been good practices in my experiences of applying QSP at pharmaceutical company.

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