Simulations Plus, Inc. recently announced that its DILIsym Services (DSS) division released DILIsym® version X (DSX) Beta, the latest iteration of its flagship quantitative systems toxicology (QST) software for predicting and investigating drug-induced liver injury (DILI).
DILIsym modeling aids vital drug development decisions by prevising the potential DILI risk of new drug candidates. The modeling also identifies the biochemical events that contribute to DILI caused by a medicine and can thus predict specific subgroups of patients who are more likely to get DILI from that drug.
DILIsym modeling information helps guide go/no-go decisions on big drug development projects, potentially averting the terrible financial impacts of failed clinical trials or better offering reassurance that DILI will not be an insurmountable barrier to FDA approval. Over the past 12 years, the DILIsym Services division has coordinated the DILI-sim Initiative, a public-private partnership that helped guide the development of the DILIsym software package.
Some of the substantial updates for DSX include:
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A complete software redesign that includes command line and graphical interface options and server/cloud computing capability (HPGL)
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Four new exemplar compounds included with varying clinical presentations:
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PF-04895162 (Generaux 2019)
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Efavirenz
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Anastrozole
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Tamoxifen
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Two new SimCohorts that include variability in susceptibility to liver injury and biomarker-related parameters (ALT and bilirubin)
About Simulations Plus
Simulations Plus, Inc. is a leading drug discovery/development software developer and preclinical and clinical pharmacometric consulting services provider for regulatory submissions and quantitative systems pharmacology models for drug-induced liver, kidney, and nonalcoholic fatty liver disease. Its software is licensed and applied to drug research by major pharmaceutical, biotechnology, chemical, and consumer goods companies as well as regulatory agencies worldwide. With its subsidiaries, Cognigen, DILIsym Services, and Lixoft, Simulations Plus offers solutions that bridge machine learning, physiologically based pharmacokinetics, quantitative systems pharmacology/toxicology, and population PK/PD modeling approaches.