DILIsym is the industry gold standard for quantitative systems toxicology (QST) software designed for the prediction and investigation of drug-induced liver injury (DILI). The one-year renewal provides the FDA with continued access to the DILIsym platform for authorized employees across all FDA divisions.
DILIsym predicts the potential for DILI risk in new molecules and provides deeper insight into the mechanisms responsible for observed DILI responses at various stages of the development process. This allows pharmaceutical development teams to understand their compounds and tailor proposed dosing strategies for efficacy and safety. It also allows the FDA to evaluate the potential DILI risk across multiple populations, which supports informed decision-making regarding drug approvals.
Dr.
'By incorporating disease pathophysiology, clinical presentation, and clinical outcomes into a unified framework, quantitative systems pharmacology (QSP) and toxicology (QST) models are powerful tools for evaluating therapies,' said Dr.
For the last 14 years,
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Serving clients worldwide for more than 25 years,
Forward-Looking Statements
With the exception of historical information, the matters discussed in this press release are forward-looking statements that involve a number of risks and uncertainties. Words like 'believe,' 'expect' and 'anticipate' mean that these are our best estimates as of this writing, but that there can be no assurances that expected or anticipated results or events will actually take place, so our actual future results could differ significantly from those statements. Factors that could cause or contribute to such differences include, but are not limited to: our ability to maintain our competitive advantages, acceptance of new software and improved versions of our existing software by our customers, the general economics of the pharmaceutical industry, our ability to finance growth, our ability to continue to attract and retain highly qualified technical staff, our ability to identify and close acquisitions on terms favorable to the Company, and a sustainable market.
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