The FDA’s Center for Drug Evaluation and Research has accepted the first letter of intent for an in silico drug development tool into the agency’s Innovative Science and Technology Approaches for New Drugs qualification program.
The tool, an AI-Driven Digital Liver Model for Prediction of Drug-Induced Liver Injury, is designed to help predict liver toxicity by comparing the chemical structures of new drug candidates with reference drugs that have known liver injury risks, according to a June 3 agency news release. The FDA said the model could complement other methods used to assess liver safety during drug development.
Drug-induced liver injury remains a leading cause of clinical trial termination and drug attrition during the investigational new drug process, according to the FDA. If qualified, the tool could be used to assess drug-induced liver injury risk for small-molecule drug candidates before phase 1 clinical trials.
Acceptance of the letter of intent marks the first step in the agency’s three-step drug development tool qualification process. The developer must next submit a qualification plan followed by a full qualification package before the tool can be considered for qualification.
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