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June 3 (Reuters) - The U.S. FDA's Center for Drug Evaluation and Research said on Wednesday it has accepted a letter of intent for an artificial intelligence-based drug development tool designed to help predict drug-induced liver injury.
Drug-induced liver damage is a major cause of trial failures, and current methods do not reliably predict human risk. The U.S. Food and Drug Administration said the tool could potentially help improve early safety ****** sments, reduce reliance on animal testing and support more informed decisions before human trials begin.
Here are some details:
• The tool, an AI-driven digital liver model, has been admitted to the agency's Innovative Science and Technology Approaches for New Drugs (ISTAND) pilot programme.
• The model is designed to ****** s the risk of liver toxicity in new small-molecule drugs by comparing their chemical structures with existing medicines that have known safety profiles.
Drug-induced liver damage is a major cause of trial failures, and current methods do not reliably predict human risk. The U.S. Food and Drug Administration said the tool could potentially help improve early safety ****** sments, reduce reliance on animal testing and support more informed decisions before human trials begin.
Here are some details:
• The tool, an AI-driven digital liver model, has been admitted to the agency's Innovative Science and Technology Approaches for New Drugs (ISTAND) pilot programme.
• The model is designed to ****** s the risk of liver toxicity in new small-molecule drugs by comparing their chemical structures with existing medicines that have known safety profiles.
