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Global Agencies Seek Clearer Steer On AI In Drug Development & Regulation

Report Describes Possible Use Of Apps For CNS Drugs, Pharmacovigilance

 
• By Ian Schofield

Regulators’ experiences and two hypothetical case studies form the basis of a set of recommendations on the use of artificial intelligence in areas such as safety signal detection and improving decision making, which have just been published by the International Coalition of Medicines Regulatory Authorities.

AI with computer data stream background
Artificial intelligence has many potential uses in drug development and regulation • Source: Alamy

A group of international regulators has called for a permanent working group to be set up to discuss the challenges posed by the use of artificial intelligence in medicines regulation and says that guidance might also be needed on the contribution of AI to the development and use of medicines for treatment and diagnosis.

AI tools such as statistical models, algorithms and self-modifying systems are increasingly being employed throughout the drug development pathway, from target validation and identification of biomarkers, to compound screening and...

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