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AI In Drug Development: FDA Wants To Know How To Assure Data Integrity, Transparency, Reliability

 
• By Brenda Sandburg

US FDA asks stakeholders how they are addressing bias, reproducibility and data privacy in application of AI/ML. Discussion paper describes current and potential uses of artificial intelligence and machine learning in drug development.

Artificial intelligence
FDA issues discussion paper on use of artificial intelligence and machine learning in drug devleopment • Source: Shutterstock

The US Food and Drug Administration laid out the challenges that need to be addressed in using artificial intelligence and machine learning in drug development, from transparency to the quality, reliability and representativeness of data and monitoring and validation of AL/ML models.

In a discussion paper, entitled "Using Artificial Intelligence & Machine Learning in the Development of Drug & Biological Products,"...

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