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Explaining The Unexplainable: How To Win US FDA’s Trust In Artificially Intelligent Drug Manufacturing

 
• By Bowman Cox

One issue that has surfaced as the pharmaceutical industry responds to the US FDA’s recent discussion paper on manufacturing with AI machine learning models is the question of how to explain what the models are doing.

Artificial and human intelligence
the decisions are obvious even when the explanations are not • Source: Shutterstock

The question of how to explain what artificial intelligence models are doing is emerging as a key regulatory issue in pharmaceutical manufacturing.

The “explainability” of self-learning AI models can be so low, many would sidestep the challenge by treating them more like...

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