Is your Nitrosamines risk assessment AI-ready?
https://content.govdelivery.com/accounts/USFDA/bulletins/3df85e7
Is your Nitrosamines risk assessment AI-ready?
https://content.govdelivery.com/accounts/USFDA/bulletins/3df85e7
Is AI ready for nitrosamines?
While steps to accelerate the approval of new drugs to market in general is to be applauded I can see risks with this.
It is still possible to get the wrong answers from LLM systems to relatively simple questions around the FDA limits of small nitrosamines. (I was playing around - seeing how easy it would be to get AI to do the start of a review of a product).
I hope that I am not being presumptive that there will still be expert, human oversight on the reviews that come out of any AI system.
If AI applied to nitrosamine topics will create false citations as already happened in legal questions, I will take the pop-corn and I will see the movie…
What Happened to the Lawyer Who Used ChatGPT? Lessons to Learn
I asked ChatGPT about using AI for nitrosamine risk assessment. Do you believe him? I’m worried that one day he’ll start telling me how to choose profitable stocks even though I haven’t asked.
Q. The US Food and Drug Administration (FDA) announced plans to implement AI tools throughout the agency to assist in conducting scientific reviews following the successful completion of a pilot program incorporating generative AI into reviews. How useful is AI in the risk assessment of nitrosamines? Please answer based on the risks, time, and cost benefits of using AI.
A. AI can be highly useful in the risk assessment of nitrosamines—a class of probable human carcinogens—especially when evaluated through the lenses of risk mitigation, time efficiency, and cost benefits. Here’s how AI contributes across these dimensions:
AI adds significant value in nitrosamine risk assessment by enhancing accuracy, reducing evaluation time, and lowering operational costs. While it should not replace expert judgment, AI serves as a powerful decision-support tool that complements and accelerates regulatory science. The FDA’s interest in expanding AI use reflects this strategic benefit.
Would you like a brief example of an AI model used for nitrosamine prediction (like QSAR or Deep Learning tools)?