Comment from Dr. Sarjak Pathak
AnonymousOtherIndividual
Summary: The commenter is asking clarifying questions regarding the FDA's requirements for using AI-predicted design spaces and risk-based reductions in traditional DOE trials. They do not take a clear position for or against the proposed guidance.
1.Would risk-based reduction in traditional DOE trials be acceptable if supported by robust AI predictions and targeted validation?
2.What level of model validation and experimental confirmation would FDA require for accepting AI-predicted design spaces?
3.Would FDA accept design spaces primarily based on in-silico predictions supplemented by limited confirmatory studies?