Following the April 25, 2025 discussion on N-nitroso-esmolol, are there other examples of hospital-use, IV, emergency, or short-term drugs where the AI/MDD approach was considered overly conservative due to the lifetime daily exposure assumption? Given that many treatment scenarios involve less-than-lifetime (LTL) exposure, have regulators accepted alternative risk assessment approaches or limits based on the actual duration of treatment and cumulative patient exposure?
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Welcome, Felipe. Long story short, there are a lot of drugs where an LTL approach can be easily defended. However, it is not accepted at this time. There are a number of initiatives before the FDA & ICH for review and the main obstacle is not agreement with the principle. Rather, it is defining the exact way it will be calculated and enforced for the entire industry.
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Thanks, @jason.brown. That was very clear and helpful. I appreciate the explanation.
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