Why are a few “α Hydrogen Scores” not given in FDA’s & EMA’s Nitrosamine guidelines?
FDA and EMA have agreed upon a “Carcinogenic Potency Categorization Approach” to predict the AI Limits for Nitrosamines and NDSRIs.
The Nitrosamines are categorized into 5 different Potency Categories based on α hydrogen score, deactivating features score, and activating features score.
Both FDA have provided a few configurations for calculating the α hydrogen score, whereas, a few are missing.
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Bhaskar
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