This will be of interest to the formulators, manufacturing and CMC scientists: "FDA and international regulators developed a methodology, the Carcinogenic Potency Categorization Approach (CPCA), that uses the chemical structure of a nitrosamine impurity to recommend AI limits by assignment to 1 of 5 predicted potency categories reflecting carcinogenic risk". The FDA recently posted the details on this:
Development of the Carcinogenic Potency Categorization Approach
Based on a publication: Development and application of the Carcinogenic Potency Categorization Approach (CPCA). Regul Toxicol Pharmacol, 150:105640. https://doi.org/10.1016/j.yrtph.2024.105640
#carcinogenicityRisk#fda #nitrosamines
| U.S. Food and Drug Administration |
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| Development of the Carcinogenic Potency Categorization Approach |
| Approach helps identify nitrosamine acceptable intake limits more efficiently and with greater transparency and predictability, |
| View this on U.S. Food and Drug Administration > |
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Mark Arnold Ph.D., FAAPS
Westampton, NJ
[email protected]Bioanalytical Solution Integration
LinkedIn:
https://www.linkedin.com/in/markearnoldphd/Website & Blog: Bioanalysis & Biomarkers <bioanalysisandbiomarkers.blogspot.com>
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