An automated carcinogenic potency categorization approach for nitrosamine drug substance-related impurities
Author:
Affiliation:
1. Suzhou Novartis Technical Development Co., Ltd, Changshu, Jiangsu 215537, China
Abstract
Publisher
Royal Society of Chemistry (RSC)
Subject
Pollution,Environmental Chemistry
Link
http://pubs.rsc.org/en/content/articlepdf/2024/GC/D3GC03478J
Reference13 articles.
1. FDA announces voluntary recall of several medicines containing valsartan following detection of an impurity, https://www.fda.gov/news-events/press-announcements/fda-announces-voluntary-recall-several-medicines-containing-valsartan-following-detection-impurity
2. Information on Nitrosamines for Marketing Authorisation Holders; EMA/189634/2019 . European Medicines Agency , 2019
3. The Nitrosamine “Saga”: Lessons Learned from Five Years of Scrutiny
4. Formation of N-Nitrosamine Drug Substance Related Impurities in Medicines: A Regulatory Perspective on Risk Factors and Mitigation Strategies
5. Pathways for N-Nitroso Compound Formation: Secondary Amines and Beyond
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1. AI in Predictive Toxicology;Advances in Medical Technologies and Clinical Practice;2024-09-27
2. Analytical Methodologies to Detect N-Nitrosamine Impurities in Active Pharmaceutical Ingredients, Drug Products and Other Matrices;Chemical Research in Toxicology;2024-08-19
3. Determining recommended acceptable intake limits for N-nitrosamine impurities in pharmaceuticals: Development and application of the Carcinogenic Potency Categorization Approach (CPCA);Regulatory Toxicology and Pharmacology;2024-06
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