Determining recommended acceptable intake limits for N-nitrosamine impurities in pharmaceuticals: Development and application of the Carcinogenic Potency Categorization Approach (CPCA)-Reference-Cited by-同舟云学术

Determining recommended acceptable intake limits for N-nitrosamine impurities in pharmaceuticals: Development and application of the Carcinogenic Potency Categorization Approach (CPCA)

Published:2024-06 Issue: Volume:150 Page:105640
ISSN:0273-2300
Container-title:Regulatory Toxicology and Pharmacology
language:en
Short-container-title:Regulatory Toxicology and Pharmacology

Author:

Kruhlak Naomi L.,Schmidt Marianne,Froetschl Roland,Graber Stefan,Haas Bodo,Horne Irene,Horne Stephen,King Sruthi T.,Koval Iryna A.,Kumaran Govindaraj,Langenkamp Anja,McGovern Timothy J.,Peryea Tyler,Sanh Alan,Siqueira Ferreira Aline,van Aerts Leon,Vespa Alisa,Whomsley Rhys

Publisher

Elsevier BV

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5. Practical and science-based strategy for establishing acceptable intakes for drug product N-nitrosamine impurities;Dobo;Chem. Res. Toxicol.,2022

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1. N-nitrosamine impurity risk assessment in pharmaceuticals: Utilizing In vivo mutation relative potency comparison to establish an acceptable intake for NTTP;Regulatory Toxicology and Pharmacology;2024-09

2. Regulatory Highlights;Organic Process Research & Development;2024-08-20

3. Quantum chemical calculations of nitrosamine activation and deactivation pathways for carcinogenicity risk assessment;Frontiers in Pharmacology;2024-07-17