Setting limits for N-nitrosamines in drugs: A defined approach based on read-across and structure-activity relationship for N-nitrosopiperazine impurities-Reference-Cited by-同舟云学术

Setting limits for N-nitrosamines in drugs: A defined approach based on read-across and structure-activity relationship for N-nitrosopiperazine impurities

Published:2022-12 Issue: Volume:136 Page:105288
ISSN:0273-2300
Container-title:Regulatory Toxicology and Pharmacology
language:en
Short-container-title:Regulatory Toxicology and Pharmacology

Author:

dos Santos Carlos E. Matos^ORCID,Dorta Daniel Junqueira,de Oliveira Danielle Palma

Funder

FAPESP

CAPES

Publisher

Elsevier BV

Subject

Toxicology,General Medicine

Reference17 articles.

1. ChemMine tools: an online service for analyzing and clustering small molecules;Backman;Nucleic Acids Res.,2011

2. Guia sobre o Controle de Nitrosaminas em Insumos Farmacêuticos Ativos e Medicamentos (Guia nº 50/2021) - Versão 2,2022

3. Developing structure-activity relationships for N-nitrosamine activity;Cross;Computational Toxicology,2021

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

5. Assessment Report - Nitrosamine Impurities in Human Medicinal Products;EMA/369136/2020,2020

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2. Nitrosamine Impurities in Pharmaceuticals: An Empirical Review of their Detection, Mechanisms, and Regulatory Approaches;Current Topics in Medicinal Chemistry;2024-03

3. Developing and validating read-across workflows that enable decision making for toxicity and potency: Case studies with N-nitrosamines;Computational Toxicology;2024-03

4. LC-MS/MS Investigation of nitrosamine impurities in certain Sartan group medicinal products available in Istanbul, Türkiye;Annales Pharmaceutiques Françaises;2024-01

5. Acceptable intakes (AIs) for 11 small molecule N-nitrosamines (NAs);Regulatory Toxicology and Pharmacology;2023-08