These tools will no longer be maintained as of December 31, 2024. Archived website can be found here. PubMed4Hh GitHub repository can be found here. Contact NLM Customer Service if you have questions.
163 related articles for article (PubMed ID: 38954240)
1. Mutagenic Azido Impurities in Drug Substances: A Perspective. Chourasiya SS; Kathuria D; Kumar V; Ranbhan KJ Ther Innov Regul Sci; 2024 Nov; 58(6):1159-1171. PubMed ID: 38954240 [TBL] [Abstract][Full Text] [Related]
2. Lesson Learnt from Recall of Valsartan and Other Angiotensin II Receptor Blocker Drugs Containing NDMA and NDEA Impurities. Charoo NA; Ali AA; Buha SK; Rahman Z AAPS PharmSciTech; 2019 Apr; 20(5):166. PubMed ID: 30989447 [TBL] [Abstract][Full Text] [Related]
3. Retrospective application of ICH M7 to anti-hypertensive drugs in Brazil: Risk assessment of potentially mutagenic impurities. Waechter F; Falcao Oliveira AA; Borges Shimada AL; Bernes Junior E; de Souza Nascimento E Regul Toxicol Pharmacol; 2024 Aug; 151():105669. PubMed ID: 38936796 [TBL] [Abstract][Full Text] [Related]
4. Nitrosamine Impurities in Pharmaceuticals: An Empirical Review of their Detection, Mechanisms, and Regulatory Approaches. Bhirud D; Agrawal G; Shah H; Patel A; Palkar MB; Bhattacharya S; Prajapati BG Curr Top Med Chem; 2024; 24(6):503-522. PubMed ID: 38321910 [TBL] [Abstract][Full Text] [Related]
5. Impurities in Active Pharmaceutical Ingredients and Drug Products: A Critical Review. Finotti Cordeiro C; Lopardi Franco L; Teixeira Carvalho D; Bonfilio R Crit Rev Anal Chem; 2024 Jul; ():1-21. PubMed ID: 39058576 [TBL] [Abstract][Full Text] [Related]
6. Maximizing use of existing carcinogenicity data to support acceptable intake levels for mutagenic impurities in pharmaceuticals: Learnings from N-nitrosamine case studies. Felter SP; Ponting DJ; Mudd AM; Thomas R; Oliveira AAF Regul Toxicol Pharmacol; 2023 Sep; 143():105459. PubMed ID: 37474097 [TBL] [Abstract][Full Text] [Related]
7. Simultaneous detection of nitrosamines and other sartan-related impurities in active pharmaceutical ingredients by supercritical fluid chromatography. Schmidtsdorff S; Schmidt AH J Pharm Biomed Anal; 2019 Sep; 174():151-160. PubMed ID: 31174128 [TBL] [Abstract][Full Text] [Related]
8. Analytical Methodologies to Detect N-Nitrosamine Impurities in Active Pharmaceutical Ingredients, Drug Products and Other Matrices. Manchuri KM; Shaik MA; Gopireddy VSR; Naziya Sultana ; Gogineni S Chem Res Toxicol; 2024 Sep; 37(9):1456-1483. PubMed ID: 39158368 [TBL] [Abstract][Full Text] [Related]
9. Practical and Science-Based Strategy for Establishing Acceptable Intakes for Drug Product Dobo KL; Kenyon MO; Dirat O; Engel M; Fleetwood A; Martin M; Mattano S; Musso A; McWilliams JC; Papanikolaou A; Parris P; Whritenour J; Yu S; Kalgutkar AS Chem Res Toxicol; 2022 Mar; 35(3):475-489. PubMed ID: 35212515 [TBL] [Abstract][Full Text] [Related]
10. Critical Analysis of Drug Product Recalls due to Nitrosamine Impurities. Bharate SS J Med Chem; 2021 Mar; 64(6):2923-2936. PubMed ID: 33706513 [TBL] [Abstract][Full Text] [Related]
11. The application of structure-based assessment to support safety and chemistry diligence to manage genotoxic impurities in active pharmaceutical ingredients during drug development. Dobo KL; Greene N; Cyr MO; Caron S; Ku WW Regul Toxicol Pharmacol; 2006 Apr; 44(3):282-93. PubMed ID: 16464524 [TBL] [Abstract][Full Text] [Related]
12. An update on the current status and prospects of nitrosation pathways and possible root causes of nitrosamine formation in various pharmaceuticals. Wichitnithad W; Nantaphol S; Noppakhunsomboon K; Rojsitthisak P Saudi Pharm J; 2023 Feb; 31(2):295-311. PubMed ID: 36942272 [TBL] [Abstract][Full Text] [Related]
13. Transitioning to composite bacterial mutagenicity models in ICH M7 (Q)SAR analyses. Landry C; Kim MT; Kruhlak NL; Cross KP; Saiakhov R; Chakravarti S; Stavitskaya L Regul Toxicol Pharmacol; 2019 Dec; 109():104488. PubMed ID: 31586682 [TBL] [Abstract][Full Text] [Related]
14. Are all nitrosamines concerning? A review of mutagenicity and carcinogenicity data. Thresher A; Foster R; Ponting DJ; Stalford SA; Tennant RE; Thomas R Regul Toxicol Pharmacol; 2020 Oct; 116():104749. PubMed ID: 32777431 [TBL] [Abstract][Full Text] [Related]
15. Nitrosamine Contamination in Pharmaceuticals: Threat, Impact, and Control. Tuesuwan B; Vongsutilers V J Pharm Sci; 2021 Sep; 110(9):3118-3128. PubMed ID: 33989680 [TBL] [Abstract][Full Text] [Related]
16. Use of in silico systems and expert knowledge for structure-based assessment of potentially mutagenic impurities. Sutter A; Amberg A; Boyer S; Brigo A; Contrera JF; Custer LL; Dobo KL; Gervais V; Glowienke S; van Gompel J; Greene N; Muster W; Nicolette J; Reddy MV; Thybaud V; Vock E; White AT; Müller L Regul Toxicol Pharmacol; 2013 Oct; 67(1):39-52. PubMed ID: 23669331 [TBL] [Abstract][Full Text] [Related]
17. A Multi-Analyte LC-MS/MS Method for Determination and Quantification of Six Nitrosamine Impurities in Sartans like Azilsartan, Valsartan, Telmisartan, Olmesartan, Losartan and Irbesartan. Gopireddy RR; Maruthapillai A; Mahapatra S J Chromatogr Sci; 2024 Feb; 62(2):147-167. PubMed ID: 35830866 [TBL] [Abstract][Full Text] [Related]
19. Potentially mutagenic impurities: analysis of structural classes and carcinogenic potencies of chemical intermediates in pharmaceutical syntheses supports alternative methods to the default TTC for calculating safe levels of impurities. Galloway SM; Vijayaraj Reddy M; McGettigan K; Gealy R; Bercu J Regul Toxicol Pharmacol; 2013 Aug; 66(3):326-35. PubMed ID: 23688841 [TBL] [Abstract][Full Text] [Related]
20. Resolution of contradiction between in silico predictions and Ames test results for four pharmaceutically relevant impurities. Gunther WC; Kenyon MO; Cheung JR; Dugger RW; Dobo KL Regul Toxicol Pharmacol; 2017 Dec; 91():68-76. PubMed ID: 29061373 [TBL] [Abstract][Full Text] [Related] [Next] [New Search]