Browsing by Subject "Carcinogenicity"

Now showing 1 - 3 of 3
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    Corrigendum to “Nitrosamines crisis in pharmaceuticals − Insights on toxicological implications, root causes and risk assessment: A systematic review” [J. Pharm. Anal. 14 (2024) 100919]
    (Elsevier, 2024) Vikram, Hemanth P. R.; Kumar, Tegginamath Pramod; Kumar, Gunjan; Beeraka, Narasimha M.; Deka, Rajashree; Suhail, Sheik Mohammed; Jat, Sandeep; Bannimath, Namitha; Padmanabhan, Gayatiri; Chandan, Ravandur S.; Kumar, Pramod; Gurupadayya, Bannimath; Pediatrics, School of Medicine
    [This corrects the article DOI: 10.1016/j.jpha.2023.12.009.].
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    Nitrosamines crisis in pharmaceuticals - Insights on toxicological implications, root causes and risk assessment: A systematic review
    (Elsevier, 2024) Vikram, Hemanth P. R.; Kumar, Tegginamath Pramod; Kumar, Gunja; Beeraka, Narasimha M.; Deka, Rajashree; Suhail, Sheik Mohammed; Jat, Sandeep; Bannimath, Namitha; Padmanabha, Gayatiri; Chandan, Ravandur S.; Kumar, Pramod; Gurupadayya, Bannimath; Pediatrics, School of Medicine
    The presence of N-nitroso compounds, particularly N-nitrosamines, in pharmaceutical products has raised global safety concerns due to their significant genotoxic and mutagenic effects. This systematic review investigates their toxicity in active pharmaceutical ingredients (APIs), drug products, and pharmaceutical excipients, along with novel analytical strategies for detection, root cause analysis, reformulation strategies, and regulatory guidelines for nitrosamines. This review emphasizes the molecular toxicity of N-nitroso compounds, focusing on genotoxic, mutagenic, carcinogenic, and other physiological effects. Additionally, it addresses the ongoing nitrosamine crisis, the development of nitrosamine-free products, and the importance of sensitive detection methods and precise risk evaluation. This comprehensive overview will aid molecular biologists, analytical scientists, formulation scientists in research and development sector, and researchers involved in management of nitrosamine-induced toxicity and promoting safer pharmaceutical products.
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    A Review of Perfluorooctanoic Acid Carcinogenicity and Application to Human Risk
    (2010-07-20T16:45:51Z) Stone, Kenneth Lee; Klaunig, James E.; Kamendulis, Lisa M.; Hocevar, Barbara
    Perfluorooctanoic acid (PFOA) is a synthetic organic chemical that consists of an 8 carbon alkyl chain with a terminal carboxyl group in which the carbon-hydrogen bonds have been replaced with carbon-fluorine bonds except at the terminal carboxyl end. This perfluoralkyl carboxylate is a contemporary synthetic chemical that does not occur naturally in the environment and has only seen widespread use within the last 50 years. PFOA is environmentally persistent and is ubiquitously found in human serum. PFOA has been shown to induce a tumor triad consisting of liver adenomas, Leydig cell adenomas and pancreatic acinar cell tumors in male Spraque-Dawley rats. The ability of PFOA to produce tumors in rodents compounded by the fact that PFOA is accumulating not only in those occupationally exposed, but also in the general population, justifies concern about the carcinogenic potential of PFOA in humans. This paper reviews the data from current published research and reveals that some carcinogenic pathways identified in the tumors produced by PFOA in experimental animals may provide a plausible mode of action for human carcinogenesis.