Pharmaceutical Technology - March 2021

Pharmaceutical Technology - Regulatory Sourcebook - March 2021

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Pharmaceutical Technology REGULATORY SOURCEBOOK MARCH 2021 35 4. Swissmedic, "Potential Nitrosamine Contamination: Request to Perform a Risk Evaluation" www.swissmedic.ch (Sept 11, 2020). 5. EMA, EMA/369136/2020, Nitrosamine Impurities in Human Me- dicinal Products, Procedure under Article 5(3) of Regulation EC (No) 726/2004, Assessment Report (2020). 6. EMA, EMA/409815/2020 Questions and Answers for Marketing Authorisation Holders/Applicants on the CHMP Opinion for the Ar- ticle 5(3) of Regulation (EC) No 726/2004 Referral on Nitrosamine Impurities in Human Medicinal Products (2020). 7. Health Canada, Questions and Answers: Request to Evaluate the Risk of the Presence of N-Nitrosamine Impurities in Human, Biologi- cal, and Radiopharmaceutical Products (2020). 8. A. Fristachi, and G. Rice, J Water Health, 5 (3) 341–55 (2007). 9. R. Lopez-Rodriguez, et al., Org Process Res Dev 24 (9) 1558–1585 (2020). 10. J.C. Beard and T.M. Swager, Journal of Organic Chemistry 86 (3) 2037–2057 (2021). 11. EMA, EMA/526934/2019 Lessons Learnt from Presence of N-nitro- samine Impurities in Sartan Medicines: Overview and Recommen- dations, Report (2020). 12. A.J. Gushgari, and R.U. Halden, Chemosphere 210 1124–1136 (2018). 13. S.E. Hrudey, et al., Risk Anal 33 (12) 2179–208 (2013). 14. C.A. Krul, et al., Food Chem Toxicol 42 (1) 51–63 (2004). 15. D.J. Snodin, and D.P. Elder, Regul Toxicol Pharmacol 103 325–329 (2019). 16. M.J. Zeilmaker, et al., Toxicol Sci 116 (1) 323-35 (2010). 17. R. Peto, et al., Cancer Res 51 (23 Pt 2) 6415-51 (1991). 18. R. Peto, et al., Cancer Res 51 (23 Pt 2) 6452-69 (1991). 19. J. Akagi, et al., Cancer Sci 106 (5) 529-41 (2015). 20. G.M. Williams, M.J. Iatropoulos, and A.M. Jeffrey, Toxicol Pathol 28 (3) 388–95 (2000). 21. G.M. Williams, et al., Arch Toxicol 73 (7) 394–402 (1999). 22. G.E. Johnson, "Quantitative Analysis of In-Vivo Mutagenicity Dose-Response Data for Risk Assessment and Regulatory Deci- sion-Making: A Case Study of Alkyl Nitrosamines," Webinar 2020. 23. G.E. Johnson, et al., Environ Mol Mutagen 55 (8) 609–23 (2014). 24. H. Druckrey, et al., Z Krebsforsch 69 (2) 103–201 (1967). 25. W. Lijinsky, and H.W. Taylor, J Natl Cancer Inst 62 (2) 407–10 (1979). 26. Health Canada, "Nitrosamines in Pharmaceuticals," Webinar (Jan. 31, 2020). 27. H. Druckery, "Quantitative Aspects in Chemical Carcinogene- sis," in Potential Carcinogenic Hazards from Drugs, R. Truhaut, Ed., 60–78 (Springer-Verlag Berlin, Heidelberg, New York, 1967). 28. S.P. Felter, et al., Crit Rev Toxicol 41 (6) 507–44 (2011). 29. J.B. Guttenplan, IARC Sci Publ (84) 129–31 (1987). 30. A.M. Helguera, et al., Toxicol Appl Pharmacol 231 (2) 197–207 (2008). 31. A.M. Helguera, et al., Toxicol Appl Pharmacol 221 (2) 189–202 (2007). 32. A.M. Helguera, et al., SAR QSAR Environ Res 21 (3-4) 277–304 (2010). 33. J.B. Guttenplan, Mutat Res 186 (2) 81–134 (1987). PT About the authors Timothy Curran,* Timothy_curran@vrtx.com, is execu- tive director in process chemistry, Vertex Pharmaceuticals, and J.P. Bercu is senior director in nonclinical safety and pathobiology, Gilead Sciences; both authors are members of the IQ Consortium. *To whom all correspondence should be addressed • Webcasts • Digital Editions • Whitepapers • Videos • News updates • And more! ONLINE LEARNING Visit our website for the latest e-learning tools in the bio/pharmaceutical industry. Visit us at pharmtech.com PharmTech_eLearning_Ads_072120.indd 1 PharmTech_eLearning_Ads_072120.indd 1 7/21/20 9:52 AM 7/21/20 9:52 AM

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