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Mutagenic Impurities Publications

The following links provide access to relevant Mutagenic Impurities publications for the last 2 years. If you would like to view older publications, or to refine your search criteria further please search the library.

TitlePublishedTypeProducts
Developing structure-activity relationships for N-nitrosamine activityNovember 2021Derek Nexus
QSAR 2021 Is the bacterial reverse mutation assay an accurate predictor for N-nitrosamine carcinogenicityJune 2021pdf fileVitic Nexus
Predicting N-Nitrosamine Activity from SARJune 2021pdf fileDerek NexusSarah Nexus
1. Qualifying impurities and degradation products: Anvisa's experience and technical improvement - Maria Rodrigues (Slides)May 2021pdf file
1. Qualifying impurities and degradation products: Anvisa's experience and technical improvement - Maria Rodrigues (Video)May 2021Zeneth
2. Risk assessment of potential mutagenic impurities in anti-hypertensive drug products approved in Brazil - Fernanda Waechter (Slides)May 2021pdf fileZeneth
2. Risk assessment of potential mutagenic impurities in anti-hypertensive drug products approved in Brazil - Fernanda Waechter (Video)May 2021Zeneth
3. Case studies on the qualification of impurities - Mariah Ultramari (Slides)May 2021pdf fileZeneth
3. Case studies on the qualification of impurities - Mariah Ultramari (Video)May 2021Zeneth
Use of less-than-lifetime (LTL) durational limits for nitrosamines: Case study of N-Nitrosodiethylamine (NDEA)April 2021
Could purge calculations support your regulatory submissions? (Infographic)October 2020pdf fileMirabilis
Do all nitrosamines pose a significant level of genotoxic risk? (Webinar Presentation Slides)July 2020pdf fileDerek NexusSarah Nexus
Controlling a cohort - Understanding the risk of nitrosamines within drug substance synthesis (Webinar Presentation Slides)July 2020Mirabilis
Mirabilis Cost Saving InfographicApril 2020pdf fileMirabilis
Mirabilis Purge Ratio InfographicMarch 2020pdf fileMirabilis
GSK MI risk assessment process Camicinal at al - 2020 ICH M7 India RoadshowMarch 2020pdf fileDerek NexusSarah NexusVitic Nexus
Management of N-Nitrosamines - Use of Mirabilis based purge calculations to understand MI related risk and control strategy options - RecordingJanuary 2020Mirabilis
Quantitative Analysis of In Vivo Dose-Response Data for Risk Assessment and Regulatory Decision Making - RecordingJanuary 2020
Management of N-Nitrosamines - Use of Mirabilis based purge calculations to understand MI related risk and control strategy optionsJanuary 2020pdf fileMirabilis
Quantitative Analysis of In Vivo Dose-Response Data for Risk Assessment and Regulatory Decision Making - A Case Study of AlkylnitrosaminesJanuary 2020pdf file
Mirabilis - Case Study of a Risk Assessment for ICH M7 Control of ImpuritiesNovember 2019pdf fileMirabilis

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