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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
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
Development of the Mirabilis Knowledge Base for PMI Purge Prediction, Knowledge, Experience and Reaction MiningSeptember 2019pdf fileMirabilis
Improving the predictive performance of in silico aromatic amine mutagencitiy alertsSeptember 2019pdf file
ICH M7 - Risk assessment for mutagenic impurities and control strategiesSeptember 2019Derek NexusMirabilisSarah Nexus
2019 Pharmaceutical Industry and Regulators Symposium Recording - Day 2, Part 1August 2019
2019 Pharmaceutical Industry and Regulators Symposium Recording - Day 2, Part 2August 2019
2019 Pharmaceutical Industry and Regulators Symposium Recording - Day 2, Part 3August 2019
2019 Pharmaceutical Industry and Regulators Symposium Recording - Day 2, Part 4August 2019
2019 Pharmaceutical Industry and Regulators Symposium Recording - Day 1, Part 4August 2019
2019 Pharmaceutical Industry and Regulators Symposium Recording - Day 1, Part 1August 2019
2019 Pharmaceutical Industry and Regulators Symposium Recording - Day 1, Part 2August 2019
In silico prediction of MutagenicityJune 2019pdf fileSarah NexusDerek Nexus
ICHQ3D Implementation: Use of published data driven risk assessmentsJune 2019pdf fileVitic Nexus
RDC53: Challenges on impurities qualificationJune 2019pdf fileDerek NexusSarah NexusVitic NexusZeneth
Controlling potential genotoxic impurities encountered during API synthesisMay 2019pdf fileMirabilis
Modelling Simple Toxicity Endpoints: Alerts, (Q)SARs and BeyondMay 2019Derek NexusMeteor NexusSarah NexusVitic Nexus
How low can you go? An analysis of lowest effective dose in the Ames test.April 2019Vitic Nexus
Mirabilis BrochureDecember 2018pdf fileMirabilis
Webinar - Mirabilis: Controlling potential genotoxic impurities encountered during API synthesisOctober 2018Mirabilis
Meeting report, ICH M7 relevant workshop: use of (Q)SAR systems and expert judgmentSeptember 2018pdf fileDerek NexusSarah Nexus
ICH M7 Overview: Predicting, Assessing, and Controlling Mutagenic Impurities from DegradationJune 2018pdf file
Mirabilis: Using Mirabilis to Support Purge Arguments Under ICH M7June 2018pdf fileMirabilis
Supporting the Assessment of the Purging of Potential Mutagenic Impurities via Analysis of Patent LiteratureMay 2018pdf file
Using New Features to Further Interrogate Sarah Nexus PredictionsMarch 2018pdf fileSarah Nexus
Leveraging Strain Information In Sarah Nexus PredictionsMarch 2018pdf fileSarah Nexus
Drug Master File (DMF) Holders Preferred PGI Control Strategy Under ICH M7 in Support of Abbreviated New Drug Applications (ANDAs)November 2017pdf file
Interpreting ICH Q11: A Risk Assessment Tool for Assessing Starting Material AcceptabilityNovember 2017
Application of RSM Risk Assessment Tool in MirabilisNovember 2017Mirabilis

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