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Publications

The following links provide access to relevant 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
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
Mirabilis: Prediction and assessment of purge factors for potentially mutagenic impurities in a chemical processApril 2017pdf fileMirabilis
ICH M7 Classification WorkflowMarch 2017pdf fileDerek NexusSarah Nexus
Expert review of the mutagenicity of carbamates - using (Q)SAR predictions for ICH M7 classificationMarch 2017pdf fileDerek NexusSarah NexusVitic Nexus
Regulatory Submission Under ICH M7 - Application of Expert ReviewMarch 2017pdf fileDerek NexusSarah Nexus
In Silico Strategies to Assess Potentially Mutagenic Impurities Under ICH M7March 2017pdf fileDerek NexusSarah NexusMirabilisVitic Nexus
Using Sarah Nexus Effectively: Intuitive Model Building and Interpreting ConfidenceFebruary 2017Sarah Nexus
Mirabilis: Scientifically Robust Purge Factor Calculations for PMIs in a Synthetic RouteJanuary 2017Mirabilis
Mirabilis - A Semi-Automated Tool for Predicting and Managing the Purging of Mutagenic Impurities During SynthesisSeptember 2016pdf fileMirabilis
Data Dos and Don'ts in Building Statistical Models For Ames MutagenicityJune 2016pdf fileSarah Nexus
Investigation of patent and grant data to support purge calculations of DNA reactive (mutagenic) impurities used for risk assessmentJune 2016pdf fileMirabilis
Mutagenicity Prediction Using In Silico Methods: Gigabyte-Sized Petri DishesJune 2016pdf fileDerek NexusZenethVitic NexusSarah NexusMirabilisMeteor Nexus
Using Data to make Predictions in the Risk Assessment of Mutagenic ImpuritiesMarch 2016pdf fileMirabilis
Mutagenic impurities: predicting alerting structures using in silico toolsMarch 2016pdf fileSarah NexusDerek Nexus

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