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ICH M7 Publications

The following links provide access to relevant ICH M7 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
Setaria Infographic - Reducing duplication of effortJune 2019pdf fileSetaria
In silico prediction of MutagenicityJune 2019pdf fileSarah NexusDerek Nexus
Use of In Silico Tools for Toxicity Prediction Within ICH M7June 2019pdf fileDerek NexusSarah NexusVitic Nexus
ICH M7 Expert Review ExamplesMay 2019pdf file
ICH M7 Knowledge and Data Sources ManagementMay 2019pdf file
Use of In Silico Tools for Toxicity Prediction Within ICH M7May 2019pdf file
A Suggested ICH M7 Framework Using Lhasa Limited ProductsMay 2019pdf fileZenethVitic NexusMirabilisSarah NexusDerek Nexus
Draft Reflection Paper - Non-Genotoxic ImpuritiesApril 2019pdf file
Improving In Silico Predictions in Developmental and Reproductive ToxicologyApril 2019Derek NexusSarah Nexus
ICH M7 Perception: Unifying Knowledge from Predictions to PurgingMarch 2019pdf fileMirabilisSetariaDerek NexusSarah NexusVitic Nexus
Enhancing the ICH M7 Workflow Through SetariaMarch 2019pdf fileSetaria
Product Update ICGM PresentationMarch 2019pdf fileDerek NexusSarah Nexus
Advance your knowledge of ICH M7 A virtual expert review workshopFebruary 2019Derek NexusSarah Nexus
Principles and procedures for handling out-of-domain and indeterminate results as part of ICH M7 recommended (Q)SAR analysesDecember 2018
Enhancing the ICH M7 Workflow through SetariaDecember 2018pdf fileSetaria
Welcome and Introduction to ICH M7 - ICH M7 India RoadshowsNovember 2018pdf fileDerek NexusSarah NexusVitic Nexus
Sarah Nexus: The Statistical System for ICH M7 - ICH M7 India RoadshowsNovember 2018pdf fileSarah Nexus
Introduction to Mirabilis - ICH M7 India RoadshowsNovember 2018pdf fileMirabilis
ICH M7 Expert Review Workshop - ICH M7 India RoadshowsNovember 2018pdf file
ICH M7: An Industry Perspective - ICH M7 India RoadshowsNovember 2018pdf file
Derek Nexus, Sarah Nexus and Vitic: How they fit into ICH M7 - ICH M7 India RoadshowsNovember 2018pdf fileDerek NexusSarah NexusVitic Nexus
Derek Nexus, The Expert System for ICH M7 - ICH M7 India RoadshowsNovember 2018pdf fileDerek Nexus
Webinar - Mirabilis: Controlling potential genotoxic impurities encountered during API synthesisOctober 2018Mirabilis
Interpreting the Sensitivity and Equivocal Settings in Sarah NexusOctober 2018pdf fileSarah Nexus
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
Toxicity Studies for Degradation Impurities - An Industry PerspectiveJune 2018pdf fileDerek NexusSarah Nexus
Improving Toxicity Predictions through knowledge and data sharingJune 2018pdf fileDerek NexusExcipientsIntermediatesiPiEVitic Nexus
ICH M7 Use CasesJune 2018pdf fileDerek NexusSarah Nexus
Sarah Nexus Strain InformationMarch 2018pdf fileSarah Nexus
Using New Features to Further Interrogate Sarah Nexus PredictionsMarch 2018pdf fileSarah Nexus
Strain profiles: Moving beyond binary Ames classificationMarch 2018pdf fileSarah Nexus
ICH M7 BrochureMarch 2018pdf fileDerek NexusSarah NexusVitic NexusZeneth
Nexus 2.2: An Overview of Key New Features - Sarah NexusJanuary 2018Sarah Nexus
Nexus 2.2: An Overview of Key New Features - Derek and Meteor NexusJanuary 2018Derek NexusMeteor Nexus
Drug Master File (DMF) Holders Preferred PGI Control Strategy Under ICH M7 in Support of Abbreviated New Drug Applications (ANDAs)November 2017pdf file
Industry Perspective on the Application of Expert Chemical Reasoning in the Evaluation of Potential Mutagenic ImpuritiesNovember 2017pdf file
Sarah Nexus: The Statistical System for ICH M7November 2017pdf fileSarah Nexus
Understanding Negative Predictions in Derek Nexus - A Detailed WorkflowNovember 2017pdf fileDerek Nexus
Understanding Negative Predictions in Derek NexusNovember 2017pdf fileDerek Nexus
ICH Quality Guidelines: An Implementation GuideOctober 2017
Manual and Computational Methods for the Evaluation of Statistical Predictions Based on Expert AnalysisOctober 2017pdf fileDerek NexusSarah Nexus
Manual and Computational Methods for the Evaluation of Statistical Predictions Based on Expert AnalysisOctober 2017pdf fileDerek NexusSarah Nexus
Dealing with Out of Domain (Q)SAR Predictions for ICH M7: A Regulatory and Industrial PerspectiveSeptember 2017Derek NexusSarah Nexus
Improving Chemical Space Coverage of an In Silico Prediction System by Targeted Inclusion of Fragments Absent from the Training SetSeptember 2017pdf fileIntermediatesSarah NexusVitic Nexus
A consortium-driven framework to guide the implementation of ICH M7 Option 4 control strategiesAugust 2017Mirabilis

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