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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.

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 2017Derek NexusMeteor NexusVitic Nexus
Utility of Published DNA reactivity alertsMay 2017Derek NexusSarah Nexus
Japanese ICH M7 ExamplesMay 2017pdf fileDerek NexusSarah NexusVitic Nexus
Mirabilis: Prediction and assessment of purge factors for potentially mutagenic impurities in a chemical processApril 2017pdf fileMirabilis
Carbamates and ICH M7 classification: Making use of expert knowledgeApril 2017Derek NexusSarah Nexus
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
Distinguishing between expert and statistical systems for application under ICH M7January 2017Derek NexusSarah Nexus
Mirabilis: Scientifically Robust Purge Factor Calculations for PMIs in a Synthetic RouteJanuary 2017Mirabilis
Advantages in Utilizing an Integrated In Silico Solution for ICH M7 Expert ReviewNovember 2016pdf fileDerek NexusMeteor NexusSarah NexusVitic NexusZeneth
Theoretical Purge Argumentation for Genotoxic ImpuritiesOctober 2016pdf file
ICH M7 Classification and the involvement of (Q)SAR methodsOctober 2016pdf fileDerek NexusSarah Nexus
Are these alerting structures an appropriate aid in the expert analysis of two complementary QSAR predictions?October 2016Derek NexusSarah Nexus
Carbamates, QSAR predictions and ICH M7 classification; making use of expert knowledgeOctober 2016Derek NexusSarah Nexus
Mirabilis - A Semi-Automated Tool for Predicting and Managing the Purging of Mutagenic Impurities During SynthesisSeptember 2016pdf fileMirabilis
An Automated Classification Workflow to Assist Expert Assessment and Regulatory Submission for ICH M7August 2016pdf fileDerek NexusSarah Nexus
3-Fluoro-4-Phenylaniline - Positive - PositiveAugust 2016Derek NexusSarah Nexus
Phenyltrifluoroborate - Positive - Out Of DomainAugust 2016Derek NexusSarah Nexus
N-Propyl Triazoline - Positive - NegativeAugust 2016Derek NexusSarah Nexus
Methyl Sulfate - Negative - EquivocalAugust 2016Derek NexusSarah Nexus
Tolfenamic Acid - Negative - NegativeAugust 2016Derek NexusSarah Nexus
Data Dos and Don'ts in Building Statistical Models For Ames MutagenicityJune 2016pdf fileSarah Nexus
The use of in silico tools to support expert review under ICH M7June 2016pdf fileDerek NexusSarah Nexus
Mutagenicity Prediction Using In Silico Methods: Gigabyte-Sized Petri DishesJune 2016pdf fileDerek NexusZenethVitic NexusSarah NexusMirabilisMeteor Nexus
Using In Silico Software to Generate an ICH M7 Submission and Expert ReviewMay 2016pdf file
Practical Implementation of (Q)SAR and Expert Review for Compliance with ICH M7 GuidelinesApril 2016pdf file
Lhasa Data Sharing Experience at Bristol-Myers SquibbApril 2016pdf fileDerek Nexus
In Silico Drug Degradation Assessment in Early Phase DevelopmentMarch 2016pdf fileZeneth
ICH M7 - Worked Examples using the new Nexus workflowMarch 2016pdf fileDerek NexusSarah Nexus
Mutagenic impurities: predicting alerting structures using in silico toolsMarch 2016pdf fileSarah NexusDerek Nexus
Implementation of ICH M7 Recommended (Q)SAR AnalysesMarch 2016pdf fileDerek NexusSarah NexusVitic NexusZeneth
Advantages in Utilizing an Integrated In Silico Solution for ICH M7 Expert ReviewMarch 2016pdf fileDerek NexusMirabilisSarah NexusVitic NexusZeneth
ICH M7 BrochureMarch 2016pdf fileDerek NexusSarah NexusVitic NexusZeneth
Mutagenicity assessment strategy for pharmaceutical intermediates to aid limit setting for occupational exposureJanuary 2016Sarah NexusDerek Nexus
Undertaking Expert Review under ICH M7 - A Practical GuideDecember 2015pdf fileDerek NexusSarah Nexus

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