| ICH M7 Expert Review Examples Presentation | September 2019 |  | |
| ICH M7 - Risk assessment for mutagenic impurities and control strategies | September 2019 | |    |
| 2019 Pharmaceutical Industry and Regulators Symposium Recording - Day 2, Part 1 | August 2019 | | |
| 2019 Pharmaceutical Industry and Regulators Symposium Recording - Day 1, Part 3 | August 2019 | | |
| 2019 Pharmaceutical Industry and Regulators Symposium Recording - Day 1, Part 4 | August 2019 | | |
| 2019 Pharmaceutical Industry and Regulators Symposium Recording - Day 1, Part 1 | August 2019 | | |
| Setaria Reducing Duplication of Effort Infographic | July 2019 | |  |
| Toxicity Evaluation of Degradation Products | July 2019 | |  |
| (Q)SAR Evaluation of Drug Impurities from the US FDA Scientific Perspective | July 2019 | | |
| ICH M7 Perception Webinar | June 2019 | | |
| In silico prediction of Mutagenicity | June 2019 | | |
| Use of In Silico Tools for Toxicity Prediction Within ICH M7 | June 2019 | |  |
| ICH M7 Expert Review Examples | May 2019 | | |
| ICH M7 Knowledge and Data Sources Management | May 2019 | | |
| Use of In Silico Tools for Toxicity Prediction Within ICH M7 | May 2019 | | |
| A Suggested ICH M7 Framework Using Lhasa Limited Products | May 2019 | | |
| Draft Reflection Paper - Non-Genotoxic Impurities | April 2019 | | |
| Improving In Silico Predictions in Developmental and Reproductive Toxicology | April 2019 | | |
| ICH M7 Perception: Unifying Knowledge from Predictions to Purging | March 2019 | | |
| Enhancing the ICH M7 Workflow Through Setaria | March 2019 | | |
| Product Update ICGM Presentation | March 2019 | | |
| Advance your knowledge of ICH M7 A virtual expert review workshop | February 2019 | | |
| Principles and procedures for handling out-of-domain and indeterminate results as part of ICH M7 recommended (Q)SAR analyses | December 2018 | | |
| Enhancing the ICH M7 Workflow through Setaria | December 2018 | | |
| Welcome and Introduction to ICH M7 - ICH M7 India Roadshows | November 2018 | | |
| Sarah Nexus: The Statistical System for ICH M7 - ICH M7 India Roadshows | November 2018 | | |
| Introduction to Mirabilis - ICH M7 India Roadshows | November 2018 | | |
| ICH M7 Expert Review Workshop - ICH M7 India Roadshows | November 2018 | | |
| ICH M7: An Industry Perspective - ICH M7 India Roadshows | November 2018 | | |
| Derek Nexus, Sarah Nexus and Vitic: How they fit into ICH M7 - ICH M7 India Roadshows | November 2018 | | |
| Derek Nexus, The Expert System for ICH M7 - ICH M7 India Roadshows | November 2018 | | |
| Webinar - Mirabilis: Controlling potential genotoxic impurities encountered during API synthesis | October 2018 | | |
| Interpreting the Sensitivity and Equivocal Settings in Sarah Nexus | October 2018 | | |
| Meeting report, ICH M7 relevant workshop: use of (Q)SAR systems and expert judgment | September 2018 | | |
| ICH M7 Overview: Predicting, Assessing, and Controlling Mutagenic Impurities from Degradation | June 2018 | | |
| Mirabilis: Using Mirabilis to Support Purge Arguments Under ICH M7 | June 2018 | | |
| Toxicity Studies for Degradation Impurities - An Industry Perspective | June 2018 | | |
| Improving Toxicity Predictions through knowledge and data sharing | June 2018 | |    |
| ICH M7 Use Cases | June 2018 | | |
| Sarah Nexus Strain Information | March 2018 | | |
| Using New Features to Further Interrogate Sarah Nexus Predictions | March 2018 | | |
| Strain profiles: Moving beyond binary Ames classification | March 2018 | | |
| ICH M7 Brochure | March 2018 | | |
| Nexus 2.2: An Overview of Key New Features - Sarah Nexus | January 2018 | | |
| Nexus 2.2: An Overview of Key New Features - Derek and Meteor Nexus | January 2018 | |  |
| Drug Master File (DMF) Holders Preferred PGI Control Strategy Under ICH M7 in Support of Abbreviated New Drug Applications (ANDAs) | November 2017 | | |
| Industry Perspective on the Application of Expert Chemical Reasoning in the Evaluation of Potential Mutagenic Impurities | November 2017 | | |
| Sarah Nexus: The Statistical System for ICH M7 | November 2017 | | |
| Understanding Negative Predictions in Derek Nexus - A Detailed Workflow | November 2017 | | |
| Understanding Negative Predictions in Derek Nexus | November 2017 | | |
| ICH Quality Guidelines: An Implementation Guide | October 2017 | | |
| Manual and Computational Methods for the Evaluation of Statistical Predictions Based on Expert Analysis | October 2017 | | |
| Manual and Computational Methods for the Evaluation of Statistical Predictions Based on Expert Analysis | October 2017 | | |
| Dealing with Out of Domain (Q)SAR Predictions for ICH M7: A Regulatory and Industrial Perspective | September 2017 | | |
| Improving Chemical Space Coverage of an In Silico Prediction System by Targeted Inclusion of Fragments Absent from the Training Set | September 2017 | | |
| A consortium-driven framework to guide the implementation of ICH M7 Option 4 control strategies | August 2017 | | |
| Utility of Published DNA reactivity alerts | May 2017 | | |
| Japanese ICH M7 Examples | May 2017 | | |
| Mirabilis: Prediction and assessment of purge factors for potentially mutagenic impurities in a chemical process | April 2017 | | |
| Carbamates and ICH M7 classification: Making use of expert knowledge | April 2017 | | |
| ICH M7 Classification Workflow | March 2017 | | |
| Expert review of the mutagenicity of carbamates - using (Q)SAR predictions for ICH M7 classification | March 2017 | | |
| Regulatory Submission Under ICH M7 - Application of Expert Review | March 2017 | | |
| In Silico Strategies to Assess Potentially Mutagenic Impurities Under ICH M7 | March 2017 | | |
| Using Sarah Nexus Effectively: Intuitive Model Building and Interpreting Confidence | February 2017 | | |
| Distinguishing between expert and statistical systems for application under ICH M7 | January 2017 | | |
| Mirabilis: Scientifically Robust Purge Factor Calculations for PMIs in a Synthetic Route | January 2017 | | |
| Advantages in Utilizing an Integrated In Silico Solution for ICH M7 Expert Review | November 2016 | | |
| The Liability Load and how Lhasa Limited Focuses on Reducing it | November 2016 | | |
| Theoretical Purge Argumentation for Genotoxic Impurities | October 2016 | | |
| ICH M7 Classification and the involvement of (Q)SAR methods | October 2016 | | |
| Are these alerting structures an appropriate aid in the expert analysis of two complementary QSAR predictions? | October 2016 | | |
| Carbamates, QSAR predictions and ICH M7 classification; making use of expert knowledge | October 2016 | | |
| Mirabilis - A Semi-Automated Tool for Predicting and Managing the Purging of Mutagenic Impurities During Synthesis | September 2016 | | |
| An Automated Classification Workflow to Assist Expert Assessment and Regulatory Submission for ICH M7 | August 2016 | | |
| 3-Fluoro-4-Phenylaniline - Positive - Positive | August 2016 | | |
| Phenyltrifluoroborate - Positive - Out Of Domain | August 2016 | | |
| N-Propyl Triazoline - Positive - Negative | August 2016 | | |
| Methyl Sulfate - Negative - Equivocal | August 2016 | | |
| Tolfenamic Acid - Negative - Negative | August 2016 | | |
| Data Dos and Don'ts in Building Statistical Models For Ames Mutagenicity | June 2016 | | |
| The use of in silico tools to support expert review under ICH M7 | June 2016 | | |
| Mutagenicity Prediction Using In Silico Methods: Gigabyte-Sized Petri Dishes | June 2016 | | |
| Using In Silico Software to Generate an ICH M7 Submission and Expert Review | May 2016 | | |
| Practical Implementation of (Q)SAR and Expert Review for Compliance with ICH M7 Guidelines | April 2016 | | |
| Lhasa Data Sharing Experience at Bristol-Myers Squibb | April 2016 | | |
| In Silico Drug Degradation Assessment in Early Phase Development | March 2016 | | |
| ICH M7 - Worked Examples using the new Nexus workflow | March 2016 | | |
| Mutagenic impurities: predicting alerting structures using in silico tools | March 2016 | | |
| Implementation of ICH M7 Recommended (Q)SAR Analyses | March 2016 | | |
| Advantages in Utilizing an Integrated In Silico Solution for ICH M7 Expert Review | March 2016 | | |
| Mutagenicity assessment strategy for pharmaceutical intermediates to aid limit setting for occupational exposure | January 2016 | | |
| Undertaking Expert Review under ICH M7 - A Practical Guide | December 2015 | | |
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