The use of in-silico tools to assist in the practical management of impurities under ICH M7. | December 2019 | | |
Undertaking expert review under the ICH M7 guidelines - Chris Barber | November 2019 |  | |
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 |  |   |