| Chapter 3: Control Strategies for Mutagenic Impurities | March 2022 | |    |
| Chapter 9: Mutagenic Impurities – Assessment of Fate and Control Options | March 2022 | | |
| Chapter 17: Use of Lhasa Limited Products for the In Silico Prediction of Drug Toxicity | February 2022 | |  |
| Structural features affecting nitrosamine carcinogenic potency | September 2021 |  | |
| In Silico Prediction of Genotoxicity Current Applications and Future Perspectives | September 2021 | | |
| Zeneth Member Type Infographic | August 2021 | | |
| QSAR 2021 Addressing the global challenge of N-nitrosamine impurity assessment | June 2021 | |  |
| Managing the risk of nitrosamine impurities | June 2021 | | |
| A collaborative benchmarking study to evaluate the newly released Zeneth 8 | May 2021 | | |
| 1. Qualifying impurities and degradation products: Anvisa's experience and technical improvement - Maria Rodrigues (Slides) | May 2021 | | |
| 1. Qualifying impurities and degradation products: Anvisa's experience and technical improvement - Maria Rodrigues (Video) | May 2021 | | |
| 2. Risk assessment of potential mutagenic impurities in anti-hypertensive drug products approved in Brazil - Fernanda Waechter (Slides) | May 2021 | | |
| 2. Risk assessment of potential mutagenic impurities in anti-hypertensive drug products approved in Brazil - Fernanda Waechter (Video) | May 2021 | | |
| 3. Case studies on the qualification of impurities - Mariah Ultramari (Slides) | May 2021 | | |
| 3. Case studies on the qualification of impurities - Mariah Ultramari (Video) | May 2021 | | |
| Use of less-than-lifetime (LTL) durational limits for nitrosamines: Case study of N-Nitrosodiethylamine (NDEA) | April 2021 | | |
| Nexus ICH M7 Expert Review Support Functionality (an infographic) | December 2020 | | |
| Management of pharmaceutical ICH M7 (Q)SAR predictions – The impact of model updates | November 2020 | | |
| Could purge calculations support your regulatory submissions? (Infographic) | October 2020 | | |
| ICH M7 Expert Review Workshop: Resolving common prediction scenarios using automated arguments in Nexus 2.3 (Webinar Presentation Slides) | September 2020 | | |
| Setaria Product Brochure | September 2020 | |  |
| Do all nitrosamines pose a significant level of genotoxic risk? (Webinar Presentation Slides) | July 2020 | | |
| ICH M7 Workshop Japanese ICGM 2019 | July 2020 | | |
| Mirabilis Cost Saving Infographic | April 2020 | | |
| Vitic Data Sharing Benefits | April 2020 | | |
| Mirabilis Purge Ratio Infographic | March 2020 | | |
| Aiding and standardising expert review under ICH M7 | March 2020 | | |
| In silico workflow under ICH M7 | March 2020 | | |
| Aiding and standardising expert review under ICH M7 - Recording | March 2020 | | |
| In silico workflow under ICH M7 - Recording | March 2020 | | |
| Setaria - Managing Predictions, Data and Expert Review under ICH M7 | March 2020 | | |
| ICH M7 Workshop - 2020 ICH M7 India Roadshows | March 2020 | | |
| Predictions, Data and ICH M7 - 2020 ICH M7 India Roadshows | March 2020 | | |
| Lhasa and the ICH M7 Guideline - 2020 ICH M7 India Roadshow | March 2020 | | |
| Hazard Assessment of Potentially Mutagenic Impurities - 2020 ICH M7 India Roadshows | March 2020 | | |
| ICH M7 - Regulatory Updates and Industry Practices - 2020 ICH M7 India Roadshows | March 2020 | | |
| Lhasa Expert Review Developments - 2020 ICH M7 India Roadshows | March 2020 | | |
| Beyond Mutagenicity: Supporting Toxicity Assessments For Other Endpoints | January 2020 | | |
| 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 | | |
| The Liability Load and how Lhasa Limited Focuses on Reducing it | November 2016 | | |
| Theoretical Purge Argumentation for Genotoxic Impurities | 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 | | |
| 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 | | |
| Mutagenicity Prediction Using In Silico Methods: Gigabyte-Sized Petri Dishes | June 2016 | | |
| Practical Implementation of (Q)SAR and Expert Review for Compliance with ICH M7 Guidelines | April 2016 | | |
| Mutagenic impurities: predicting alerting structures using in silico tools | March 2016 | | |
| Undertaking Expert Review under ICH M7 - A Practical Guide | December 2015 | | |
| Mutagenicity assessment strategy for pharmaceutical intermediates to aid limit setting for occupational exposure | November 2015 | | |
| Establishing best practise in the application of expert review of mutagenicity under ICH M7 | August 2015 | | |
| Relationship between the mutagenicity of arylboronic acids and 11B NMR chemical shifts | May 2015 | | |
| A practical application of two in silico systems for identification of potentially mutagenic impurities | May 2015 | | |
| An evaluation of in-house and off-the-shelf in silico models: Implications on guidance for mutagenicity assessment | April 2015 | | |
| (Q)SAR assessments of potentially mutagenic impurities: A regulatory perspective on the utility of expert knowledge and data submission | March 2015 | | |
| Nexus 2 - Improved functionality to assist in ICH M7 submission | December 2014 | | |
| Benchmarking Assessment of Salmonella Mutagenicity QSAR Models for Potential Use Under ICH M7.pdf | March 2014 | | |
| Use of in silico systems and expert knowledge for structure-based assessment of potentially mutagenic impurities | October 2013 | | |
| An Expert System To Predict the Forced Degradation of Organic Molecules | July 2013 | | |
| Latest advances in computational genotoxicity prediction | September 2012 | | |
| In silico methods combined with expert knowledge rule out mutagenic potential of pharmaceutical impurities: An industry survey | April 2012 | | |
| Use of Structure Activity Relationship (SAR) Evaluation as a Critical Tool in the Evaluation of the Genotoxic Potential of Impurities | January 2011 | | |
| A rationale for determining, testing, and controlling specific impurities in pharmaceuticals that possess potential for genotoxicity | April 2006 | | |
| The application of structure-based assessment to support safety and chemistry diligence to manage genotoxic impurities in active pharmaceutical ingredients during drug development | April 2006 | | |
shared knowledge shared progress
Nitrites in Excipients data release: Supporting more scientifically driven nitrosamine risk assessments
Nitrites in Excipients Data Sharing Consortium: Supporting Nitrosamine Risk Assessment
5 things you should know about the data in the Lhasa Carcinogenicity Database (LCDB)
