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 | | |