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Publications

The following links provide access to relevant 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.

TitlePublishedTypeProducts
Use of the bacterial reverse mutation assay to predict carcinogenicity of N-nitrosaminesSeptember 2022Derek NexusSarah Nexus
Chapter 3: Control Strategies for Mutagenic ImpuritiesMarch 2022MirabilisDerek NexusSarah Nexus
Chapter 9: Mutagenic Impurities – Assessment of Fate and Control OptionsMarch 2022Derek NexusSarah NexusMirabilis
Chapter 17: Use of Lhasa Limited Products for the In Silico Prediction of Drug ToxicityFebruary 2022Derek NexusSarah NexusMirabilisZeneth
Structural features affecting nitrosamine carcinogenic potencySeptember 2021pdf file
In Silico Prediction of Genotoxicity Current Applications and Future PerspectivesSeptember 2021pdf fileDerek NexusSarah Nexus
Zeneth Member Type InfographicAugust 2021pdf fileZeneth
QSAR 2021 Addressing the global challenge of N-nitrosamine impurity assessmentJune 2021pdf fileDerek NexusMirabilisSarah NexusVitic Nexus
Managing the risk of nitrosamine impuritiesJune 2021
A collaborative benchmarking study to evaluate the newly released Zeneth 8May 2021pdf fileZeneth
1. Qualifying impurities and degradation products: Anvisa's experience and technical improvement - Maria Rodrigues (Slides)May 2021pdf file
1. Qualifying impurities and degradation products: Anvisa's experience and technical improvement - Maria Rodrigues (Video)May 2021Zeneth
2. Risk assessment of potential mutagenic impurities in anti-hypertensive drug products approved in Brazil - Fernanda Waechter (Slides)May 2021pdf fileZeneth
2. Risk assessment of potential mutagenic impurities in anti-hypertensive drug products approved in Brazil - Fernanda Waechter (Video)May 2021Zeneth
3. Case studies on the qualification of impurities - Mariah Ultramari (Slides)May 2021pdf fileZeneth
3. Case studies on the qualification of impurities - Mariah Ultramari (Video)May 2021Zeneth
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 2020pdf fileDerek NexusSarah Nexus
Management of pharmaceutical ICH M7 (Q)SAR predictions – The impact of model updatesNovember 2020Derek NexusSarah NexusVitic Nexus
Could purge calculations support your regulatory submissions? (Infographic)October 2020pdf fileMirabilis
ICH M7 Expert Review Workshop: Resolving common prediction scenarios using automated arguments in Nexus 2.3 (Webinar Presentation Slides)September 2020pdf fileDerek NexusSarah Nexus
Setaria Product BrochureSeptember 2020pdf fileSetaria
Do all nitrosamines pose a significant level of genotoxic risk? (Webinar Presentation Slides)July 2020pdf fileDerek NexusSarah Nexus
Mirabilis Cost Saving InfographicApril 2020pdf fileMirabilis
Vitic Data Sharing BenefitsApril 2020pdf fileVitic Nexus
Mirabilis Purge Ratio InfographicMarch 2020pdf fileMirabilis
Aiding and standardising expert review under ICH M7March 2020pdf file
Aiding and standardising expert review under ICH M7 - RecordingMarch 2020
In silico workflow under ICH M7 - RecordingMarch 2020
ICH M7 Workshop - 2020 ICH M7 India RoadshowsMarch 2020pdf fileDerek NexusSarah NexusZenethVitic NexusSetariaMirabilis
Lhasa and the ICH M7 Guideline - 2020 ICH M7 India RoadshowMarch 2020pdf fileDerek NexusSarah NexusVitic NexusSetariaMirabilis
Hazard Assessment of Potentially Mutagenic Impurities - 2020 ICH M7 India RoadshowsMarch 2020pdf fileDerek NexusSarah Nexus
ICH M7 - Regulatory Updates and Industry Practices - 2020 ICH M7 India RoadshowsMarch 2020pdf fileDerek NexusSarah Nexus
Lhasa Expert Review Developments - 2020 ICH M7 India RoadshowsMarch 2020pdf fileDerek NexusSarah NexusVitic Nexus
Beyond Mutagenicity: Supporting Toxicity Assessments For Other EndpointsJanuary 2020pdf fileDerek Nexus
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 BarberNovember 2019pdf file
ICH M7 Expert Review Examples PresentationSeptember 2019pdf file
2019 Pharmaceutical Industry and Regulators Symposium Recording - Day 2, Part 1August 2019
2019 Pharmaceutical Industry and Regulators Symposium Recording - Day 1, Part 3August 2019
2019 Pharmaceutical Industry and Regulators Symposium Recording - Day 1, Part 4August 2019
2019 Pharmaceutical Industry and Regulators Symposium Recording - Day 1, Part 1August 2019
Setaria Reducing Duplication of Effort InfographicJuly 2019pdf fileSetaria
ICH M7 Expert Review ExamplesMay 2019pdf file
ICH M7 Knowledge and Data Sources ManagementMay 2019pdf file
Draft Reflection Paper - Non-Genotoxic ImpuritiesApril 2019pdf file
Advance your knowledge of ICH M7 A virtual expert review workshopFebruary 2019Derek NexusSarah Nexus
Principles and procedures for handling out-of-domain and indeterminate results as part of ICH M7 recommended (Q)SAR analysesDecember 2018
ICH M7 Expert Review Workshop - ICH M7 India RoadshowsNovember 2018pdf file
ICH M7: An Industry Perspective - ICH M7 India RoadshowsNovember 2018pdf file
ICH M7 Overview: Predicting, Assessing, and Controlling Mutagenic Impurities from DegradationJune 2018pdf file
Nexus 2.2: An Overview of Key New Features - Sarah NexusJanuary 2018Sarah 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
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
A consortium-driven framework to guide the implementation of ICH M7 Option 4 control strategiesAugust 2017Mirabilis
Utility of Published DNA reactivity alertsMay 2017Derek NexusSarah Nexus
Japanese ICH M7 ExamplesMay 2017pdf fileDerek NexusSarah NexusVitic Nexus
Carbamates and ICH M7 classification: Making use of expert knowledgeApril 2017Derek NexusSarah Nexus
ICH M7 Classification WorkflowMarch 2017pdf fileDerek NexusSarah 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
The Liability Load and how Lhasa Limited Focuses on Reducing itNovember 2016pdf fileDerek NexusSarah Nexus
Theoretical Purge Argumentation for Genotoxic ImpuritiesOctober 2016pdf file
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
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
Practical Implementation of (Q)SAR and Expert Review for Compliance with ICH M7 GuidelinesApril 2016pdf file
Undertaking Expert Review under ICH M7 - A Practical GuideDecember 2015pdf fileDerek NexusSarah Nexus
Mutagenicity assessment strategy for pharmaceutical intermediates to aid limit setting for occupational exposureNovember 2015Sarah NexusDerek Nexus
Establishing best practise in the application of expert review of mutagenicity under ICH M7August 2015Derek NexusSarah Nexus
Relationship between the mutagenicity of arylboronic acids and 11B NMR chemical shiftsMay 2015Derek Nexus
A practical application of two in silico systems for identification of potentially mutagenic impuritiesMay 2015Derek NexusSarah Nexus
An evaluation of in-house and off-the-shelf in silico models: Implications on guidance for mutagenicity assessmentApril 2015Derek Nexus
(Q)SAR assessments of potentially mutagenic impurities: A regulatory perspective on the utility of expert knowledge and data submissionMarch 2015
Nexus 2 - Improved functionality to assist in ICH M7 submissionDecember 2014Derek NexusSarah Nexus
Use of in silico systems and expert knowledge for structure-based assessment of potentially mutagenic impuritiesOctober 2013Derek Nexus
An Expert System To Predict the Forced Degradation of Organic MoleculesJuly 2013Zeneth
Latest advances in computational genotoxicity predictionSeptember 2012Derek Nexus
In silico methods combined with expert knowledge rule out mutagenic potential of pharmaceutical impurities: An industry surveyApril 2012
Use of Structure Activity Relationship (SAR) Evaluation as a Critical Tool in the Evaluation of the Genotoxic Potential of ImpuritiesJanuary 2011
A rationale for determining, testing, and controlling specific impurities in pharmaceuticals that possess potential for genotoxicityApril 2006
The application of structure-based assessment to support safety and chemistry diligence to manage genotoxic impurities in active pharmaceutical ingredients during drug developmentApril 2006

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