Lhasa Limited shared knowledge shared progress

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
Improving In Silico Predictions in Developmental and Reproductive ToxicologyApril 2019Derek NexusSarah Nexus
ICH M7 Perception: Unifying Knowledge from Predictions to PurgingMarch 2019pdf fileMirabilisSetariaDerek NexusSarah NexusVitic Nexus
Enhancing the ICH M7 Workflow Through SetariaMarch 2019pdf fileSetaria
Product Update ICGM PresentationMarch 2019pdf fileDerek NexusSarah Nexus
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
Enhancing the ICH M7 Workflow through SetariaDecember 2018pdf fileSetaria
Welcome and Introduction to ICH M7 - ICH M7 India RoadshowsNovember 2018pdf fileDerek NexusSarah NexusVitic Nexus
Sarah Nexus: The Statistical System for ICH M7 - ICH M7 India RoadshowsNovember 2018pdf fileSarah Nexus
Introduction to Mirabilis - ICH M7 India RoadshowsNovember 2018pdf fileMirabilis
ICH M7 Expert Review Workshop - ICH M7 India RoadshowsNovember 2018pdf file
ICH M7: An Industry Perspective - ICH M7 India RoadshowsNovember 2018pdf file
Derek Nexus, Sarah Nexus and Vitic: How they fit into ICH M7 - ICH M7 India RoadshowsNovember 2018pdf fileDerek NexusSarah NexusVitic Nexus
Derek Nexus, The Expert System for ICH M7 - ICH M7 India RoadshowsNovember 2018pdf fileDerek Nexus
Webinar - Mirabilis: Controlling potential genotoxic impurities encountered during API synthesisOctober 2018Mirabilis
Interpreting the Sensitivity and Equivocal Settings in Sarah NexusOctober 2018pdf fileSarah Nexus
Meeting report, ICH M7 relevant workshop: use of (Q)SAR systems and expert judgmentSeptember 2018pdf fileDerek NexusSarah Nexus
ICH M7 Overview: Predicting, Assessing, and Controlling Mutagenic Impurities from DegradationJune 2018pdf file
Mirabilis: Using Mirabilis to Support Purge Arguments Under ICH M7June 2018pdf fileMirabilis
Toxicity Studies for Degradation Impurities - An Industry PerspectiveJune 2018pdf fileDerek NexusSarah Nexus
Improving Toxicity Predictions through knowledge and data sharingJune 2018pdf fileDerek NexusExcipientsIntermediatesiPiEVitic Nexus
ICH M7 Use CasesJune 2018pdf fileDerek NexusSarah Nexus
Sarah Nexus Strain InformationMarch 2018pdf fileSarah Nexus
Using New Features to Further Interrogate Sarah Nexus PredictionsMarch 2018pdf fileSarah Nexus
Strain profiles: Moving beyond binary Ames classificationMarch 2018pdf fileSarah Nexus
ICH M7 BrochureMarch 2018pdf fileDerek NexusSarah NexusVitic NexusZeneth
A Suggested ICH M7 Framework Using Lhasa Limited ProductsMarch 2018pdf fileZenethVitic NexusMirabilisSarah NexusDerek Nexus
Nexus 2.2: An Overview of Key New Features - Sarah NexusJanuary 2018Sarah Nexus
Nexus 2.2: An Overview of Key New Features - Derek and Meteor NexusJanuary 2018Derek NexusMeteor 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
Sarah Nexus: The Statistical System for ICH M7November 2017pdf fileSarah Nexus
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
Manual and Computational Methods for the Evaluation of Statistical Predictions Based on Expert AnalysisOctober 2017pdf fileDerek NexusSarah Nexus
Manual and Computational Methods for the Evaluation of Statistical Predictions Based on Expert AnalysisOctober 2017pdf fileDerek NexusSarah Nexus
Dealing with Out of Domain (Q)SAR Predictions for ICH M7: A Regulatory and Industrial PerspectiveSeptember 2017Derek NexusSarah Nexus
Improving Chemical Space Coverage of an In Silico Prediction System by Targeted Inclusion of Fragments Absent from the Training SetSeptember 2017pdf fileIntermediatesSarah NexusVitic Nexus
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
Mirabilis: Prediction and assessment of purge factors for potentially mutagenic impurities in a chemical processApril 2017pdf fileMirabilis
Carbamates and ICH M7 classification: Making use of expert knowledgeApril 2017Derek NexusSarah Nexus
ICH M7 Classification WorkflowMarch 2017pdf fileDerek NexusSarah Nexus
Expert review of the mutagenicity of carbamates - using (Q)SAR predictions for ICH M7 classificationMarch 2017pdf fileDerek NexusSarah NexusVitic Nexus
Regulatory Submission Under ICH M7 - Application of Expert ReviewMarch 2017pdf fileDerek NexusSarah Nexus
In Silico Strategies to Assess Potentially Mutagenic Impurities Under ICH M7March 2017pdf fileDerek NexusSarah NexusMirabilisVitic 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
Mirabilis: Scientifically Robust Purge Factor Calculations for PMIs in a Synthetic RouteJanuary 2017Mirabilis
Advantages in Utilizing an Integrated In Silico Solution for ICH M7 Expert ReviewNovember 2016pdf fileDerek NexusMeteor NexusSarah NexusVitic NexusZeneth
The Liability Load and how Lhasa Limited Focuses on Reducing itNovember 2016pdf fileDerek NexusSarah Nexus
Theoretical Purge Argumentation for Genotoxic ImpuritiesOctober 2016pdf file
ICH M7 Classification and the involvement of (Q)SAR methodsOctober 2016pdf fileDerek NexusSarah Nexus
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
Mirabilis - A Semi-Automated Tool for Predicting and Managing the Purging of Mutagenic Impurities During SynthesisSeptember 2016pdf fileMirabilis
An Automated Classification Workflow to Assist Expert Assessment and Regulatory Submission for ICH M7August 2016pdf fileDerek 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
Data Dos and Don'ts in Building Statistical Models For Ames MutagenicityJune 2016pdf fileSarah Nexus
The use of in silico tools to support expert review under ICH M7June 2016pdf fileDerek NexusSarah Nexus
Mutagenicity Prediction Using In Silico Methods: Gigabyte-Sized Petri DishesJune 2016pdf fileDerek NexusZenethVitic NexusSarah NexusMirabilisMeteor Nexus
Using In Silico Software to Generate an ICH M7 Submission and Expert ReviewMay 2016pdf file
Practical Implementation of (Q)SAR and Expert Review for Compliance with ICH M7 GuidelinesApril 2016pdf file
Lhasa Data Sharing Experience at Bristol-Myers SquibbApril 2016pdf fileDerek Nexus
In Silico Drug Degradation Assessment in Early Phase DevelopmentMarch 2016pdf fileZeneth
ICH M7 - Worked Examples using the new Nexus workflowMarch 2016pdf fileDerek NexusSarah Nexus
Mutagenic impurities: predicting alerting structures using in silico toolsMarch 2016pdf fileSarah NexusDerek Nexus
Implementation of ICH M7 Recommended (Q)SAR AnalysesMarch 2016pdf fileDerek NexusSarah NexusVitic NexusZeneth
Advantages in Utilizing an Integrated In Silico Solution for ICH M7 Expert ReviewMarch 2016pdf fileDerek NexusMirabilisSarah NexusVitic NexusZeneth
Mutagenicity assessment strategy for pharmaceutical intermediates to aid limit setting for occupational exposureJanuary 2016Sarah NexusDerek Nexus
Undertaking Expert Review under ICH M7 - A Practical GuideDecember 2015pdf fileDerek NexusSarah Nexus
Mirabilis: a tool for predicting the purging of mutagenic impurities during synthesisNovember 2015pdf fileMirabilis
ICH M7 Workflow.pdfNovember 2015pdf fileDerek NexusSarah NexusVitic Nexus
In silico approaches to knowledge and data sharingOctober 2015pdf fileDerek NexusSarah Nexus
Lhasa ICH M7 databaseOctober 2015
Establishing best practise in the application of expert review of mutagenicity under ICH M7August 2015Derek NexusSarah Nexus
Computational approaches to managing mutagenicity risk for ICHM7 and beyondJuly 2015pdf fileDerek NexusMeteor NexusMirabilisSarah NexusVitic Nexus
Generics Perspective: Success Strategies for Genotoxic Impurity Identification, Assessment and ControlJune 2015pdf fileDerek 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
Comparative assessment of several in silico systems and models to predict the outcome of the Ames mutagenicity assayMarch 2015pdf fileDerek NexusSarah Nexus
Building models of bacterial mutagenicity from biased training data.pdfMarch 2015pdf fileSarah Nexus
Computational Approaches to Managing Mutagenicity Risk for ICH M7 and Beyond.pdfMarch 2015pdf fileDerek NexusMirabilisSarah NexusVitic NexusZeneth
ICH M7 - Have you got it covered?March 2015Derek NexusMirabilisSarah NexusVitic NexusZeneth
(Q)SAR assessments of potentially mutagenic impurities: A regulatory perspective on the utility of expert knowledge and data submissionMarch 2015
Importance of Comprehensive Reporting of (Q)SAR Assessments Under ICH M7.pdfMarch 2015pdf file
The FDA CDER Chemical Informatics Program .pdfMarch 2015pdf file
Living with M7.pdfMarch 2015pdf fileDerek NexusSarah Nexus
Nexus 2 - Improved functionality to assist in ICH M7 submissionDecember 2014Derek NexusSarah Nexus
Progress on Building a Tool for Predicting the Purging of Mutagenic Impurities During Synthesis.pdfNovember 2014pdf fileMirabilis
Building Models within Sarah Nexus.pdfSeptember 2014pdf fileSarah Nexus
Derek Nexus and Sarah Nexus - working together for ICH M7.pdfSeptember 2014pdf fileDerek NexusSarah Nexus
Explaining and demonstrating successful use of purging and depletion strategies to control mutagenic impuritiesSeptember 2014pdf fileMirabilis
38th ICGM Product Update.pdfSeptember 2014pdf fileDerek NexusMeteor NexusSarah NexusVitic NexusZeneth
Progress on Building a Tool for Predicting the Purging of Mutagenic Impurities During Synthesis.pdfSeptember 2014pdf fileMirabilis
Explaining and demonstrating successful use of purging and depletion strategies to control mutagenic impurities.pdfSeptember 2014pdf fileMirabilis
An update on the GTI Purge Tool ProjectAugust 2014pdf fileMirabilis
A Collaborative Approach towards Risk Assessment for Mutagenic Impurities.pdfJuly 2014pdf fileMirabilis
FDA/CDER Current Practices for (Q)SAR Analysis under ICH M7.pdfApril 2014pdf file
Reconciling Conflicting (Q)SAR Predictions in Impurity Evaluations.pdfApril 2014pdf file
Benchmarking Assessment of Salmonella Mutagenicity QSAR Models for Potential Use Under ICH M7.pdfMarch 2014pdf fileSarah Nexus
Establishing best practice for the application of a novel statistical-model to evaluate potential mutagenic impurities under ICH M7March 2014pdf fileSarah Nexus
ICH M7 How Lhasa can support you.pdfMarch 2014pdf fileDerek Nexus
Lilly - An Evaluation of in silico Mutagenicity Models for ICH M7 Draft Guidance.pdfMarch 2014pdf fileDerek NexusVitic Nexus
The use of integrated in silico solutions under the proposed ICH M7 guidelines final.pdfMarch 2014pdf fileDerek NexusSarah Nexus
Supporting members with the emerging ICH M7 guidelines.pdfDecember 2013pdf fileDerek NexusSarah NexusVitic NexusZeneth
Application and Development of Negative Predictions in Derek.pdfNovember 2013pdf fileDerek Nexus
Use of in silico systems and expert knowledge for structure-based assessment of potentially mutagenic impuritiesOctober 2013Derek Nexus
Comparative Evaluation of in Silico Systems for Ames Test Mutagenicity Predict.pdfSeptember 2013pdf fileDerek NexusSarah Nexus
An Expert System To Predict the Forced Degradation of Organic MoleculesJuly 2013Zeneth
Use of Multiple Systems for Mutagenicity Prediction.wmvJune 2013Derek NexusSarah Nexus
Giving Confidence for in silico GTI Assessment.pdfJune 2013pdf fileDerek Nexus
Collaborative Solutions to ICH M7.pdfJune 2013pdf fileDerek NexusSarah NexusVitic NexusZeneth
Derek - predicting mutagenicity and the ICH M7 guidelines.pdfApril 2013pdf fileDerek Nexus
Strengthening the Case for in silico GTI Assessments.pdfMarch 2013pdf fileDerek NexusSarah Nexus
2012 virtual ICGM 8 Sarah.pdfNovember 2012pdf fileSarah Nexus
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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