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Pharmaceutical Publications

The following links provide access to relevant Pharmaceutical 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
Nitrosamine Reactivity: A Survey of Reactions and Purge ProcessesNovember 2021Mirabilis
Developing structure-activity relationships for N-nitrosamine activityNovember 2021Derek Nexus
Supporting more scientifically driven risk assessments under ICH Q3DNovember 2021pdf file
Introduction to ICH Q3D guidance_The move from heavy metal testing to ICH Q3DNovember 2021pdf file
Supporting more scientifically driven risk assessments under ICH Q3D: Elemental Impurities Data Sharing_Webinar RecordingNovember 2021
ICH Q3D Drug Product Elemental Risk Assessment: The use of an elemental impurities excipients databaseOctober 2021
Structural features affecting nitrosamine carcinogenic potencySeptember 2021pdf file
In Silico Prediction of Genotoxicity Current Applications and Future PerspectivesSeptember 2021pdf fileDerek NexusSarah Nexus
Resolving conflicting data sources to a single call in Sarah Nexus [an infographic]September 2021pdf fileSarah Nexus
Zeneth Member Type InfographicAugust 2021pdf fileZeneth
2021 Webinar | Accessing vital sources of long-term carcinogenicity study data with Lhasa’s Carcinogenicity Database – An update and an overview - RecordingJuly 2021
2021 Webinar | Accessing vital sources of long-term carcinogenicity study data with Lhasa’s Carcinogenicity Database – An update and an overview - SlidesJuly 2021pdf file
QSAR 2021 Addressing the global challenge of N-nitrosamine impurity assessmentJune 2021pdf fileDerek NexusMirabilisSarah NexusVitic Nexus
QSAR 2021 - leveraging data from multiple sources to build QSARs through curation and federated learning in Effiris.June 2021pdf file
QSAR 2021 Is the bacterial reverse mutation assay an accurate predictor for N-nitrosamine carcinogenicityJune 2021pdf fileVitic Nexus
Predicting N-Nitrosamine Activity from SARJune 2021pdf fileDerek NexusSarah Nexus
Effiris_Improving in silico secondary pharmacology profiling using federated QSAR modelsJune 2021pdf file
Managing the risk of nitrosamine impuritiesJune 2021
Quantifying the nitrosamine potency distributionMay 2021pdf file
A collaborative benchmarking study to evaluate the newly released Zeneth 8May 2021pdf fileZeneth
In silico prediction of N-nitrosamine degradants in APIs that possess a secondary or tertiary amine functional groupMay 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
Data Sharing Projects using Vitic [an infographic]April 2021pdf fileExcipientsIntermediatesVitic Nexus
Development of an Adverse Outcome Pathway Network to Support an Integrated Approach to Testing and Assessment of Carcinogenic Risk - SOT 2021 Presentation SlidesMarch 2021pdf fileDerek Nexus
Systematic analysis of protein targets associated with adverse events of drugs from clinical trials and postmarketing reportsMarch 2021
The eTRANSAFE Project on Translational Safety Assessment through Integrative Knowledge Management: Achievements and PerspectivesMarch 2021
Case study on the use of integrated approaches to testing and assessment for the prediction of a 90-day repeated dose toxicity study (OECD 408) for 2-Ethylbutyric acid using a read-across approach from other branched carboxylic acids.March 2021
Guidelines for FAIR sharing of preclinical safety and off-target pharmacology dataMarch 2021
2021 Webinar - An overview of Effiris 2.1; An enhanced qualitative model suite for anticipating and mitigating adverse drug reactions – Slides and recordingFebruary 2021pdf file
Utilisation of parametric methods to improve percentile-based estimates for the carcinogenic potency of nitrosaminesFebruary 2021
Deriving compound-specific exposure limits for chemicals used in pharmaceutical synthesis: Challenges in expert decision-making exemplified through a case study-based workshopFebruary 2021
Beyond adverse outcome pathways: making toxicity predictions from event networks, SAR models, data and knowledgeJanuary 2021
Nexus ICH M7 Expert Review Support Functionality (an infographic)December 2020pdf fileDerek NexusSarah Nexus
Development of an Adverse Outcome Pathway Network to Support an Integrated Approach to Testing and Assessment of Carcinogenic RiskDecember 2020pdf file
HuskinDB, a database for skin permeation of xenobioticsDecember 2020
2020 AI/PDE Webinar -Acceptable Intake (AI) and Permitted Daily Exposure (PDE) data sharing project for pharmaceutical impurities - SlidesDecember 2020pdf file
2020 AI/PDE Webinar -Acceptable Intake (AI) and Permitted Daily Exposure (PDE) data sharing project for pharmaceutical impurities - RecordingDecember 2020
Application of adverse outcome pathways (AOPs) to support genotoxicity assessmentNovember 2020pdf file
2020 Zeneth 8 webinar - Zeneth 8: A re-designed and improved forced degradation prediction system for organic compounds - RecordingNovember 2020Zeneth
2020 Zeneth 8 webinar - Zeneth 8: A re-designed and improved forced degradation prediction system for organic compounds - SlidesNovember 2020pdf fileZeneth
Management of pharmaceutical ICH M7 (Q)SAR predictions – The impact of model updatesNovember 2020Derek NexusSarah NexusVitic Nexus
Anticipating and mitigating adverse drug reactions through machine learning and privacy-preserving data sharing (infographic)November 2020pdf file
Machine Learning Predicts Degree of Aromaticity from Structural FingerprintsNovember 2020
Session 4 - The growing network of genotoxicity AOPs - RecordingOctober 2020
Session 4 - The growing network of genotoxicityAOPs - SlidesOctober 2020pdf file
Session 4 - Combining knowledge and data on an AOP framework in order to take advantage of new and emerging methods In genotoxicity assessment - SlidesOctober 2020pdf file
Session 4 - Combining knowledge and data on an AOP framework in order to take advantage of new and emerging methods In genotoxicity assessment - RecordingOctober 2020
Session 3 - Exploiting AOPs as a framework to support ICH S1 risk assessments - SlidesOctober 2020pdf file
Session 3 - Exploiting AOPs as a framework to support ICH S1 risk assessments - RecordingOctober 2020
Session 3 - A pharmaceutical regulator’s view on the utility of adverse outcome pathways for carcinogenicity assessment - SlidesOctober 2020pdf file
Session 3 - A pharmaceutical regulator’s view on the utility of adverse outcome pathways for carcinogenicity assessment - RecordingOctober 2020
Session 2 - Integration of adverse outcome pathways with experimental data to support the assessment of carcinogenic risk - SlidesOctober 2020pdf file
Session 2 - Integration of adverse outcome pathways with experimental data to support the assessment of carcinogenic risk - RecordingOctober 2020
Session 2 - AOP and IATA complimentary frameworks to modernize chemical risk assessment - SlidesOctober 2020pdf file
Session 2 - AOP and IATA complimentary frameworks to modernize chemical risk assessment - RecordingOctober 2020
Could purge calculations support your regulatory submissions? (Infographic)October 2020pdf fileMirabilis
Session 1 - Creating a DART AOP network to enable improved decision-making during risk assessments - RecordingOctober 2020
Session 1 - Creating a DART AOP network to enable improved decision-making during risk assessments - SlidesOctober 2020pdf file
Session 1 - Building quantitative AOPs of the DARTable genome to explore risks of developmental toxicity - SlidesOctober 2020pdf file
Session 1 - Building quantitative AOPs of the DARTable genome to explore risks of developmental toxicity - RecordingOctober 2020
Developing Federated QSAR Models for Secondary PharmacologySeptember 2020pdf file
Integrating Knowledge Of Carcinogenicity Adverse Outcome Pathways (AOPs) With Experimental Data_EMGS Data Challenge 2020September 2020pdf fileDerek NexusVitic Nexus
Introducing the concept of virtual control groups into preclinical toxicology testingSeptember 2020ETOX
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
Are all nitrosamines concerning? A review of mutagenicity and carcinogenicity dataSeptember 2020Derek NexusSarah NexusVitic Nexus
Pathways for N-nitroso compound formation: secondary amines and beyondJuly 2020
Do all nitrosamines pose a significant level of genotoxic risk? (Webinar Presentation Slides)July 2020pdf fileDerek NexusSarah Nexus
Controlling a cohort - Understanding the risk of nitrosamines within drug substance synthesis (Webinar Presentation Slides)July 2020Mirabilis
ICH M7 Workshop Japanese ICGM 2019July 2020pdf fileSetariaSarah NexusMirabilisVitic NexusDerek Nexus
Use of Mirabilis based purge calculations to understand Nitrosamine-related risk and control strategy optionsJuly 2020Mirabilis
Evaluation of the Global Performance of Eight In Silico Skin Sensitization Models Using Human DataMay 2020Derek Nexus
Building Secondary Pharmacology Models: A Novel Approach to Proprietary Data Transfer.May 2020pdf file
Building Secondary Pharmacology Models: A Novel Approach to Proprietary Data Transfer - RecordingMay 2020
The Application of Adverse Outcome Pathways (AOPs) for Risk AssessmentMay 2020pdf file
Mirabilis Cost Saving InfographicApril 2020pdf fileMirabilis
Vitic Data Sharing BenefitsApril 2020pdf fileVitic Nexus
Who is using Vitic? InfographicApril 2020pdf fileVitic Nexus
Lhasa's Carcinogenicity Database - RecordingApril 2020
Introduction to the Lhasa Carcinogenicity Database - RecordingApril 2020
Accessing Carcinogenicity Potency DataApril 2020pdf file
Introduction to the Lhasa Carcinogenicity DatabaseApril 2020pdf file
Mirabilis Purge Ratio InfographicMarch 2020pdf fileMirabilis
Aiding and standardising expert review under ICH M7March 2020pdf file
In silico workflow under ICH M7March 2020pdf fileDerek NexusSetariaVitic NexusSarah Nexus
Aiding and standardising expert review under ICH M7 - RecordingMarch 2020
In silico workflow under ICH M7 - RecordingMarch 2020
Comparing and combining in silico outcomes and in vitro mechanism-based assays to predict genotoxicityMarch 2020pdf fileDerek NexusVitic Nexus
Updated Dermal Sensitisation Thresholds derived using an in silico expert system and an expanded Local Lymph Node Assay datasetMarch 2020pdf fileDerek NexusVitic Nexus
Utilising Adverse Outcome Pathways as a Framework to Organise Evidence and Support Carcinogenicity Risk AssessmentMarch 2020pdf file
Are All Nitrosamines Concerning?March 2020pdf fileVitic Nexus
Setaria - Managing Predictions, Data and Expert Review under ICH M7March 2020pdf fileSetaria
Predicting the safety of medicines in pregnancy: A workshop reportMarch 2020
ICH M7 Workshop - 2020 ICH M7 India RoadshowsMarch 2020pdf fileDerek NexusSarah NexusZenethVitic NexusSetariaMirabilis
Predictions, Data and ICH M7 - 2020 ICH M7 India RoadshowsMarch 2020pdf fileDerek NexusSarah NexusVitic NexusSetaria
Lhasa and the ICH M7 Guideline - 2020 ICH M7 India RoadshowMarch 2020pdf fileDerek NexusSarah NexusVitic NexusSetariaMirabilis
GSK MI risk assessment process Camicinal at al - 2020 ICH M7 India RoadshowMarch 2020pdf fileDerek NexusSarah NexusVitic Nexus
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
Quantitative Analysis of In Vivo Dose-Response Data for Risk Assessment and Regulatory Decision Making - RecordingJanuary 2020
Approaches to Skin Sensitisation PredictionNovember 2019pdf fileDerek Nexus
Mirabilis - Case Study of a Risk Assessment for ICH M7 Control of ImpuritiesNovember 2019pdf fileMirabilis
2019 Webinar Zeneth 8: A faster, more intuitive, degradation predictive system - RecordingNovember 2019Zeneth
2019 Webinar Zeneth 8: A faster, more intuitive, degradation predictive system - SlidesNovember 2019pdf fileZeneth

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