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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
Use of the bacterial reverse mutation assay to predict carcinogenicity of N-nitrosaminesSeptember 2022Derek NexusSarah Nexus
How to resolve inconclusive predictions from defined approaches for skin sensitisation in OECD Guideline No. 497August 2022Derek Nexus
Letter to the editor of Heliyon re: determination of dimethylamine and nitrite in pharmaceuticals by ion chromatography to assess the likelihood of nitrosamine formationJuly 2022
Data Dos and Don’ts In Building Statistical Models For Ames MutagenicityJune 2022pdf fileSarah Nexus
eTRANSAFE: Building a sustainable framework to share reproducible drug safety knowledge with the public domainJune 2022
Development of a network of carcinogenicity adverse outcome pathways and its employment as an evidence framework for safety assessmentJune 2022
A Nitrite Excipient Database: A Useful Tool to Support N-Nitrosamine Risk Assessments for Drug ProductsMay 2022
An Evaluation of the Occupational Health Hazards of Peptide CouplersMay 2022Derek Nexus
Application of AOPs for Weight-of-Evidence Assessments: Rationalising Evidence for the ICH S1B(R1) Guidance AddendumApril 2022pdf file
Assessment of the dermal sensitisation potency of extractables and leachables using existing data and in silico methodsApril 2022pdf fileVitic NexusDerek Nexus
Collaborative analysis of complex nitrosaminesApril 2022pdf file
The Role of Expert Assessment and In Silico Predictions in Determining Genotoxic Risk of N-Nitrosamine ImpuritiesApril 2022pdf file
Updated Dermal Sensitisation Thresholds derived using an in silico expert system and an expanded Local Lymph Node Assay datasetApril 2022pdf fileDerek Nexus
Using Data Associated with a Developmental and Reproductive Toxicity Adverse Outcome Network to Aid Safety AssessmentsApril 2022pdf file
Using privacy-preserving federated learning to enable pre-competitive cross-industry knowledge sharing and improve QSAR modelsApril 2022pdf file
Interrogating AOP-Wiki knowledge as a networkApril 2022pdf file
How Well Do Defined Approaches Predict the Human Skin Sensitisation Potential of Previously Untested Chemicals?April 2022
Using adverse outcome pathways to contextualise (Q)SAR predictions for reproductive toxicity – A case study with aromatase inhibitionFebruary 2022
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

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