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Regulators Publications

The following links provide access to relevant Regulators 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
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
In Silico Prediction of Genotoxicity Current Applications and Future PerspectivesSeptember 2021pdf fileDerek NexusSarah 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
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
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
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
Bringing Together Scientific Disciplines for Collaborative Undertakings: A Vision for Advancing the Adverse Outcome Pathway FrameworkFebruary 2021pdf file
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
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
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 - 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 1 - Creating a DART AOP network to enable improved decision-making during risk assessments - RecordingOctober 2020
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
Use of Mirabilis based purge calculations to understand Nitrosamine-related risk and control strategy optionsJuly 2020Mirabilis
The Application of Adverse Outcome Pathways (AOPs) for Risk AssessmentMay 2020pdf file
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
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
Utilising Adverse Outcome Pathways as a Framework to Organise Evidence and Support Carcinogenicity Risk AssessmentMarch 2020pdf file
Predicting the safety of medicines in pregnancy: A workshop reportMarch 2020
2019 Webinar Zeneth 8: A faster, more intuitive, degradation predictive system - RecordingNovember 2019Zeneth

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