Lhasa Limited shared knowledge shared progress

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
How to resolve inconclusive predictions from defined approaches for skin sensitisation in OECD Guideline No. 497August 2022Derek Nexus
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
Collaborative analysis of complex nitrosaminesApril 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
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

© 2022 Lhasa Limited | Registered office: Granary Wharf House, 2 Canal Wharf, Leeds, LS11 5PS, UK Tel: +44 (0)113 394 6020
VAT number 396 8737 77 | Lhasa Limited is registered as a charity (290866)| Company Registration Number 01765239 (England and Wales).

Apart from the free survey software, we also have access to QuestionPro's free survey templates . We've found many of them useful and powerful to collect insights from various stakeholders of our organization.