Regulators
Related Publications
- A Collaborative Approach towards Risk Assessment for Mutagenic Impurities.pdf
- A practical application of two in silico systems for identification of potentially mutagenic impurities
- A rationale for determining, testing, and controlling specific impurities in pharmaceuticals that possess potential for genotoxicity
- Adding In Vivo Mammalian Cytogenetics Data to SEND and ToxML.pdf
- Addressing toxicity risk when designing and selecting compounds in early drug discovery
- An evaluation of in-house and off-the-shelf in silico models: Implications on guidance for mutagenicity assessment
- An Expert System To Predict the Forced Degradation of Organic Molecules
- An in Silico Method for Predicting Ames Activities of Primary Aromatic Amines
- Analysis of human and in vivo data for hepatotoxicity modelling
- Assessing Confidence in Predictions.wmv
- Biotransformation Pathways of Biocides and Pharmaceuticals in Freshwater Crustaceans
- Developing Structure-Activity Relationships for the Prediction of Hepatotoxicity
- An update on the GTI Purge Tool Project
- Expert Systems - The Use of Expert Systems in Drug Design-Toxicity and Metabolism
- Explaining and demonstrating successful use of purging and depletion strategies to control mutagenic impurities.pdf
- FDA/CDER Current Practices for (Q)SAR Analysis under ICH M7.pdf
- Food for thought - A toxicology ontology roadmap
- ICH M7 - Have you got it covered?
- Lilly - An Evaluation of in silico Mutagenicity Models for ICH M7 Draft Guidance.pdf
- Nexus 2 - Improved functionality to assist in ICH M7 submission
- Derek Nexus in early discovery
- Derek - predicting mutagenicity and the ICH M7 guidelines.pdf
- Evaluation Of A Statistics-based Ames Mutagenicity QSAR Model And Interpretation Of The Results Obtained
- It’s difficult, but important, to make negative predictions
- Predicting skin sensitisation using a decision tree integrated testing strategy with an in silico model and in chemico/in vitro assays
- Mutagenicity assessment strategy for pharmaceutical intermediates to aid limit setting for occupational exposure
- (Q)SAR assessments of potentially mutagenic impurities: A regulatory perspective on the utility of expert knowledge and data submission
- 38th ICGM Product Update.pdf
- 42nd ICGM Product Update.pdf
- Benchmarking Assessment of Salmonella Mutagenicity QSAR Models for Potential Use Under ICH M7.pdf
- Establishing best practice for the application of a novel statistical-model to evaluate potential mutagenic impurities under ICH M7
- Can public data improve mutagenicity predictions for proprietary compounds.pdf
- The use of integrated in silico solutions under the proposed ICH M7 guidelines final.pdf
- Building models of bacterial mutagenicity from biased training data.pdf
- Analysis of human and in vivo data for hepatotoxicity modelling.pdf
- Computational Approaches to Managing Mutagenicity Risk for ICH M7 and Beyond.pdf
- ICH M7 How Lhasa can support you.pdf
- Building Models within Sarah Nexus.pdf
- Derek Nexus and Sarah Nexus - working together for ICH M7.pdf
- Explaining and demonstrating successful use of purging and depletion strategies to control mutagenic impurities
- Progress on Building a Tool for Predicting the Purging of Mutagenic Impurities During Synthesis.pdf
- Living with M7.pdf
- Improving xenobiotic metabolite ranking
- Mirabilis: a tool for predicting the purging of mutagenic impurities during synthesis
- Why data sharing is important - a case study using proprietary mutagenicity and skin sensitisation data.pdf
- Undertaking Expert Review under ICH M7 - A Practical Guide
- 43rd ICGM Product Update
- Using Data to make Predictions in the Risk Assessment of Mutagenic Impurities
- Mutagenic impurities: predicting alerting structures using in silico tools
- Structure Guided Design and Optimization of Selective Kinase Inhibitors from Fragment Starting Points
- Practical Implementation of (Q)SAR and Expert Review for Compliance with ICH M7 Guidelines
- Guiding Compound Design in 2,3...N Dimensions
- Predicting the Purging of Impurities within an API Synthetic Pathway
- Speeding up and improving the Identification of a potent ß2 agonist as a growth promoter for cattle
- Improvements to in silico predictivity after access to proprietary data
- Summation of Toxicity Data in Vitic
- Using In Silico Software to Generate an ICH M7 Submission and Expert Review
- A tool for predicting the purging of (potentially) mutagenic impurities during synthesis
- ICH M7 - Worked Examples using the new Nexus workflow
- Refining the prediction of skin sensitisation potential: performance of the Derek Nexus knowledge base for a published dataset
- Skin Sensitisation - Negative Predictions, Validations and Integrated Testing Strategies
- Assessing confidence in predictions made by knowledge-based systems
- ICH M7 Classification Workflow
- Workbook: Expert Review of EC3 Predictions - a workshop
- Nothing to report? An in silico fragmentation methodology for making explicit negative predictions of skin sensitisation
- Using Sarah Nexus Effectively: Intuitive Model Building and Interpreting Confidence
- Alternatives to in vivo testing for plant protection products
- Negative Predictions for Skin Sensitisation 47th ICGM
- Manual and Computational Methods for the Evaluation of Statistical Predictions Based on Expert Analysis
- Sarah Nexus: The Statistical System for ICH M7
- An Overview of Lhasa Limited Collaborative Data Sharing Initiatives
- Negative Predictions for Skin Sensitisation
- Expert Review of EC3 Predictions
- Lhasa Data Sharing Experience at Bristol-Myers Squibb
- Expert Review of In Silico Predictions for Skin Sensitization Potency
- Drug Master File (DMF) Holders Preferred PGI Control Strategy Under ICH M7 in Support of Abbreviated New Drug Applications (ANDAs)
- Nexus 2.2: An Overview of Key New Features - Sarah Nexus
- Nexus 2.2: An Overview of Key New Features - Derek and Meteor Nexus
- EC3: Methodology Explained
- Potential impurities in drug substances: Compound-specific toxicology limits for 20 synthetic reagents and by-products, and a class-specific toxicology limit for alkyl bromides
- Strain profiles: Moving beyond binary Ames classification
- Addressing the Challenge of Making Negative Predictions for Skin Sensitisation
- Derek Nexus and the Prediction of Human Skin Sensitisation Potential: An Evaluation
- Sarah Nexus Strain Information
- In Silico Prediction of DILI - Extraction of Histopathology Data from Preclinical Toxicity Data Studies of the eTOX Database for new In SIlico Models of Hepatotoxicity
- Skin sensitisation - What place does in silico have within a defined approach?
- A Defined Approach to Skin Sensitisation: Integrating Derek Nexus with In Chemico/In Vitro Assays - A Summary
- Strain Profiles: Moving Beyond Binary Ames Classification - A Summary
- Addressing the Challenge of Making Negative Predictions for Skin Sensitisation - A Summary
- An Elemental Impurities Excipient Database: A Viable Tool for ICH Q3D Drug Product Risk Assessment
- ICH M7 Overview: Predicting, Assessing, and Controlling Mutagenic Impurities from Degradation
- ICH M7 Use Cases
- Improving Toxicity Predictions through knowledge and data sharing
- Perspectivas Regulatórias sobre a Qualificação de Produtos de Degradação e Impurezas
- Supporting Lhasa Members in a Regulatory Setting
- Mutagenicity Predictions using a Statistical System
- Mirabilis: Using Mirabilis to Support Purge Arguments Under ICH M7
- CIGAA - Consortium for the Investigation of Genotoxicity of Aromatic Amines.pdf
- Making reliable negative predictions of human skin sensitisation using an in silico fragmentation approach
- Vitic - A Faster, More Efficient Searching Experience
- A pharma-wide approach to address the genotoxicity prediction of primary aromatic amines.
- Interpreting the Sensitivity and Equivocal Settings in Sarah Nexus
- Elemental Impurities Data Sharing Initiative
- A Defined Approach for Predicting Skin Sensitisation Hazard and Potency
- Enhancing the ICH M7 Workflow through Setaria
- Principles and procedures for handling out-of-domain and indeterminate results as part of ICH M7 recommended (Q)SAR analyses
- Important considerations for the validation of QSAR models for in vitro mutagenicity
- The Liability Load and how Lhasa Limited Focuses on Reducing it
- How To - Filtering Mass Defect
- Improving In Silico Predictions in Developmental and Reproductive Toxicology
- A Suggested ICH M7 Framework Using Lhasa Limited Products
- ICHQ3D Implementation: Use of published data driven risk assessments
- Draft Reflection Paper - Non-Genotoxic Impurities
- Q3D Regulatory Case Study
- In silico prediction of Mutagenicity
- Valsartan – Implications
- Managing Mutagenic Impurity Risks in Pharmaceutical Products
- (Q)SAR Evaluation of Drug Impurities from the US FDA Scientific Perspective
- Setting the basis for the mutagenicity assessment of new dyes: Application to the Max Weaver Dye Library
- 2019 Pharmaceutical Industry and Regulators Symposium Recording - Day 1, Part 1
- 2019 Pharmaceutical Industry and Regulators Symposium Recording - Day 1, Part 2
- 2019 Pharmaceutical Industry and Regulators Symposium Recording - Day 1, Part 3
- 2019 Pharmaceutical Industry and Regulators Symposium Recording - Day 1, Part 4
- 2019 Pharmaceutical Industry and Regulators Symposium Recording - Day 2, Part 1
- 2019 Pharmaceutical Industry and Regulators Symposium Recording - Day 2, Part 2
- 2019 Pharmaceutical Industry and Regulators Symposium Recording - Day 2, Part 3
- 2019 Pharmaceutical Industry and Regulators Symposium Recording - Day 2, Part 4
- ICH M7 - Risk assessment for mutagenic impurities and control strategies
- Zeneth: an in silico tool to aid identification of degradants
- How Zeneth fits into ICH Q3D
- Use of In Silico for Assessing Degradants
- Toxicity Evaluation of Degradation Products
- RDC53: Challenges on impurities qualification
- Toxicity Studies for Degradation Impurities - An Industry Perspective
- Current advances in skin sensitization in silico predictions and their use in a defined approach
- 2020 Zeneth 8 Webinar Recording
