Regulators
Related Publications
- A practical application of two in silico systems for identification of potentially mutagenic impurities
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- Addressing toxicity risk when designing and selecting compounds in early drug discovery
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- An Expert System To Predict the Forced Degradation of Organic Molecules
- An in Silico Method for Predicting Ames Activities of Primary Aromatic Amines
- Assessing Confidence in Predictions.wmv
- Biotransformation Pathways of Biocides and Pharmaceuticals in Freshwater Crustaceans
- Developing Structure-Activity Relationships for the Prediction of Hepatotoxicity
- Expert Systems - The Use of Expert Systems in Drug Design-Toxicity and Metabolism
- Food for thought - A toxicology ontology roadmap
- Nexus 2 - Improved functionality to assist in ICH M7 submission
- Evaluation Of A Statistics-based Ames Mutagenicity QSAR Model And Interpretation Of The Results Obtained
- It’s difficult, but important, to make negative predictions
- Benchmarking Assessment of Salmonella Mutagenicity QSAR Models for Potential Use Under ICH M7.pdf
- 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
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- Structure Guided Design and Optimization of Selective Kinase Inhibitors from Fragment Starting Points
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- 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
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- Refining the prediction of skin sensitisation potential: performance of the Derek Nexus knowledge base for a published dataset
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- ICH M7 Classification Workflow
- Workbook: Expert Review of EC3 Predictions - a workshop
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- Nexus 2.2: An Overview of Key New Features - Sarah Nexus
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- EC3: Methodology Explained
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- Sarah Nexus Strain Information
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- ICH M7 Use Cases
- Improving Toxicity Predictions through knowledge and data sharing
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- Supporting Lhasa Members in a Regulatory Setting
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- 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
- Mutagenicity assessment strategy for pharmaceutical intermediates to aid limit setting for occupational exposure
- Predicting skin sensitisation using a decision tree integrated testing strategy with an in silico model and in chemico/in vitro assays
- Utilising Adverse Outcome Pathways as a Framework to Organise Evidence and Support Carcinogenicity Risk Assessment
- Predicting the safety of medicines in pregnancy: A workshop report
- Comparing and combining in silico outcomes and in vitro mechanism-based assays to predict genotoxicity
- In silico workflow under ICH M7 - Recording
- Aiding and standardising expert review under ICH M7 - Recording
- In silico workflow under ICH M7
- Introduction to the Lhasa Carcinogenicity Database - Recording
- Lhasa's Carcinogenicity Database - Recording
- Who is using Vitic? Infographic
- Vitic Data Sharing Benefits
- Aiding and standardising expert review under ICH M7
- The Application of Adverse Outcome Pathways (AOPs) for Risk Assessment
