Pharmaceutical
Related Publications
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- 2012 virtual ICGM1 - Vitic Excipients.pdf
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- A Collaborative Approach towards Risk Assessment for Mutagenic Impurities.pdf
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- A knowledge-based approach to the in silico assessment of toxicity .pdf
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- Analysis of human and in vivo data for hepatotoxicity modelling
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- Biotransformation Pathways of Biocides and Pharmaceuticals in Freshwater Crustaceans
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- Comparative Evaluation of in Silico Systems for Ames Test Mutagenicity Predict.pdf
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- Nexus 2 - Improved functionality to assist in ICH M7 submission
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- Relationship between the mutagenicity of arylboronic acids and 11B NMR chemical shifts
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- Building models of bacterial mutagenicity from biased training data.pdf
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- Explaining and demonstrating successful use of purging and depletion strategies to control mutagenic impurities
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- Living with M7.pdf
- Lhasa ICH M7 database
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- ICH M7 Workflow.pdf
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- Practical examples of the new metabolism ranking system in Meteor Nexus.pdf
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- 43rd ICGM Product Update
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- Improvements to in silico predictivity after access to proprietary data
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- Elemental impurities in excipients: a pre-competitive data sharing initiative to support risk assessment under ICH Q3D.
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- A tool for predicting the purging of (potentially) mutagenic impurities during synthesis
- ICH M7 - Worked Examples using the new Nexus workflow
- Skin sensitisation: Now and the Future
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- An Automated Classification Workflow to Assist Expert Assessment and Regulatory Submission for ICH M7
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- Skin Sensitisation - Negative Predictions, Validations and Integrated Testing Strategies
- Assessing confidence in predictions made by knowledge-based systems
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- Mechanistic Expert Call Datasets Provide In Silico Prediction of Teratogenicity for a Wider Chemical Space
- Utilization Of Derek Nexus Dermal Sensitization Predictions For Hazard Assessment At Bristol-Myers Squibb
- ICH M7 Classification Workflow
- Quantitative prediction of skin sensitisation potency based on structural alert spaces
- Performance of Derek Nexus’ In Silico EC3 Model for Predicting Dermal Sensitization Potency
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- Workbook: Expert Review of EC3 Predictions - a workshop
- A quantitative in silico model for predicting skin sensitization using a nearest neighbours approach within expert-derived structure–activity alert spaces
- Phosphite esters: a novel class of contact allergen
- Nothing to report? An in silico fragmentation methodology for making explicit negative predictions of skin sensitisation
- Extrapolation of in vitro mutagenicity alerts to the in vivo endpoint in Derek Nexus
- Getting under the skin of an in silico approach to predicting dermal sensitisation
- Using Sarah Nexus Effectively: Intuitive Model Building and Interpreting Confidence
- Alternatives to in vivo testing for plant protection products
- Integrated hazard identification of chemical sensitizers using in vitro and in silico readouts - A comparative evaluation of predictive performance
- Negative Predictions for Skin Sensitisation 47th ICGM
- Manual and Computational Methods for the Evaluation of Statistical Predictions Based on Expert Analysis
- In silico prediction of the skin sensitisation potential of non-quinonoid Michael acceptors: new reactivity assessments and evidence based precursor selection
- Sarah Nexus: The Statistical System for ICH M7
- An Overview of Lhasa Limited Collaborative Data Sharing Initiatives
- iPiE: Intelligence-led Assessment of Pharmaceuticals in the Environment
- 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
- Observations on the Pharma's Industry Convergence toward Cloud
- 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
- Setaria 1.2 Installation Guide
- 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
- A Defined Approach to Skin Sensitization Using Derek Nexus and Non-Animal Assays
- 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
- Plans for Setaria - Incorporating Setaria into the Pfizer Workflow
- 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?
- Using New Features to Further Interrogate Sarah Nexus Predictions
- A Defined Approach to Skin Sensitisation: Integrating Derek Nexus with In Chemico/In Vitro Assays - A Summary
- Derek Nexus and the Prediction of Human Skin Sensitisation Potential - 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
- How Zeneth fits into ICH Q3D
- 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
- Use of In Silico for Assessing Degradants
- Toxicity Studies for Degradation Impurities - An Industry Perspective
- 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
- Developing an adverse outcome pathway framework for carcinogenicity from alerts in an expert rule-based system
- 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 to Skin Sensitisation: Integrating Derek Nexus with In Chemico/In Vitro Assays Based on Exclusion Criteria
- Zeneth: an in silico tool to aid identification of degradants
- A Defined Approach for Predicting Skin Sensitisation Hazard and Potency
- Enhancing the ICH M7 Workflow through Setaria
- A consortium-driven framework to guide the implementation of ICH M7 Option 4 control strategies
- Setaria 2.0 Installation Guide
- 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
- A defined approach for predicting skin sensitisation hazard and potency based on the guided integration of in silico, in chemico and in vitro data using exclusion criteria
- Skin Sensitisation Brochure
- The Liability Load and how Lhasa Limited Focuses on Reducing it
- How To - Filtering Mass Defect
- How low can you go? An analysis of lowest effective dose in the Ames test.
- Improving In Silico Predictions in Developmental and Reproductive Toxicology
- A Suggested ICH M7 Framework Using Lhasa Limited Products
- Setaria 3.0 Installation Guide
- ICHQ3D Implementation: Use of published data driven risk assessments
- RDC53: Challenges on impurities qualification
- Draft Reflection Paper - Non-Genotoxic Impurities
- Q3D Regulatory Case Study
- In silico prediction of Mutagenicity
- Toxicity Evaluation of Degradation Products
- 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 2
- 2019 Pharmaceutical Industry and Regulators Symposium Recording - Day 1, Part 3
- 2019 Pharmaceutical Industry and Regulators Symposium Recording - Day 1, Part 1
- 2019 Pharmaceutical Industry and Regulators Symposium Recording - Day 1, Part 4
- Save Time and Money with Lhasa Limited
