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Publications

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Publication Type

Date

Paper

Industrial Case Studies Demonstrating Applicability of ICH M7 Control Options 3 and 4 for Nitrosamine Control

  • Mar 2025
  • Impurity and degradant control, Nitrosamine impurity risk assessment

Paper

Data-driven federated learning in drug discovery with knowledge distillation

  • Mar 2025
  • Safety profiling in drug discovery

Paper

Comprehensive Extractables and Leachables Sensitization Analysis and Practical Application of a Risk-Based Approach to Sensitization Assessment for Parenteral Drug Products

  • Feb 2025
  • Skin sensitisation assessment

Paper

Critical comparison of BMD and TD50 methods for the calculation of acceptable intakes for N-nitroso compounds

  • Jan 2025
  • Carcinogenicity assessment

Paper

Control of N-nitrosamine impurities in drug products: Progressing the current CPCA framework and supporting the derivation of robust compound specific Acceptable Intakes

  • Dec 2024
  • Nitrosamine impurity risk assessment

Infographic

Accelerating safety assessments for carcinogenicity with Kaptis

  • Oct 2024
  • Carcinogenicity assessment

Paper

Industrial Genotoxicology Group (IGG): 36th Annual Meeting Report

  • Oct 2024
  • Nitrosamine impurity risk assessment

Paper

Reactivities of N-Nitrosamines against Common Reagents and Reaction Conditions

  • Sep 2024
  • Nitrosamine impurity risk assessment

QMRF

Derek Nexus 6.4 Carcinogenicity QMRF

  • Sep 2024
  • Carcinogenicity assessment

QMRF

Derek Nexus version 6.4 Teratogenicity QMRF

  • Sep 2024

QMRF

Derek Nexus version 6.4 HERG QMRF

  • Sep 2024

QMRF

Sarah Nexus 4.0 Chromosome Damage QMRF

  • Sep 2024
  • Genotoxic impurity evaluation

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  • Solution

  • Publication Type

  • Date

Infographic

Leveraging a high-quality toxicity database to enhance decision making for chemical safety

  • Aug 2023
  • In silico mutagenicity assessment, Non-genotoxic impurity assessment

Paper

How to resolve inconclusive predictions from defined approaches for skin sensitisation in OECD Guideline No. 497

  • Aug 2022
  • Non-genotoxic impurity assessment, Skin sensitisation assessment

Poster

Using historical negative control data to review Ames test results

  • Jul 2022
  • Aromatic Amines, Data sharing, Non-genotoxic impurity assessment

QMRF

Derek Nexus version 6.2 Chromosome damage QMRF

  • Apr 2022
  • Non-genotoxic impurity assessment

Book chapter

Chapter 7: Compound- and Class-Specific Limits for Common Impurities in Pharmaceuticals 

  • Feb 2022
  • Data sharing, Impurity and degradant control, Non-genotoxic impurity assessment

Book chapter

Chapter 3: Control Strategies for Mutagenic Impurities

  • Feb 2022
  • Impurity and degradant control, Non-genotoxic impurity assessment

Paper

Developing structure-activity relationships for N-nitrosamine activity

  • Sep 2021
  • Nitrosamine impurity risk assessment, Non-genotoxic impurity assessment, Safety profiling in drug discovery

Infographic

Could the Lhasa Cloud be the best hosting option for you? (Infographic) 

  • Aug 2021
  • Carcinogenicity assessment, Impurity and degradant control, Non-genotoxic impurity assessment, Safety profiling in drug discovery

Poster

Quantifying the nitrosamine potency distribution 

  • May 2021
  • Carcinogenicity assessment, Nitrosamine impurity risk assessment, Non-genotoxic impurity assessment

Paper

The eTRANSAFE Project on Translational Safety Assessment through Integrative Knowledge Management: Achievements and Perspectives 

  • Mar 2021
  • Data sharing, Non-genotoxic impurity assessment

Paper

Beyond adverse outcome pathways: making toxicity predictions from event networks, SAR models, data and knowledge

  • Jan 2021
  • Carcinogenicity assessment, In silico mutagenicity assessment, Non-genotoxic impurity assessment, Safety profiling in drug discovery

Book chapter

Chapter 17: Use of Lhasa Limited Products for the In Silico Prediction of Drug Toxicity

  • Jan 2021
  • In silico mutagenicity assessment, Non-genotoxic impurity assessment
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