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Publications

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Publication Type

Date

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

QMRF

Sarah Nexus version 4.0 Mutagenicity QMRF

  • Sep 2024
  • In silico mutagenicity assessment

QMRF

Derek Nexus version 6.4 Chromosome damage QMRF

  • Sep 2024

QMRF

Derek Nexus version 6.4 Skin sensitisation QMRF

  • Sep 2024
  • Skin sensitisation assessment

Paper

A developmental and reproductive toxicity adverse outcome pathway network to support safety assessments

  • Aug 2024
  • Safety profiling in drug discovery

Paper

Leveraging ICH M7 Control Options 3 and 4: Discussion and Clarification Using Industrial Case Studies

  • Jul 2024
  • Impurity and degradant control, Nitrosamine impurity risk assessment

Poster

Review of methods to generate genotoxicity information and their ability to provide insight into carcinogenicity risk assessments

  • Jul 2024
  • Carcinogenicity assessment, In silico mutagenicity assessment

Paper

Structuring expert review using AOPs: Enabling robust weight-of-evidence assessments for carcinogenicity under ICH S1B(R1)

  • Jun 2024
  • Carcinogenicity assessment

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  • Date

Infographic

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

  • Aug 2023
  • In silico mutagenicity assessment, Toxicity assessment of impurities

Paper

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

  • Aug 2022
  • Skin sensitisation assessment, Toxicity assessment of impurities

Poster

Using historical negative control data to review Ames test results

  • Jul 2022
  • Aromatic Amines, Data sharing, Toxicity assessment of impurities

Book chapter

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

  • Feb 2022
  • Data sharing, Impurity and degradant control, Toxicity assessment of impurities

Book chapter

Chapter 3: Control Strategies for Mutagenic Impurities

  • Feb 2022
  • Impurity and degradant control, Toxicity assessment of impurities

Paper

Developing structure-activity relationships for N-nitrosamine activity

  • Sep 2021
  • Nitrosamine impurity risk assessment, Safety profiling in drug discovery, Toxicity assessment of impurities

Infographic

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

  • Aug 2021
  • Carcinogenicity assessment, Impurity and degradant control, Safety profiling in drug discovery, Toxicity assessment of impurities

Poster

Quantifying the nitrosamine potency distribution 

  • May 2021
  • Carcinogenicity assessment, Nitrosamine impurity risk assessment, Toxicity assessment of impurities

Paper

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

  • Mar 2021
  • Data sharing, Toxicity assessment of impurities

Paper

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

  • Jan 2021
  • Carcinogenicity assessment, In silico mutagenicity assessment, Safety profiling in drug discovery, Toxicity assessment of impurities

Book chapter

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

  • Jan 2021
  • In silico mutagenicity assessment, Toxicity assessment of impurities

Infographic

Who is using Vitic? Infographic

  • May 2020
  • Toxicity assessment of impurities
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