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Publications

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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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  • Solution

  • Publication Type

  • Date

Paper

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

  • Mar 2021
  • Data sharing, Toxicity assessment of impurities

Paper

Guidelines for FAIR sharing of preclinical safety and off-target pharmacology data 

  • Mar 2021
  • Data sharing, In silico mutagenicity assessment

Paper

Bringing Together Scientific Disciplines for Collaborative Undertakings: A Vision for Advancing the Adverse Outcome Pathway Framework

  • Feb 2021
  • Carcinogenicity assessment, Data sharing, Safety profiling in drug discovery

Paper

Enhancing carbon acid pKa prediction by augmentation of sparse experimental datasets with accurate AIBL (QM) derived values

  • Feb 2021
  • Impurity and degradant control

Paper

Utilisation of parametric methods to improve percentile-based estimates for the carcinogenic potency of nitrosamines 

  • Feb 2021
  • Carcinogenicity assessment, Nitrosamine impurity risk assessment

Paper

Deriving compound-specific exposure limits for chemicals used in pharmaceutical synthesis: Challenges in expert decision-making exemplified through a case study-based workshop 

  • Feb 2021
  • AI/PDE, Carcinogenicity assessment, Data sharing

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

Paper

Use of Mirabilis based purge calculations to understand Nitrosamine-related risk and control strategy options

  • Dec 2020
  • Impurity and degradant control, In silico mutagenicity assessment, Nitrosamine impurity risk assessment

Infographic

Anticipating and mitigating adverse drug reactions through machine learning and privacy-preserving data sharing (infographic)

  • Nov 2020
  • Data sharing, Safety profiling in drug discovery

Infographic

Could purge calculations support your regulatory submissions? (Infographic)

  • Oct 2020
  • Impurity and degradant control

Paper

The importance of expert review to clarify ambiguous situations for (Q)SAR predictions under ICH M7

  • Sep 2020
  • In silico mutagenicity assessment
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