Publications

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Carcinogenicity assessment

Data sharing

Impurity and degradant control

In silico mutagenicity assessment

Metabolite identification and analysis

Nitrosamine impurity risk assessment

Non-genotoxic impurity assessment

Safety profiling in drug discovery

Skin sensitisation assessment

Publication Type

Date

Paper

Evaluating the ability of defined approaches to predict the human skin sensitisation potential of chemicals previously untested in new approach methodologies

Paper

Computational mechanistic study on N-nitrosation reaction of secondary amines

Poster

Using an AOP framework to identify the most human-relevant test species – for confident single-species DART assessments

Paper

Nitrite testing in excipients – Industry best practices

Poster

Can the Second Species Be Replaced by an Adverse Outcome Pathway-Based In Silico Model?

Paper

Evaluating the Lifetime Cumulative Dose as a Basis for Carcinogenic potency of Nitrosamines

Paper

Drug Substance and Drug Product Workflows for Quality Risk Management for the Presence of Nitrosamines in Medicines

Paper

HESI GTTC Ring Trial: Concordance between Ames and Rodent Carcinogenicity Outcomes for N-Nitrosamines (NAs) with Rat and Hamster Metabolic Conditions

Infographic

How to overcome the critical challenges faced in forced degradation studies

Paper

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

Paper

Data-driven federated learning in drug discovery with knowledge distillation

Paper

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