Publications

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Solution

Publications Specific Solution Area

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

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

May 2025
Nitrosamine impurity risk assessment

Paper

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

May 2025
Carcinogenicity assessment, Nitrosamine impurity risk assessment

Infographic

How to overcome the critical challenges faced in forced degradation studies

Mar 2025
Impurity and degradant control

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

Filter by:

Solution
- Carcinogenicity assessment
- Data sharing
- Genotoxic impurity evaluation
- 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