A5053704908- Water Treatment and Disinfection
- Carcinogens and Genotoxicity Assessment
- Sulfur Compounds in Biology
- Environmental Toxicology and Ecotoxicology
- Chemical Safety and Risk Management
- Toxic Organic Pollutants Impact
- Antimicrobial agents and applications
- Chemical Reactions and Isotopes
- Pharmaceutical and Antibiotic Environmental Impacts
- Animal testing and alternatives
- Atmospheric chemistry and aerosols
Stratophase (United Kingdom)
2021
Under ICH M7, impurities are assessed using the bacterial reverse mutation assay (i.e., Ames test) when predicted positive in silico methodologies followed by expert review. N-Nitrosamines (NAs) have been of recent concern as pharmaceuticals, mainly because their potential to be highly potent mutagenic carcinogens rodent bioassays. The purpose this analysis was determine sensitivity predict carcinogenic outcome with curated proprietary Vitic (n = 131) and Leadscope 70) databases. NAs were...
The tumorigenic dose 50 (TD
Carcinogenic potency is a key factor in the understanding of chemical risk assessment. Measures carcinogenic potency, for example TD
The use of in silico predictions for the assessment bacterial mutagenicity under International Council Harmonisation Technical Requirements Pharmaceuticals Human Use (ICH) M7 guideline is recommended when two complementary (quantitative) structure-activity relationship (Q)SAR models are used. Using systems may increase sensitivity and accuracy but also increases need to review predictions, particularly situations where results disagree. During 4th ICH M7/QSAR Workshop held during Joint...
Mutagenicity data is a core component of the safety assessment required by regulatory agencies for acceptance new drug compounds, with OECD-471 bacterial reverse mutation (Ames) assay most widely used as primary screen to assess impurities potential mutagenic risk. N-Nitrosamines are highly potent carcinogens in rodent bioassays and their recent detection pharmaceutical products has sparked increased interest assessment. Previous literature reports indicated that Ames test might not be...