Genotoxicity
Helping you assess the potential risks of your starting materials, intermediates and final API
Our Genotoxicity services include the complete (Insilico and invitro) assessment of starting materials, intermediates and final API, followed by expert review for risk analysis and classification as per ICH-M7 guidelines. This constitutes an essential part of our clients' pre-clinical studies and assessment and control of mutagenic risks to ensure patient safety throughout development and into commercial supply.
Insilico Genotoxicity Assessment
- Structural scheme/analysis
- Assessment using Derek Nexus (Lhasa)
- ICH-M7 assessment using Knowledge and Statistical approaches
- Alert assessment
- ICH-M7 report generation
Our Services
In Vitro Panel
- Ames assay
- Chromosomal Aberration Assay (CA)
- Micronucleus Test (MNT)
In Vivo Panel
- Chromosomal Aberration Assay (CA)
- Micronucleus Test (MNT)
Chromosomal Aberration Assay (CA)
- In-Vitro Mammalian Chromosome Aberration Test using Human Peripheral Blood Lymphocytes
- In-Vivo Mammalian Chromosome Aberration Test using Mouse as Test System
Ames assay
- Full Ames/Micro-Ames, Bacterial Reverse Mutation Test: Traditional or Kit method, Bacterial Reverse Mutation Test using Salmonella typhimurium (5 strains and 5 concentrations)
- Mini Ames/Fluctuation Test: Traditional or Kit method, Bacterial Reverse Mutation Test using Salmonella typhimurium (2 strains and 3 concentrations)
Micronucleus Test (MNT)
- In-Vitro Micronucleus test using Human Lymphocytes
- In-Vivo Micronucleus test using Mouse as Test System applying routine procedures and standard protocol.
