Genetic & In Vitro Toxicology
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Risk Assessment Process
Genetic toxicology studies are conducted to help you assess the potential for induction of genetic mutations or chromosomal damage. Our genetic toxicologists can present you with rapid, high-quality data that can inform you of potential risk during subsequent stages of development saving you time and money.
When DNA is exposed to your particular test articles, potential mutations and other damage may occur leading to cancer and/or teratogenic effects. The severity of these effects then necessitates examining whether new or existing test articles intended for human use have any impact on DNA. This genotoxic potential is an integral part of the basic toxicological information package used in the decision-making and risk assessment process of drug development. Since no single test is capable of detecting all relevant genotoxic end-points, a battery of in vitro and in vivo tests for genotoxicity is recommended by regulatory agencies.
Genetic Toxicology Screening Assays
- Mini Ames assay
- Microwell micronucleus assay
Genetic Toxicology GLP Assays
- Ames assay
- In vitro chromosomal aberration assay
- In vitro micronucleus assay
- Mouse lymphoma assay
- In vivo micronucleus assay
- In vivo alkaline comet assay
In Silico Mutagenicity Prediction
The International Conference on Harmonization (ICH) M7 guidelines for the assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals allows for the consideration of in silico predictions in place of in vitro studies. This represents a significant advance in the acceptance of Quantitative Structure-active Relationship (Q)SAR models. Two (Q)SAR prediction methodologies that complement each other should be applied for predicting the outcome of a bacterial mutagenicity assay. One methodology should be expert rule-based and the second methodology should be statistical-based.
- Leadscope Model Applier (expert rule-based and statistical based models)
Phototoxicity is defined as a toxic response elicited by topically or systemically administered photoreactive chemicals after the exposure of the body to environmental light. The 3T3 Neutral Red Uptake (NRU) Phototoxicity (PT) assay is an established in vitro assay used to evaluate the potential phototoxicity of a test article. Since recommended by European Medical Agency (EMA) and International Conference on Harmonization (ICH) guidances, the 3T3 NRU-PT assay has been used quite extensively in the pharmaceutical industry.
GLP or Non-GLP In Vitro Phototoxicity Assay
- 3T3 NRU phototoxicity assay
In Vitro Electrophysiology
hERG (human ether-a-go-go related gene) potassium current has the crucial role in determining the repolarization of cardiac action potential. Blocking the hERG channel may cause QT interval prolongation resulting in potentially fatal ventricular tachyarrhythmia called Torsade de Pointes. In vitro evaluation of drug effects on hERG potassium channels is a valuable tool for identifying potential proarrhythmic side effects in drug safety testing and the implementation of the ICH S7B guideline has been successful in preventing the introduction of potentially torsadogenic drugs to the market.
GLP or non-GLP In Vitro Electrophysiology Assay
- hERG assay