Safety Pharmacology / Toxicity Testing
Toxicity testing and safety pharmacology assessment of new chemical entities is a complex process that incorporates information from in silico analyses, in vitro studies, and animal testing. The FDA is actively investigating technologies that can better predict toxicity early in the discovery process. An increased need for validated, physiologically relevant, and predictive cytotoxicity tests has been triggered by several recent events:
- High attrition rate of new drugs in development
- Withdrawal of marketed drugs due to toxicity
- Increased focus on animal welfare issues due to regulatory changes
FUJIFILM Cellular Dynamics’ iPSC cell platform offers a novel approach to in vitro toxicity testing that overcomes many limitations of existing models. Benefits include:
- Biologically relevant human cell models
- Highly reproducible, high-purity iCell® products to ensure confidence in results
- Consistent availability to eliminate the need for repeat sourcing and validation
Our iCell Cardiomyocytes have been extensively evaluated as a human model for predicting drug-induced cardiac arrhythmia within the Comprehensive in-vitro proarrhythmia assay (CiPA) initiative. In addition, iCell Hepatocytes show promise as an early stage indicator of liver damage, and iCell GABANeurons, GlutaNeurons and Microglia are being used as a model systems for studying neurotoxic properties of candidate compounds.
