Clearance Assays & Toxicity Testing

Element offers comprehensive, independent assessments of drug in vitro cytotoxicity and preclinical toxicology in addition to a well-developed collection of residual and clearance assays to confirm molecular clearance in animal-derived, complex matrices, including food.

Our in vitro cytotoxicity testing and preclinical toxicology study services can be combined with Element’s suite ofADME service offerings, resulting in a complete framework for DMPK-toxicology studies.

Our consultative, knowledgeable teams of scientists perform in vitro cytotoxicity assays per strict ISO 10993-5 guidelines in our purpose-built cytotoxicity testing labs, providing valuable information about candidate drug and molecule cytotoxic concentration, as well as any adverse cellular effects related to the drug or formulation.

Along with in vitro cytotoxicity, in vivo preclinical toxicology studies are critical to assessing the safety of a drug, providing drug developers and researchers with an understanding of how drug concentrations affect living organisms. Once the drug is administered to animals and samples are collected from those animals, the samples can be shipped to Element for thorough analysis.

Understanding the presence of residual drugs by testing for molecular clearance is important for both clinical trials and food safety. Element can test complex food matrices, including meat and milk, for residual drugs and chemicals that can be detrimental to human health if consumed.

Cytotoxicity & clearance assay services

• In vitro cytotoxicity testing in candidate drugs and molecules
• Expanded cytotoxicity studies to support drug development (pharmaceutical formulation, extractables and leachables, contaminant analysis, trace elements, and more)
• Preclinical toxicology studies
• Residuals and clearance assays

Note: Element does not have animal storage and care facilities. Animal samples in preclinical toxicology studies must be sent to the toxicity testing lab for analysis.

The Element advantage

Element’s experience and in-depth knowledge of the regulatory guidelines that govern toxicity and clearance testing, in addition to our comprehensive collection ofbioanalytical testing services, make Element the partner of choice for biopharmaceutical companies of all sizes, including virtual, small- and mid-size, as well large pharmaceutical organizations.

For more information about our toxicity testing lab, clearance assays, or to request a quote,contact ustoday.