In response to customer demand, CXR now provides in vitro dermal absorption studies to GLP. These studies are used to predict human exposure, and are required for the safety testing of topically applied pharmaceuticals, new and re-registered agrochemicals, consumer products and chemicals. CXR will assist in designing and interpreting an appropriate study for screening, bioequivalence or registration support.
Services available at CXR include the following:
- Designing, running and interpreting dermal absorption studies as part of the risk assessment process (as per OECD Test Guideline No. 428, and relevant industry guidance if applicable)
- Custom study design for screening of chemical candidates and/or formulation selection
- Determination of potential bioequivalence by absorption profile
- Bioanalysis using labelled or non-labelled test material
Our dedicated new dermal laboratory is equipped with both static and flow-through diffusion chambers. Human skin is obtained from surgery, with full ethics approval and patient consent, and all skin samples are tested for integrity. Validation data is available on request.
CXR has an expert team with many years of industrial experience in:
- Designing and running dermal absorption studies for agrochemicals, chemicals, consumer products and dermally applied pharmaceuticals
- Quantitative analysis of biological samples, using labelled methods (e.g. scintillation counting) and non-labelled methods (e.g. LC-MS-MS, GC-MS, HPLC-UV). CXR also has particular expertise in analytical method development, and in the analysis of complex mixtures
- Generating and applying preclinical data to the risk assessment of agrochemicals, chemicals, pharmaceuticals and consumer products
CXR is also establishing mechanistic dermal metabolism and toxicology models and capabilities.
For further information about our services, or to discuss a specific issue, please contact us.