Analytical control is necessary as test compounds are, with very few exceptions,
administered after mixing with a carrier, often in very low concentrations.
The carrier may be a solid (i.e. when the test item is mixed into a diet
or lactose), or a liquid (i.e. when the test item is prepared as a solution
- for injection or oral gavage) or is suspended in a viscous material (for oral
gavage or dermal application). Regulatory Authority Guidelines for Good Laboratory
Practice recognise the scientific requirement for verification of formulations
for achieved concentration, homogeneity and stability in order to provide integrity
to pre-clinical safety evaluation studies.
We will undertake the following range of diverse activities:
- Transfer or develop and validate analytical methods based on new technologies
- Provide characterisation and purity assessment of test substances
- Assess the homogeneity / physical stability and the chemical compatibility
of formulations, undertaken according to sponsor requirements
- In study analysis, assessment of formulations prepared during the course of
the study for achieved concentration of the test compound
Analytical support is provided to safety evaluation programmes in toxicity studies (all species), reproductive studies, in vivo and in vitro genetic studies, metabolism and pharmacology. There is a specialist analytical support and expertise for hERG and Purkinje fibre studies.
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