Dose Formulation in Regulary Toxicology
For regulatory toxicology studies it is required to analyse the dose formulations given to the animals for test item concentration and homogeneity. Usually, the analysis will be performed using UV-HPLC, but other techniques might also be relevant.
Scantox offers to perform the analysis of dose formulations including validation of the method, when the client does not have the capabilities or resources to do so.
Non-Clinical Dose Formulation Analysis
The analyses and validation will be performed as described in the white paper on non-clinical dose formulation analysis (see Whitmire et al, 2010). The validation can include the following parameters: specificity, sensitivity, linearity, range, precision, accuracy, homogeneity and stability.