It is imperative to have a good understanding of pharmacokinetics (PK) for the optimization of dosing regimens of a therapeutic. Smithers, a bioanalytical contract research organization (CRO), develops, optimizes, and transfers PK/TK assays employing platforms including, ELISA, MSD, Gyros, Singulex, and Quanterix. Traditional ELISAs employ absorbance, fluorescence or luminescence end points. In addition, with the Singulex and Quanterix platforms, we have the capability to measure low concentrations of a given drug (e.g. micro-dosing studies) thereby providing a more complete PK profile.
Smithers validations follow FDA, EMA, and all relevant industry guidances, and are directed by our expert project management team.