PK/TK Assays

It is imperative to have a good understanding of pharmacokinetics (PK) for the optimization of dosing regimens of a therapeutic. We develop, optimize, and transfer PK/TK assays using methodologies such as ELISA and MSD. Traditional ELISAs  employ absorbance, fluorescence or luminescence end points.  In addition, with the Singulex platform we have the capability to measure low concentrations of a given drug (e.g. micro-dosing studies) thereby providing a more complete PK profile. Our validations follow FDA and EMEA guidances and all relevant industry standards, and are managed by our experienced, knowledgeable staff.