Pharmacokinetics & Toxicokinetics

Bioanalytical assays to determine serum concentration of protein biologics

Alphalyse offers development of LC-MS/MS assays for MRM quantitation of protein based biologics (peptides, therapeutic proteins, recombinant monoclonal antibodies, vaccines) for pre-clinical toxicokinetic and clinical pharmacokinetic measurements. The developed and validated bioanalytical assay can be used at Alphalyse for high-throughput measurement of serum samples in GLP compliance.

Pharmacokinetic

Pharmacokinetics (PK) describes the relationship between administered dose, the observed biological fluid concentration of the drug, and time. PK studies are an integrated part of human clinical studies to evaluate drug efficacy and safety. Bioanalytical methods are important to measure the drug concentration in biological fluids (serum, plasma, urine) collected at different time-points. Bioanalytical methods used to analyse samples from human clinical studies must be performed in compliance with GLP.

Toxicokinetic

Toxicokinetics (TK) is the generation of kinetic data to understand the relationship between administered drug dose and toxicity. It is a regulatory requirement described in ICH Guidelines for assessing systemic exposure in toxicology studies, i.e. in pre-clinical animal studies to assist setting human plasma concentration limits and safety margins. Quantification of systemic exposure is often represented by plasma, serum or blood concentration of the compound. Pre-clinical quantification assays and measurements should be performed in consistence with GLP.