The assay design used for measurement of therapeutic antibody concentrations can affect pharmacokinetic parameters: Case studies.

ABSTRACT: To interpret pharmacokinetic (PK) data of biotherapeutics, it is critical to understand which drug species is being measured by the PK assay. For therapeutic antibodies, it is generally accepted that "free" circulating antibodies are the pharmacologically active form needed to determine the PK/pharmacodynamic (PD) relationship, safety margin calculations, and dose projections from animals to humans and the eventual characterization of the exposure in the clinic. However, "total" drug may be important in evaluating the dynamic interaction between the drug and the target, as well as the total drug exposure. In the absence of or with low amounts of soluble ligand/shed receptor, total and free drug species are often equivalent and their detection is less sensitive to assay formats or reagent c

SUBMITTER: Fischer SK 

PROVIDER: S-EPMC3499303 | biostudies-literature | 2012 Sep-Oct

REPOSITORIES: biostudies-literature