Methods to determine pharmacokinetic profiles of therapeutic proteins

With an increasing number of therapeutic proteins moving into clinical development program, pharmacokinetics (PK) plays an important role in the development of these macromolecules. For macromolecules, the evaluation of PK parameters is often complicated by several factors, such as choosing the appropriate bio-analytical methods, immunogenicity, route of administration and endogenous concentrations. Despite these difficulties, it is important that the PK evaluation of these compounds be done as accurately as possible.

Section editors:Marco van de Weert and Eva Horn Moeller – Department of Pharmaceutics and Analytical Chemistry, Faculty of Pharmaceutical Sciences, University of Copenhagen, Copenhagen, Denmark