title: Issues, challenges, and opportunities in model-based drug development for monoclonal antibodies.
abstract: Over the last two decades, there has been a simultaneous explosion in the levels of activity and capability in both monoclonal antibody (mAb) drug development and in the use of quantitative pharmacologic models to facilitate drug development. Both of these topics are currently areas of great interest to academia, the pharmaceutical and biotechnology industries, and to regulatory authorities. In this article, we summarize convergence of these two areas and discuss some of the current and historical applications of the use of mathematical-model-based techniques to facilitate the discovery and development of mAb therapeutics. We also consider some of the current issues and limitations in model-based antibody discovery/development and highlight areas of further opportunity.
authors.affiliation: Eli Lilly and Company, Drug Disposition and PK/PD, Indianapolis, Indiana.
authors.forename: Leijun
authors.initials: L
authors.lastname: Hu
authors.forename: Ryan J
authors.initials: RJ
authors.lastname: Hansen
mesh_terms: D000818:Animals; D000911:Antibodies, Monoclonal / Q000493:pharmacokinetics* / Q000494:pharmacology*; D019295:Computational Biology; D055808:Drug Discovery / Q000379:methods*; D006801:Humans; D008954:Models, Biological
chemical_list: D000911:Antibodies, Monoclonal
keywords: PK/PD; allometry; antibody; computational biology; nonlinear pharmacokinetics; pharmacodynamics; pharmacokinetics; pharmacokinetics/pharmacodynamics; physiological model