Journal of Bioequivalence & Bioavailability

Abstract

The Application of Proteomics to PK-PD Modeling and Simulation

Ken-Ichi Sako, Hisao Haniu, Mayumi Hasegawa, Hirohisa Doi, Shunsuke Yano, Yuichiro Oosawa, Tohru Kishino, Yoshihiko Matsuki, Yumiko Arisue, Takeshi Kawamura, Masayuki Kimura and Yoshikazu Matsuda

Pharmacokinetic-pharmacodynamic (PK-PD) modeling and simulation can be an invaluable tool for use in making crucial decisions in drug development and clinical settings, including those pertaining to compound selection, dose selection, study design, and patient population, all of which can impact the cost of development and treatment. Clinical PK-PD modeling and simulation of antimicrobial agents are possible because minimum inhibitory concentration (MIC) values can be easily measured in the hospital laboratory. However, no such easily measured clinical markers are available for many other types of drugs. In this point of view, we thought that the proteomics approach may be available for find the direct PD parameter such as drug specific biomarker. Many reports also suggest that proteomics is a promising tool in the search for drug-specific biomarker proteins that could be used in PK-PD modeling and simulation. Thus, by enabling examination of drug-induced changes in the expression of specific biomarker proteins, proteomic data could be used in PD analyses in much the same way that MICs are used in PD evaluations of antimicrobial agents.