FACTORS LEADING TO ERRONEOUS PKPD INTERPRETATION

The ultimate goals of preclinical and early clinical studies are to characterize a drug’s efficacy and safety, and in so doing, assess the medical utility and chance of success in a respective target patient population as early and accurately as possible. Over the last decade, various approaches have been proposed and exercised to address this goal, which has recently been termed “translational science” in pharmaceutical development. Several state-of-the-art technologies in this area were highlighted in JSSX’s official journal (DMPK) in the first 2009 (Theme) Issue. These articles introduce translational pharmacokinetic and pharmacodynamic (PKPD) approaches with modeling and simulation tools. They consider biologic, physiologic and mechanistic insight to both inform decisions and identify key parameters to be investigated in early exploratory stages.