Two Case Studies on How Study Designs Can Be Made More Informative Using Modeling and Simulation Approaches

Drug development should extract maximum information from experiments with minimized exposure of patients or experimental animals to invasive procedures and potentially harmful effects with minimized investment of time and money. Herein, two aspects of study design are explored illustrating how information can be extracted more efficiently by investigating a range of exposures within each individual by either following responses as drug concentrations decline or by within-individual dose escalation, rather than relying on steady-state cross-sectional analyses.