A New Paradigm. "Learn - Learn More"; Dose-Exposure-Response at the Center of Drug Development and Regulatory Approval

Abstract

In his seminal paper, Lewis Sheiner introduced the "Learning versus Confirming" paradigm. From that foundation, this work proposes why the precise estimation of the dose-exposure-response (D-E-R) for both efficacy and safety endpoints should be the ultimate goal for most drug development programs. The subsequent identification and approval of an optimal dose regimen range will provide a pragmatic framework for delivering personalized medicine based on dose titration for each and every patient.