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.
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