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A New Paradigm. “Learn – Learn More”; Dose‐Exposure‐Response at the Center of Drug Development and Regulatory Approval
Author(s) -
Maloney Alan
Publication year - 2017
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1002/cpt.710
Subject(s) - drug development , regimen , drug , identification (biology) , medicine , medical physics , pharmacology , biology , botany
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.