Open AccessPharmacokinetic/ Pharmacodynamic‐Driven Drug Development
Author(s) -
Gallo James M.
Publication year - 2010
Publication title -
mount sinai journal of medicine: a journal of translational and personalized medicine
Language(s) - English
Resource type - Journals
eISSN - 1931-7581
pISSN - 0027-2507
DOI - 10.1002/msj.20193
Subject(s) - drug development , medicine , drug discovery , bench to bedside , translational research , clinical trial , translational science , pharmacology , pharmacodynamics , drug , pharmacokinetics , engineering ethics , bioinformatics , medical physics , engineering , pathology , biology
The drug discovery and development enterprise, traditionally an industrial juggernaut, has spanned into the academic arena that is partially motivated by the National Institutes of Health Roadmap highlighting translational science and medicine. Because drug discovery and development represents a pipeline of basic to clinical investigations, it meshes well with the “bench to the bedside” prime directive of translational medicine. The renewed interest in drug discovery and development in academia provides an opportunity to rethink the hiearchary of studies with the hope of improving the staid approaches that have been criticized for lacking innovation. One area that has received limited attention concerns the use of pharmacokinetic and pharmacodynamic studies in the drug‐development process. Using anticancer drug development as a focus, this review will address past and current deficencies in how pharmacokinetic/pharmacodynamic studies are conducted and offer new strategies that might bridge the gap between preclinical and clinical trials. Mt Sinai J Med 77:381–388, 2010. © 2010 Mount Sinai School of Medicine