Paving the Critical Path: How can Clinical Pharmacology Help Achieve the Vision? Export

@article{citeulike:3513308, abstract = {It has been almost 3 years since the launch of the FDA critical path initiative following the publication of the paper "Innovation or Stagnation: Challenges and Opportunities on the Critical Path of New Medical Product Development." The initiative was intended to create an urgency with the drug development enterprise to address the so-called "productivity problem" in modern drug development. Clinical pharmacologists are strategically aligned with solutions designed to reduce late phase clinical trial failures to show adequate efficacy and/or safety. This article reviews some of the ways that clinical pharmacologists can lead and implement change in the drug development process. It includes a discussion of model-based, semi-mechanistic drug development, drug/disease models that facilitate informed clinical trial designs and optimal dosing, the qualification process and criteria for new biomarkers and surrogate endpoints, approaches to streamlining clinical trials and new types of interaction between industry and FDA such as the end-of-phase 2A and voluntary genomic data submission meetings respectively.}, author = {Lesko, L. J.}, citeulike-article-id = {3513308}, citeulike-linkout-0 = {http://dx.doi.org/10.1038/sj.clpt.6100045}, citeulike-linkout-1 = {http://dx.doi.org/10.1038/6100045a}, citeulike-linkout-2 = {http://view.ncbi.nlm.nih.gov/pubmed/17259944}, citeulike-linkout-3 = {http://www.hubmed.org/display.cgi?uids=17259944}, day = {01}, doi = {10.1038/sj.clpt.6100045}, issn = {0009-9236}, journal = {Clinical Pharmacology \& Therapeutics}, keywords = {critical, fda, path}, month = {February}, number = {2}, pages = {170--177}, posted-at = {2008-11-14 14:55:35}, priority = {2}, publisher = {Nature Publishing Group}, title = {Paving the Critical Path: How can Clinical Pharmacology Help Achieve the Vision?}, url = {http://dx.doi.org/10.1038/sj.clpt.6100045}, volume = {81}, year = {2007} }

TY - JOUR ID - citeulike:3513308 L3 - citeulike-article-id:3513308 N2 - It has been almost 3 years since the launch of the FDA critical path initiative following the publication of the paper "Innovation or Stagnation: Challenges and Opportunities on the Critical Path of New Medical Product Development." The initiative was intended to create an urgency with the drug development enterprise to address the so-called "productivity problem" in modern drug development. Clinical pharmacologists are strategically aligned with solutions designed to reduce late phase clinical trial failures to show adequate efficacy and/or safety. This article reviews some of the ways that clinical pharmacologists can lead and implement change in the drug development process. It includes a discussion of model-based, semi-mechanistic drug development, drug/disease models that facilitate informed clinical trial designs and optimal dosing, the qualification process and criteria for new biomarkers and surrogate endpoints, approaches to streamlining clinical trials and new types of interaction between industry and FDA such as the end-of-phase 2A and voluntary genomic data submission meetings respectively. IS - 2 JF - Clinical Pharmacology & Therapeutics SN - 0009-9236 EP - 177 TI - Paving the Critical Path: How can Clinical Pharmacology Help Achieve the Vision? PB - Nature Publishing Group VL - 81 SP - 170 KW - critical KW - fda KW - path AU - Lesko, LJ PY - 2007/02/01/ UR - http://dx.doi.org/10.1038/sj.clpt.6100045 ER -