Healthy Skepticism Library item: 7675

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Publication type: Journal Article

Woosley RL, Cossman J.
Drug development and the FDA's Critical Path Initiative.
Clin Pharmacol Ther 2007 Jan; 81:(1):129-33
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=17186012&dopt=Abstract

Abstract:

Advances in biomedical research over recent decades have substantially raised expectations that the pharmaceutical industry will generate increasing numbers of safe and effective therapies. However, there are warning signs of serious limitations in the industry’s ability to effectively translate biomedical research into marketed new therapies. Clinical pharmacologists should be aware of these signals and their potential impact. Here, we discuss a strategy, where clinical pharmacology can play an important role to improve the process of drug development.

Keywords:
MeSH Terms: Biomedical Research/organization & administration* Clinical Trials Drug Industry/organization & administration* Humans Interinstitutional Relations Pharmacology, Clinical/organization & administration* United States United States Food and Drug Administration*