Drug development and the FDA's Critical Path Initiative.
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.
Woosley
R L
RL
The Critical Path Institute, Tucson, Arizona, USA. Rwoosley@C-Path.org
Cossman
J
J
D035843:Biomedical Research / Q000458:organization & administration*; D002986:Clinical Trials as Topic; D004345:Drug Industry / Q000458:organization & administration*; D006801:Humans; D007373:Interinstitutional Relations; D010601:Pharmacology, Clinical / Q000458:organization & administration*; D014481:United States; D014486:United States Food and Drug Administration