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- Title
Nontraditional approaches to first-in-human studies to increase efficiency of drug development: will microdose studies make a significant impact?
- Authors
Boyd, R A; Lalonde, R L
- Abstract
Much has been written recently about low productivity in the pharmaceutical industry and the high cost of drug development. Over a 10-year period ending in 2000, only approximately 11% of compounds tested in humans across 10 large pharmaceutical companies were eventually approved for marketing in the United States and/or Europe. Attrition was highest during phase II (62%) but still significant in phase III (45%) and at the time of registration (23%). Clearly, given the high cost and time required for clinical development, these late-stage failures are unsustainable.
- Publication
Clinical pharmacology and therapeutics, 2007, Vol 81, Issue 1, p24
- ISSN
0009-9236
- Publication type
Journal Article
- DOI
10.1038/sj.clpt.6100058