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Clin Pharmacol Ther. 2007 Jan;81(1):24-6.

Nontraditional approaches to first-in-human studies to increase efficiency of drug development: will microdose studies make a significant impact?

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  • 1Clinical Pharmacology, Pfizer Global Research and Development, Ann Arbor, Michigan, USA.


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.

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