Commentary
Clinical Pharmacology & Therapeutics (2007) 81, 24–26. doi:10.1038/sj.clpt.6100058
Nontraditional approaches to first-in-human studies to increase efficiency of drug development: will microdose studies make a significant impact?
1Clinical Pharmacology, Pfizer Global Research and Development, Ann Arbor, Michigan, USA
Correspondence: RL Lalonde, richard.lalonde@pfizer.com
Abstract
Much has been written recently about low productivity in the pharmaceutical industry and the high cost of drug development.1, 2 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.1 Attrition was highest during phase II (62%) but still significant in phase III (45%) and at the time of registration (23%).1 Clearly, given the high cost and time required for clinical development, these late-stage failures are unsustainable.
