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

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. Clinical Pharmacology & Therapeutics (2007) 81 , 24–26. doi: 10.1038/sj.clpt.6100058