title: Nontraditional approaches to first-in-human studies to increase efficiency of drug development: will microdose studies make a significant impact?
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.
authors.affiliation: Clinical Pharmacology, Pfizer Global Research and Development, Ann Arbor, Michigan, USA.
authors.forename: R A
authors.initials: RA
authors.lastname: Boyd
authors.forename: R L
authors.initials: RL
authors.lastname: Lalonde
mesh_terms: D017321:Clinical Trials, Phase I as Topic / Q000379:methods*; D004305:Dose-Response Relationship, Drug; D004345:Drug Industry / Q000379:methods*; D006805:Human Experimentation; D006801:Humans; D010599:Pharmacokinetics; D014481:United States; D014486:United States Food and Drug Administration