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

Clin Pharmacol Ther. 2007 Jan;81(1):24-6. doi: 10.1038/sj.clpt.6100058.

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 types

  • Comment

MeSH terms

  • Clinical Trials, Phase I as Topic / methods*
  • Dose-Response Relationship, Drug
  • Drug Industry / methods*
  • Human Experimentation
  • Humans
  • Pharmacokinetics
  • United States
  • United States Food and Drug Administration