Phase 0 trials: a platform for drug development?

  title={Phase 0 trials: a platform for drug development?},
  author={The Lancet},
  journal={The Lancet},
  • T. Lancet
  • Published 24 July 2009
  • Medicine
  • The Lancet
In 2006, the US Food and Drug Administration released a guidance document outlining recommendations for exploratory investigational new-drug studies. In these so-called phase 0 studies, done before traditional phase I trials, subtherapeutic doses of a new drug are given to a small group of patients (typically fewer than 15) for roughly a week to determine pharmacodynamic and pharmacokinetic properties. Researchers can then use these early data to guide further development. The results of one of… 
It is concluded that Phase “0” in clinical trials can work as a useful parameter to measure drug safety at subtherapeutic level and the fundamental requirements of clinical studies conducted under an exploratory IND are reviewed and some common misconceptions regarding phase 0 trials are addressed.
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Phase 0 clinical trials