Phase 0 trials: a platform for drug development?

  title={Phase 0 trials: a platform for drug development?},
  author={T. Lancet},
  journal={The Lancet},
  • T. Lancet
  • Published 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… CONTINUE READING
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