Stopping Guidelines for Harm in a Study Designed to Establish the Safety of a Marketed Drug

Alex N. Fleishman, Robert A. Parker
  • Journal of Biopharmaceutical Statistics, January 2012, Taylor & Francis
  • DOI: 10.1080/10543406.2010.536872

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http://dx.doi.org/10.1080/10543406.2010.536872