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Harmonization of regulatory approaches for evaluating therapeutic equivalence and interchangeability of multisource

Mei-Ling Chen1, Vinod P Shah, Daan J Crommelin

  • 1Office of Pharmaceutical Science, Center forDrug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993-0002, USA. meiling.chen@fda.hhs.gov

European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences
|September 28, 2011
PubMed

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