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Original Articles

Statistical Test for Evaluation of Biosimilarity in Variability of Follow-On Biologics

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Pages 75-89 | Received 01 Mar 2009, Accepted 01 Jun 2009, Published online: 12 Jan 2010

REFERENCES

  • Chow , S. C. , Liu , J. P. ( 2008 ). Design and Analysis of Bioavailability and Bioequivalence Studies. , 3rd ed. New York : Chapman Hall/CRC Press, Taylor & Francis .
  • Chow , S. C. , Hsieh , E. , Chi , E. , Yang , J. ( 2010 ). A comparison of moment-based and probability-based criteria for assessment of follow-on biologics . Journal of Biopharmaceutical Statistics 20 ( 1 ): 31 – 45 .
  • Food and Drug Administration. ( 2003 ). Guidance on Bioavailability and Bioequivalence Studies for Orally Administrated Drug Products—General Considerations. Rockville, MD: Center for Drug Evaluation and Research, U.S. Food and Drug Administration .
  • Fox , A. ( 2010 ). Biologics vs. small molecule drugs . Journal of Biopharmaceutical Statistics 20 ( 1 ): 3 – 9 .
  • Tse , S. K. , Chang , J. Y. , Su , W. L. , Chow , S. C. , Hsiung , C. , Lu , Q. ( 2006 ). Statistical quality control process for traditional Chinese medicine . Journal of Biopharmaceutical Statistics 16 : 861 – 874 .

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