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Articles

Sample size requirement in analytical studies for similarity assessment

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Pages 233-238 | Received 06 Aug 2016, Accepted 16 Oct 2016, Published online: 11 Jan 2017

References

  • Chen, Y. M., Weng, Y. T., Dong, X., Tsong, Y. (2016). Wald tests for variance-adjusted equivalence assessment with normal endpoints. Journal of Biopharmaceutical Statistics To appear.
  • Chow, S. C. (2014). On assessment of analytical similarity in biosimilar studies. Drug Designing Open Access 3:e124. doi:10.4172/2169-0138.1000e124
  • Chow, S. C. (2015). Challenging issues in assessing analytical similarity in biosimilar studies. Biosimilars 5:33–39.
  • Chow, S. C., Shao, J., Wang, H. (2007). Sample Size Calculation in Clinical Research, 2nd ed. New York, NY: Taylor & Francis.
  • Chow, S. C., Song, F. Y., Bai, H. (2016). Analytical similarity assessment in biosimilar studies. AAPS Journal. doi:10.1208/s12248-016-9882-5.
  • Christl, L. (2015). Overview of regulatory pathway and FDA’s guidance for development and approval of biosimilar products in US Presented at FDA ODAC meeting, January 7, 2015, Silver Spring, Maryland.
  • Dong, X., Bian, Y., Tsong, Y., Wang, T. (2017). Exact test statistics based on approach for equivalence test with random margins. Journal of Biopharmaceutical Statistics, To appear.
  • Dong, X., Tsong, Y., Weng, Y. T. (2017). Adjustment for unbalanced sample size for analytical biosimilar equivalence assessment. Journal of Biopharmaceutical Statistics, To appear.
  • FDA. (2015). Guidance on Scientific Considerations in Demonstrating Biosimilarity to a Reference Product. Maryland, USA: The United States Food and Drug Administration, Silver Spring.
  • Haidar, S. H., Davit, B., Chen, M. L., Conner, D., Lee, L., Li, Q. H., Lionberger, R., Makhlouf, F., Patel, D., Schuirmann, D. J., Yu, L. X. (2008). Bioequivalence approaches for highly variable drugs and drug products. Pharmaceutical Research, 25:237–241.
  • Tsong, Y. (2015). Analytical Similarity Assessment. Presented at Duke-Industry Statistics Symposium, Durham, North Carolina. October 22–23, 2015.
  • Wang, T. R., Chow, S. C. (2015). On establishment of equivalence acceptance criterion in analytical similarity assessment. Presented at Poster Session of the 2015 Duke-Industry Statistics Symposium, Durham, North Carolina, October 22–23, 2015.

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