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Commentary on “Statistical Approaches to Assess Biosimilarity from Analytical Data” by Burdick et al [1]

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References

  1. Burdick R, Coffey T, Gutka H, Gratzl G, Conlon HD, Huang CT, et al. Statistical approaches to assess biosimilarity from analytical dat. AAPS J. 2016; In press.

  2. Dong X, Weng YT, Tsong Y. Adjustment for imbalanced sample size for analytical biosimilar equivalence assessment. J Biopharm Stat. 2016; In press.

  3. Chen YM, Weng YT, Dong X, Tsong Y. Wald tests for variance-adjusted equivalence assessment with normal endpoints. J Biopharm Stat. 2016; In press.

  4. Dong X, Bian YY, Tsong Y. Statistical approaches for equivalence test with random margin. J Biopharm Stat. 2016; Submitted.

  5. Shen M, Wang T, Tsong Y. Statistical consideration regarding to cor- related lots in analytical biosimilar equivalence test. J Biopharm Stat. 2016; In press.

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Authors and Affiliations

  1. US Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, Maryland, 20993, USA

    Yi Tsong & Yu-Ting Weng

  2. Temple University, 1801 N Broad St, Philadelphia, Pennsylvania, 19122, USA

    Qi Xia

Authors
  1. Yi Tsong
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  2. Qi Xia
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  3. Yu-Ting Weng
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Corresponding author

Correspondence to Yi Tsong.

Additional information

See related article, doi:10.1208/s12248-016-9968-0.

This article reflects the views of the author and should not be construed to represent FDA’s views or policies.

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Tsong, Y., Xia, Q. & Weng, YT. Commentary on “Statistical Approaches to Assess Biosimilarity from Analytical Data” by Burdick et al [1] . AAPS J 19, 15–17 (2017). https://doi.org/10.1208/s12248-016-9987-x

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  • DOI: https://doi.org/10.1208/s12248-016-9987-x

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