
- F. P. FDA/CDER/"Purdie, “Scientific Considerations in Demonstrating Biosimilarity to a Reference Product Guidance for Industry,” p. 27, 2015.
- FDA, “Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations.” Center for Biologics Evaluation and Research, May 2019.
- T. Stangler and M. Schiestl, “Similarity assessment of quality attributes of biological medicines: the calculation of operating characteristics to compare different statistical approaches,” AAPS Open, vol. 5, no. 1, p. 4, Dec. 2019, doi: 10.1186/s41120-019-0033-9.
- EMA, “Reflection paper on statistical methodology for the comparative assessment of quality attributes in drug development,” p. 21, 2021.
- T. Zahel, “A Novel Bootstrapping Test for Analytical Biosimilarity,” AAPS J, vol. 24, no. 6, p. 112, Oct. 2022, doi: 10.1208/s12248-022-00749-3.
- G. B. Limentani, M. C. Ringo, F. Ye, M. L. Berquist, and E. O. McSorley, “Beyond the t-test: statistical equivalence testing,” Anal. Chem., vol. 77, no. 11, pp. 221A-226A, Jun. 2005.
- R. K. Burdick, “Statistical Considerations for Comparative Assessment of Quality Attributes,” Statistics in Biopharmaceutical Research, pp. 1–6, Jun. 2020, doi: 10.1080/19466315.2020.1767194.