Estimation and Approximation Approaches for Biosimilar Index Based on Reproducibility Probability

REFERENCES

• Chow, S. C. (2011). Quantitative evaluation of bioequivalence/biosimilarity. Journal of Bioequivalence and Bioavailability Suppl. 1-002:1–8.
   Google Scholar
• Chow, S. C., Ju, C. (2013). Assessing biosimilarity and interchangeability of biosimilar products under the Biologics Price Competition and Innovation Act. Generics and Biosimilars Initiative Journal 2(1):20–25.
   Google Scholar
• Chow, S. C., Liu, J. P. (2009). Statistical assessment of biosimilar products. Journal of Biopharmaceutical Statistics 20(1):10–30.
   Web of Science ®Google Scholar
• 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.
   PubMed Web of Science ®Google Scholar
• Chow, S. C., Wang, J., Endrenyi, L., Lachenbruch, P. A. (2013). Scientific considerations for assessing biosimilar products. Statistics in Medicine 32:370–381.
   PubMed Web of Science ®Google Scholar
• Chow, S. C., Yang, L. Y., Starr, A., Chiu, S. T. (2013). Statistical methods for assessing interchangeability of biosimilars. Statistics in Medicine 32(3): 442–448.
   PubMed Web of Science ®Google Scholar
• Cohen, J. (1992). A power primer. Psychological Bulletin 112 (1): 155–159.
   PubMed Web of Science ®Google Scholar
• Cousineau, D. (2007). Computing the power of a t test. Tutorials in Quantitative Methods for Psychology 3:60–62.
   Google Scholar
• Cousineau, D., Laurencelle, L. (2011). Non-central t distribution and the power of the t test: A rejoinder. Tutorials in Quantitative Methods for Psychology 7:1–4.
   Google Scholar
• De Martini, D. (2008). Reproducibility probability estimation for testing statistical hypotheses. Statistics and Probability Letters 78:1056–1061.
   Web of Science ®Google Scholar
• European Medicines Agency. (2005). Guideline on Similar Biological Medicinal Products. The European Medicines Agency Evaluation of Medicines for Human Use. EMEA/CHMP/437/04. London, UK: EMA.
   Google Scholar
• European Medicines Agency. (2013). Guideline on Similar Biological Medicinal Products. The European Medicines Agency Evaluation of Medicines for Human Use. CHMP/437/04 Rev 1. London, UK: EMA.
   Google Scholar
• Food and Drug Administration. (2005). Q5E Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process. Rockville, MD: U.S. Food and Drug Administration.
   Google Scholar
• Food and Drug Administration. (2012a). Scientific Considerations in Demonstrating Biosimilarity to a Reference Product. Silver Spring, MD: U.S. Food and Drug Administration.
   Google Scholar
• Food and Drug Administration. (2012b). Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product. Silver Spring, MD: U.S. Food and Drug Administration.
   Google Scholar
• Food and Drug Administration. (2012c). Draft Guidance on Scientific Considerations in Demonstrating Biosimilarity to a Reference Product. Rockville, MD: Center for Drug Evaluation and Research, U.S> Food and Drug Administration.
   Google Scholar
• Fox, A. (2010). Biologics vs. small molecule drugs. Journal of Biopharmaceutical Statistics 20(1):3–9.
   PubMed Web of Science ®Google Scholar
• Hsieh, E., Chow, S. C., Liu. J. P., Hsiao, C. F., Chi, E., Yang, J. (2010) Statistical test for evaluation of biosimilarity in variability of follow-on biologics. Journal of Biopharmaceutical Statistics 20:74–88.
   Google Scholar
• Hsieh, T. C., Chow, S. C., Yang, L. Y., Chi, E. (2013). The evaluation of biosimilarity index based on reproducibility probability for assessing follow-on biologics. Statistics in Medicine 32(3):406–414.
   PubMed Web of Science ®Google Scholar
• Jennett, W. J., Welch, B. L. (1939). The control of proportion defective as judged by a single quality characteristic varying on a continuous scale. Supplement to the Journal of the Royal Statistical Society 6(1):80–88.
   Google Scholar
• Johnson, N. L., Kotz, S., Balakrishnan, N. (1995). Continuous Univariate Distributions, 2nd ed. New York, NY: Wiley.
   Google Scholar
• Nakagawa, S., Cuthill, I. C. (2007). Effect size, confidence interval and statistical significance: a practical guide for biologists. Biological Reviews, Cambridge Philosophical Society 82(4):591–605.
   PubMed Web of Science ®Google Scholar
• Nick, C. (2012). The US Biosimilars Act: Challenges facing regulatory approval. Pharmaceutical Medicine 26(3):145–152.
   Google Scholar
• Rosnow, R. L., Rosenthal, R. (1996). Computing contrasts, effect sizes, and counternulls on other people’s published data: General procedures for research consumers. Psychological Methods 1:331–340.
   Web of Science ®Google Scholar
• Rosnow, R. L., Rosenthal, R. (2003). Effect sizes for experimenting psychologists. Canadian Journal of Experimental Psychology 57:221–237.
   PubMed Web of Science ®Google Scholar
• Shao, J., Chow, S. C. (2002). Reproducibility probability in clinical trials. Statistics in Medicine 21(12):1727–1742.
   PubMed Web of Science ®Google Scholar