354
Views
10
CrossRef citations to date
0
Altmetric
Original Articles

Equivalence Tests for Interchangeability Based on Two One-Sided Probabilities

, &
Pages 1332-1348 | Received 07 Oct 2013, Accepted 07 May 2014, Published online: 31 Oct 2014

REFERENCES

  • Berger, R. L., Hsu, J.C. (1996), Bioequivalence trials, intersection–union tests and equivalence confidence sets. Statistical Science 11(4):283–319.
  • Chang, Y.-W., Tsong, Y., Dong, X. (2014). Sample size determination for a three-arm equivalence trial of normally distributed responses. Journal of Biopharmaceutical Statistics 24(6):XX–XX.
  • Chinchilli, V. M. and Esinhart, J. D. (1996). Design and analysis of intra-subject variability in crossover experiments. Statistics in Medicine 15:1619–1634.
  • Chow, S.-C. (1999). Individual bioequivalence—A review of the FDA draft guidance. Drug Information Journal 33:435–444.
  • Chow, S.-C., Hsieh, T.-C., Chi, E., Yang, J. (2010). A comparison of moment based and probability-based criteria for follow-on biologics. Journal of Biopharmaceutical Statistics 20:1, 31–35.
  • Dong, X., Tsong, Y. (2014). Equivalence assessment for interchangeability based on two sided tests. Journal of Biopharmaceutical Statistics 24(6):XX–XX.
  • Esinhart, J. D., Chinchilli, V. M. (1994). Sample size considerations for assessing individual bioequivalence based on the method of tolerance interval. International Journal of Clinical Pharmacology and Therapeutics 32:1, 26–32.
  • Esinhart, J. D., Chinchilli, V. M. (1994). Extension to the use of tolerance interval for assessment of individual bioequivalence. Journal of Biopharmaceutical Statistics. 4:1, 39–52.
  • Food and Drug Administration. (1999). FDA Draft Guidance for Industry. Average, Population, and Individual Approaches to Establishing Bioequivalence. Rockville, MD: Center for Drug Evaluation and Research, Food and Drug Administration.
  • Food and Drug Administration. (2001). FDA Guidance for Industry. Statistical Approach to Establishing Bioequivalence. U.S. Department of Health and Human Services. Rockville, MD: Center for Drug Evaluation and Research, Food and Drug Administration.
  • Food and Drug Administration. (2003). FDA Guidance for Industry. Bioavailability and Bioequivalence Studies for Orally Administered Drug Products—General Considerations. U.S. Department of Health and Human Services. Rockville, MD: Center for Drug Evaluation and Research, Food and Drug Administration.
  • Hall, I. J. (1984). Approximated one-sided tolerance interval for the difference or sum of two independent normal variables. Journal of Quality Technology 16:15–1.
  • Liu, J-P., Chow, S.-C. (1999). Some thoughts on individual bioequivalence. Journal of Biopharmaceutical Statistics 16:861–874.
  • 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 7(1):41–48.
  • Tsong, Y., Shen, M. (2007). An alternative approach to assess exchangeability of a test treatment and the standard treatment with normally distributed response. Journal of Biopharmaceutical Statistics 17:329–338.
  • Tsong, Y., Shen, M., Lostritto, R.T., Poochikian, G.K. (2008). Parametric two-tier sequential quality assurance test of delivery dose uniformity of multiple-dose inhaler and dry powder inhaler drug products. Journal of Biopharmaceutical Statistics 18(5):976–984.

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.