On the Assessment of Average Biosimilarity Based on a Three-Arm Parallel Design
- DOI
- 10.2991/jsta.2017.16.4.7How to use a DOI?
- Keywords
- Bootstrap calibration; equivalence testing; generalized pivotal quantity; sample size determination
- Abstract
Average biosimilarity is investigated under a three-arm parallel design: one arm corresponds to the test drug T , and the other two arms correspond to two versions of the reference drug, say R1 and R2. The hypothesis of interest is the equivalence of the population average response for T with the mean of the population average responses for R_1 and R_2. The parameter of interest is formulated as the absolute difference of the above two averages, scaled by the absolute difference between the population means corresponding to R_1 and R_2. A difference parameter is also proposed. For the ratio parameter, a test can be derived using the asymptotic normality of an appropriate test statistic; however, the test is not satisfactory in terms of type I error probabilities. Improved tests are derived by applying a bootstrap calibration, and by using the idea of a generalized pivotal quantity (gpq). The tests are developed under equal variance and unequal variance scenarios. Sample size determination is also addressed. For the difference parameter, a satisfactory test is developed using the gpq idea. The proposed methods result in tests that are satisfactory in terms of type I error performance.
- Copyright
- © 2018, the Authors. Published by Atlantis Press.
- Open Access
- This is an open access article distributed under the CC BY-NC license (http://creativecommons.org/licenses/by-nc/4.0/).
Cite this article
TY - JOUR AU - Ginto Jacob Pottackal AU - Thomas Mathew PY - 2017 DA - 2017/12/01 TI - On the Assessment of Average Biosimilarity Based on a Three-Arm Parallel Design JO - Journal of Statistical Theory and Applications SP - 508 EP - 521 VL - 16 IS - 4 SN - 2214-1766 UR - https://doi.org/10.2991/jsta.2017.16.4.7 DO - 10.2991/jsta.2017.16.4.7 ID - Pottackal2017 ER -