A modified Wald test for reference scaled assessment of analytical equivalence
Author:
Affiliation:
1. Division of Biometrics VI, Office of Biostatistics, CDER, FDA, Maryland, USA
Publisher
Informa UK Limited
Subject
Pharmacology (medical),Pharmacology,Statistics and Probability
Link
https://www.tandfonline.com/doi/pdf/10.1080/10543406.2019.1584206
Reference13 articles.
1. Ahn, S., and J. A. Fessler. 2003. Standard errors of mean, variance, and standard deviation estimators, 1–2. EECS Department, the University of Michigan. https://web.eecs.umich.edu/~fessler/papers/files/tr/stderr.pdf
2. Statistical Approaches to Assess Biosimilarity from Analytical Data
3. Wald tests for variance-adjusted equivalence assessment with normal endpoints
4. Exact test-based approach for equivalence test with parameter margin
5. Adjustment for unbalanced sample size for analytical biosimilar equivalence assessment
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