Estimation and Approximation Approaches for Biosimilar Index Based on Reproducibility Probability-Reference-Cited by-同舟云学术

Estimation and Approximation Approaches for Biosimilar Index Based on Reproducibility Probability

Published:2014-10-31 Issue:6 Volume:24 Page:1298-1311
ISSN:1054-3406
Container-title:Journal of Biopharmaceutical Statistics
language:en
Short-container-title:Journal of Biopharmaceutical Statistics

Author:

Yang Lan-Yan¹²,Lai Chyong-Huey³

Affiliation:

1. Biostatistics and Informatics Unit, Clinical Trial Center, Chang Gung Memorial Hospital, Taoyuan, Taiwan

2. Gynecologic Cancer Research Center, Clinical Trial Center, Chang Gung Memorial Hospital, Taoyuan, Taiwan

3. Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, College of Medicine, Chang Gung Memorial Hospital and Chang Gung University, Taoyuan, Taiwan

Publisher

Informa UK Limited

Subject

Pharmacology (medical),Pharmacology,Statistics and Probability

Link

https://www.tandfonline.com/doi/pdf/10.1080/10543406.2014.941989

Reference26 articles.

1. Assessing biosimilarity and interchangeability of biosimilar products under the Biologics Price Competition and Innovation Act

2. Statistical Assessment of Biosimilar Products

3. A Comparison of Moment-Based and Probability-Based Criteria for Assessment of Follow-On Biologics

4. Scientific considerations for assessing biosimilar products

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1. The determination of biosimilarity margin and the assessment of biosimilarity for an (m+1)-arm parallel design;Communications in Statistics - Theory and Methods;2020-04-09

2. Reproducibility Probability Testing Kills P-value;SSRN Electronic Journal;2018

3. Adaptive Seamless Design for Establishing Pharmacokinetic and Efficacy Equivalence in Developing Biosimilars;Therapeutic Innovation & Regulatory Science;2017-11

4. Biosimilarity tetrahedron;Biosimilars and Interchangeable Biologics;2015-12-02

5. Statistical Assessment of Biosimilarity based on the Relative Distance between Follow-on Biologics in the (k+ 1)-Arm Parallel Design;Communications for Statistical Applications and Methods;2015-11-30