BOB: Bayesian optimal design for biosimilar trials with co‐primary endpoints-Reference-Cited by-同舟云学术

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BOB: Bayesian optimal design for biosimilar trials with co‐primary endpoints

Published:2022-09-20 Issue:26 Volume:41 Page:5319-5334
ISSN:0277-6715
Container-title:Statistics in Medicine
language:en
Short-container-title:Statistics in Medicine

Author:

Chi Xiaohan¹,Yu Zhangsheng²³^ORCID,Lin Ruitao¹^ORCID

Affiliation:

1. Department of Biostatistics The University of Texas MD Anderson Cancer Center Houston Texas USA

2. Department of Bioinformatics and Biostatistics, School of Life Sciences and Biotechnology Shanghai Jiao Tong University Shanghai China

3. SJTU‐Yale Joint Center for Biostatistics and Data Science Shanghai Jiao Tong University Shanghai China

Funder

National Cancer Institute

Publisher

Wiley

Subject

Statistics and Probability,Epidemiology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/sim.9571

Reference31 articles.

2. Safety of Biologics, Including Biosimilars: Perspectives on Current Status and Future Direction

3. U. S. Food and Drug Administration (FDA).Guidance for industry: scientific considerations in demonstrating biosimilarity to a reference product; April 2015.https://www.fda.gov/media/82647/download. Accessed June 16 2022.

4. Update on Biosimilars in Asia

5. European Medicines Agency (EMA).Guideline on similar biological medicinal products containing biotechnology‐derived proteins as active substance: non‐clinical and clinical issues; January 9 2015.https://www.ema.europa.eu/en/similar‐biological‐medicinal‐products‐containing‐biotechnology‐derived‐proteins‐active‐substance‐non. Accessed June 16 2022.

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