Sample Size for Biosimilar Trials: In Defense of Synthesis-Reference-Cited by-同舟云学术

Sample Size for Biosimilar Trials: In Defense of Synthesis

Published:2018-05 Issue:3 Volume:52 Page:300-305
ISSN:2168-4790
Container-title:Therapeutic Innovation & Regulatory Science
language:en
Short-container-title:Ther Innov Regul Sci

Author:

Clark Timothy,Jo Sook Jung,Phillips Alan

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Public Health, Environmental and Occupational Health,Pharmacology, Toxicology and Pharmaceutics (miscellaneous)

Link

http://link.springer.com/content/pdf/10.1177/2168479017729189.pdf

Reference26 articles.

1. EMA. Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues. EMEA/CHMP/BMWP/42832/2005 Rev. 1. July 1, 2015.

2. FDA. Guidance for industry. Scientific considerations in demonstrating biosimilarity to a reference product. April 2015.

3. Jones B, Jarvis P, Lewis JA, Ebbutt AF. Trials to assess equivalence: the importance of rigorous methods. BMJ. 1996;313:36–39.

4. Schumi J, Wittes J. Through the looking glass: understanding non-inferiority. Trials. 2011;12:106–117.

5. Rothmann M, Li N, Chen G, et al. Design and analysis of non-inferiority mortality trials in oncology. Stat Med. 2003; 22:239–264.

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