Advanced search
Publication Cover
Journal of Biopharmaceutical Statistics Volume 27, 2017 - Issue 2: Special Issue on Biosimilarity Assessment, Guest Edited by Victoria Yu-Wei Chang and Laszlo Endrenyi
Submit an article Journal homepage
456
Views
4
CrossRef citations to date
0
Altmetric
Articles

Sample size requirement in analytical studies for similarity assessment

Shein-Chung ChowDepartment of Biostatistics and Bioinformatics, Duke University School of Medicine, Durham, North Carolina, USA
,
Fuyu SongCenter for Food and Drug Inspection, China Food and Drug Administration, Beijing, ChinaCorrespondence[email protected]
&
He BaiDepartment of Drug & Cosmetics Registration, China Food and Drug Administration, Beijing, China
Pages 233-238 | Received 06 Aug 2016, Accepted 16 Oct 2016, Published online: 11 Jan 2017

Citations (4)

Keep up to date with the latest research on this topic with citation updates for this article.

Subscribe to citation updates

Read on this site (1)

Lila Kashi, Katharina Yandrofski, Renae J. Preston, Luke W. Arbogast, John P. Giddens, John P. Marino, John E. Schiel & Zvi Kelman. (2018) Heterologous recombinant expression of non-originator NISTmAb. mAbs 10:6, pages 922-933.
Read now

Articles from other publishers (3)

Tianhua Wang, Yi Tsong & Meiyu Shen. 2019. Pharmaceutical Statistics. Pharmaceutical Statistics 27 43 .
Kejian Wu, Haitao Pan, Chen Li, Qingbo Zhao, Ling Wang & Jielai Xia. (2018) An evaluation roadmap for critical quality attributes from tier 1 in analytical similarity assessment. PLOS ONE 13:12, pages e0208354.
Crossref
Jennifer R. Brown, Florence Cymbalista, Jeff Sharman, Ira Jacobs, Pilar Nava-Parada & Anthony Mato. (2018) The Role of Rituximab in Chronic Lymphocytic Leukemia Treatment and the Potential Utility of Biosimilars. The Oncologist 23:3, pages 288-296.
Crossref

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Order Reprints Request Corporate Permissions

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

Request Academic Permissions

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.

Related research

People also read lists articles that other readers of this article have read.

Recommended articles lists articles that we recommend and is powered by our AI driven recommendation engine.

Cited by lists all citing articles based on Crossref citations.
Articles with the Crossref icon will open in a new tab.