An evaluation roadmap for critical quality attributes from tier 1 in analytical similarity assessment-Reference-Cited by-同舟云学术

An evaluation roadmap for critical quality attributes from tier 1 in analytical similarity assessment

Published:2018-12-06 Issue:12 Volume:13 Page:e0208354
ISSN:1932-6203
Container-title:PLOS ONE
language:en
Short-container-title:PLoS ONE

Author:

Wu Kejian,Pan Haitao,Li Chen,Zhao Qingbo,Wang Ling,Xia Jielai^ORCID

Funder

National major scientific and technological special project for significant new drugs development of China

National Natural Science Foundation of China

American Lebanese Syrian Associated Charities

Publisher

Public Library of Science (PLoS)

Subject

Multidisciplinary

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5. Scientific considerations in demonstrating biosimilarity to a reference product. Food and Drug Administration. 2015. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM291128.pdf

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