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Operational Challenges for Biosimilar Studies.

Authors :
Gorham, Hazel
Challand, Rodeina
Source :
Applied Clinical Trials. Oct/Nov2016, Vol. 25 Issue 10/11, p44-49. 6p.
Publication Year :
2016

Abstract

The article discusses on the operational challenges faced by biosimilar development. Topics mentioned include the specific regulatory requirements, the lack of understanding on the biosimilarity concept among patients and physicians, and the difficulty in obtaining certificate of analysis (CoA) for commercial reference product supplies.

Subjects

Subjects :
*SIMILARITY (Physics)
*BIOLOGICAL research
*THEORY of knowledge
*CONCEPT engineering
*REGULATORY approval
*GOVERNMENT policy

Details

Language :
English
ISSN :
10648542
Volume :
25
Issue :
10/11
Database :
Academic Search Index
Journal :
Applied Clinical Trials
Publication Type :
Academic Journal
Accession number :
119049225

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