Document Detail


Estimation and approximation approaches for biosimilar index based on reproducibility probability.
MedLine Citation:
PMID:  25033191     Owner:  NLM     Status:  Publisher    
Abstract/OtherAbstract:
Abstract In recent years, quantitative evaluation for biosimilarity has been taken seriously due to the development of biosimilar products. The concept for assessment of biological products is very different form that of small molecule drug products since the variability in respect to the manufacturing process and environmental factors of the biological products. In this paper, we proposed an estimate method for biosimilar index and the related lower bound based on the concept of reproducibility probability by assessing power. In addition, some approximations are proposed and compared in regard to simplicity and accuracy.
Authors:
Lan-Yan Yang; Chyong-Huey Lai
Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2014-7-17
Journal Detail:
Title:  Journal of biopharmaceutical statistics     Volume:  -     ISSN:  1520-5711     ISO Abbreviation:  J Biopharm Stat     Publication Date:  2014 Jul 
Date Detail:
Created Date:  2014-7-17     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  9200436     Medline TA:  J Biopharm Stat     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
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