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Statistical Consideration of the Development of Biosimilar Products
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 Title & Authors
Statistical Consideration of the Development of Biosimilar Products
Kang, Seung-Ho; Nam, Ju-Sun;
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 Abstract
Recent assessments of the biosimilarity of biologic products have received considerable global attention. A clinical trial should be conducted to assess the biosimilarity of a biosimilar product and a innovator biological product. In this paper we will describe several methods for the implementation of clinical trials and statistical analysis, a real international case and related international guidelines.
 Keywords
Biological products;bioequivalence;equivalence trial;
 Language
Korean
 Cited by
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