Article ID Journal Published Year Pages File Type
10852752 Biologicals 2011 4 Pages PDF
Abstract
Even though there seem to be differences in data requirements by each national regulatory authority, the accumulation of experience will provide the rationale and consensus on how to design the clinical trials for follow-on biologics.
Keywords
Related Topics
Life Sciences Biochemistry, Genetics and Molecular Biology Biochemistry, Genetics and Molecular Biology (General)
Preview
Experience of reviewing the follow-on biologics including Somatropin and erythropoietin in Japan
Authors
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