Recommendations on risk-based strategies for detection and characterization of antibodies against biotechnology products.
作者： Eugen Koren , Holly W. Smith , Elizabeth Shores , Gopi Shankar , Deborah Finco-Kent
DOI: 10.1016/J.JIM.2008.01.001
关键词: Biotechnology 、 Antibody 、 Licensure 、 Biopharmaceutical industry 、 Adverse effect 、 Immunogenicity 、 Risk assessment 、 Antibody response 、 Efficacy 、 Medicine
摘要: The appropriate evaluation of the immunogenicity of biopharmaceuticals is of major importance for their successful development and licensure. Antibodies elicited by these products in …
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