Detection of Immune Complex Formation in Non-Clinical Studies and Implications for Clinical Risk Assessment
Steve J. Swanson, Ph.D., Executive Director, Medical Sciences, Clinical Immunology,
Fundamental Considerations for Defining “Comparable”
Therapeutic Monoclonal Antibodies
Paul Chamberlain, NDA Advisory Board
Immunogenicity Considerations in the Approval of Generic Enoxaparin in the US
Daniela Verthelyi, M.D., Ph.D., Chief, Immunology, Therapeutic Proteins, CDER/FDA
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