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DESIGN AND VALIDATION OF IMMUNOASSAYS FOR ASSESSMENT OF HUMAN ALLERGENICITY OF NEW BIOTHERAPEUTIC DRUGS
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Available format(s): Hardcopy
Withdrawn date: 30-06-2011
Language(s): English
Published date: 30-06-2011
Publisher: Clinical Laboratory Standards Institute
AbstractCommittee MembershipForeword1 Scope2 Introduction3 Standard Precautions4 Terminology5 Biochemical and Clinical Properties of IgE6 Utility of IgE in Clinical Studies of Drug Safety and Efficacy7 Specimens8 Assay Protocols9 Qualification of Assay Reagents10 Validation and Testing Strategy11 Assay Interference12 Recommendations for Drug Manufacturers13 Recommendations for Academic Centers and Practitioners Monitoring Immunogenicity in Clinical Trials14 Recommendations for RegulatorsReferencesAppendix A - Drug Allergen Specificities Available for IgE Antibody Testing in Commercial AssaysAppendix B - Protocol for Depletion of IgE and IgM Antibodies From Human SerumAppendix C - Illustrative Protocol Enzyme-Linked Immunosorbent Assay for IgE Antidrug Detection in Human SerumThe Quality Management System ApproachRelated CLSI Reference Materials
Gives guidance for the design, validation, analytical performance, and quality assurance of laboratory assays used in the measurement of human immunoglobulin E antibodies specific for new biotherapeutic drugs.
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