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CLSI I/LA34 A : 1ED 2011

Withdrawn

Withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

DESIGN AND VALIDATION OF IMMUNOASSAYS FOR ASSESSMENT OF HUMAN ALLERGENICITY OF NEW BIOTHERAPEUTIC DRUGS

Available format(s)

Hardcopy

Withdrawn date

30-06-2011

Language(s)

English

Published date

30-06-2011

€403.79
Excluding VAT

Abstract
Committee Membership
Foreword
1 Scope
2 Introduction
3 Standard Precautions
4 Terminology
5 Biochemical and Clinical Properties of IgE
6 Utility of IgE in Clinical Studies of Drug
   Safety and Efficacy
7 Specimens
8 Assay Protocols
9 Qualification of Assay Reagents
10 Validation and Testing Strategy
11 Assay Interference
12 Recommendations for Drug Manufacturers
13 Recommendations for Academic Centers
   and Practitioners Monitoring Immunogenicity
   in Clinical Trials
14 Recommendations for Regulators
References
Appendix A - Drug Allergen Specificities Available
             for IgE Antibody Testing in Commercial Assays
Appendix B - Protocol for Depletion of IgE and IgM
             Antibodies From Human Serum
Appendix C - Illustrative Protocol Enzyme-Linked
             Immunosorbent Assay for IgE Antidrug Detection
             in Human Serum
The Quality Management System Approach
Related 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.

DevelopmentNote
Supersedes NCCLS I/LA34 P. (07/2011)
DocumentType
Miscellaneous Product
ISBN
1-56238-755-3
Pages
60
PublisherName
Clinical Laboratory Standards Institute
Status
Withdrawn
Supersedes

CLSI I/LA20 A2 : 2ED 2009 ANALYTICAL PERFORMANCE CHARACTERISTICS AND CLINICAL UTILITY OF IMMUNOLOGICAL ASSAYS FOR HUMAN IMMUNOGLOBULIN E (IGE) ANTIBODIES AND DEFINED ALLERGEN SPECIFICITIES
CLSI M29 A3 : 3ED 2005 ACQUIRED INFECTIONS; APPROVED GUIDELINE
CLSI EP17 A : 1ED 2004 PROTOCOLS FOR DETERMINATION OF LIMITS OF DETECTION AND LIMITS OF QUANTITATION
CLSI EP7 A2 : 2ED 2005 INTERFERENCE TESTING IN CLINICAL CHEMISTRY

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