CLSI I/LA34 A : 1ED 2011
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.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
Hardcopy
06-30-2011
English
06-30-2011
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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Withdrawn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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