CLSI I/LA34 P : 1ED 2010
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
DESIGN AND VALIDATION OF IMMUNOASSAYS FOR ASSESSMENT OF HUMAN ALLERGENICITY OF NEW BIOTHERAPEUTIC DRUGS
30-06-2011
12-01-2013
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 Manufactures
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 - Worksheet 1: Procedure Checklist
Appendix C - Worksheet 2: ELISA Plate Setup(s) for
Drug-Specific IgE Assay - Screening
Appendix D - Worksheet 3: ELISA Plate Setup(s) for
Drug-Specific IgE Assay - Confirmatory
Appendix E - Worksheet 4: ELISA Plate Setup(s) for
Drug-Specific IgE Assay - End-point Titer
Appendix F - Protocol for Depletion of IgE Antibodies
From Human Serum
Appendix G - Illustrative Protocol ELISA for IgE Antidrug
Detection in Human Serum
The Quality Management System Approach
Related CLSI Reference Materials
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