CLSI I/LA34-A

Clinical and Laboratory Standards Institute document I/LA34-A–Design and Validation of Immunoassays for Assessment ofHuman Allergenicity of New Biotherapeutic Drugs; Approved Guideline provides a framework for the design and validation of aqualitative immunoassay that detects human immunoglobulin E (IgE) antibody to new drugs in various body fluids and tissueextracts. It addresses technical challenges that are uniquely associated with the development of an assay that detects drug-specificIgE antibody in human blood and tissue extracts. It provides an approach for validation of an assay in the absence of a positivedrug-specific human IgE antibody serum, which involves a feasibility study phase and then development and validation, using aconcomitantly established drug-specific human immunoglobulin G antibody assay as part of its quality control program. Thisguideline is intended for use by clinical and laboratory investigators who are involved in generating preclinical data andperforming clinical trials involving new biotherapeutic drugs. It is also intended as a guideline for administrators of manufacturersafety programs, and government regulators who are required to critique IgE antibody assay methods and assess the validity ofallergenicity data that have been submitted by innovator pharmaceutical investigators as part of a governmental licensing processfor a new drug.

Published:

06/01/2011

ISBN(s):

1562387553

Number of Pages:

64