CLSI I/LA34

Design and Validation of Immunoassays for Assessment of Human Allergenicity of New Biotherapeutic Drugs, 1st Edition

This document provides 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.

This document is available in electronic format only.

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Chairholder: Robert G. Hamilton, PhD, D.ABMLI

Date of Publication: June 30, 2011

Order Code PDF: CLSI ILA34AE
ISBN Number: 1-56238-755-3

Order Code Print: print not available

Edition: First

Pages: 60

CLSI I/LA34 Additional Details

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This archived document is no longer being reviewed through the CLSI Consensus Document Development Process. However, this document is technically valid as of January 2017. Because of its value to the laboratory community, it is being retained in CLSI’s library.

CLSI I/LA34 Abstract

I/LA34-A | Design and Validation of Immunoassays for Assessment of Human Allergenicity of New Biotherapeutic Drugs, 1st Edition This document provides 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. This document is no longer being reviewed as part of our consensus process. However, because of its usefulness to a limited segment of the healthcare community, we are continuing to make the document available for its informational content. Chairholder: Robert G. Hamilton, PhD, D.ABMLI Organization: Johns Hopkins University School of Medicine Date of Publication: 06/30/2011 ISBN Number:1-56238-755-3 Edition: First Edition Pages: 60 Preview Sample Pages Nonmember Price: $140.00 Membership discount will be applied at checkout. This document is available in electronic format only.