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: ILA34AE
ISBN Number: 1-56238-755-3
Order Code Print: print not available
Edition: First
Pages: 60
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.