Clinical Evaluation of Immunoassays, 2nd Edition
This document addresses the need for clinical evaluation of new immunoassays and new applications of existing assays, as well as multiple assay formats and their uses. As a guide to designing and executing a clinical evaluation, this document will aid developers of "in-house" assays for institutional use, developers of assays used for monitoring pharmacologic effects of new drugs or biologics, and clinical and regulatory personnel responsible for commercializing products.
This document is available in electronic format only.
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Chairholder: Marilyn M. Lightfoote, MD, PhD
Date of Publication: August 29, 2008
ISBN Number: 1-56238-674-3
Order Code PDF: ILA21A2E
Order Code Print: print not available
I/LA21 Additional Details
The U.S. Food and Drug Administration (FDA) has evaluated and recognized this approved-level consensus standard for use in satisfying a regulatory requirement.
This archived document is no longer being reviewed through the CLSI Consensus Document Development Process. However, this document is technically valid as of September 2017. Because of its value to the laboratory community, it is being retained in CLSI’s library.