- Recommendations for the design and optimization of immunoassays used in the detection of host antibodies against biotechnology productsAnthony R Mire-Sluis
Office of Biotechnology Products, Center for Drug Evaluation and Research, FDA, Rockville, MD 20852, USA
J Immunol Methods 289:1-16. 2004..Sections on assay performance parameters, including those that appear in regulatory guidances, are contained in this manuscript...
- Recommendations for the design, optimization, and qualification of cell-based assays used for the detection of neutralizing antibody responses elicited to biological therapeuticsShalini Gupta
Clinical Immunology, Amgen Inc, Thousand Oaks, CA 91320, USA
J Immunol Methods 321:1-18. 2007..This document provides scientific recommendations based on the experience of the authors for the development of cell-based assays for the detection of neutralizing antibodies in non-clinical and clinical studies...