Anthony R Mire Sluis

Summary

Affiliation: Food and Drug Administration
Country: USA

Publications

  1. ncbi request reprint Recommendations for the design and optimization of immunoassays used in the detection of host antibodies against biotechnology products
    Anthony 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
  2. ncbi request reprint Recommendations for the design, optimization, and qualification of cell-based assays used for the detection of neutralizing antibody responses elicited to biological therapeutics
    Shalini Gupta
    Clinical Immunology, Amgen Inc, Thousand Oaks, CA 91320, USA
    J Immunol Methods 321:1-18. 2007

Collaborators

Detail Information

Publications2

  1. ncbi request reprint Recommendations for the design and optimization of immunoassays used in the detection of host antibodies against biotechnology products
    Anthony 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...
  2. ncbi request reprint Recommendations for the design, optimization, and qualification of cell-based assays used for the detection of neutralizing antibody responses elicited to biological therapeutics
    Shalini 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...