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Statistical considerations for calculation of immunogenicity screening assay cut points

  • Published:2011-10 Issue:1-2 Volume:373 Page:200-208
  • ISSN:0022-1759
  • Container-title:Journal of Immunological Methods
  • language:en
  • Short-container-title:Journal of Immunological Methods

Author:

Hoffman David,Berger Marion

Publisher

Elsevier BV

Subject

Immunology,Immunology and Allergy

Reference17 articles.

1. Guideline on Immunogenicity of Biotechnology-derived Therapeutic Proteins;European Medicines Agency,2007

2. Concept Paper on Immunogenicity Assessment of Monoclonal Antibodies Intended for In Vivo Clinical Use;European Medicines Agency,2009

3. Draft Guidance for Industry: Bioanalytical Method Validation;Food and Drug Administration,1999

4. Guidance for Industry: Assay Development for Immunogenicity Testing of Therapeutic Proteins;Food and Drug Administration,2009

5. Antidrug antibody assay validation: industry survey results;Gorovits;AAPS J.,2009
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