Statistical approaches for the determination of cut points in anti-drug antibody bioassays-Reference-Cited by-同舟云学术

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Statistical approaches for the determination of cut points in anti-drug antibody bioassays

Published:2015-03 Issue: Volume:418 Page:84-100
ISSN:0022-1759
Container-title:Journal of Immunological Methods
language:en
Short-container-title:Journal of Immunological Methods

Author:

Schaarschmidt Frank,Hofmann Matthias,Jaki Thomas,Grün Bettina,Hothorn Ludwig A.

Publisher

Elsevier BV

Subject

Immunology,Immunology and Allergy

Reference31 articles.

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2. Guidance for industry;Center for Drug Evaluation and Research,2009

3. Regarding confirmatory immunogenicity assays;Coleman;J. Pharm. Biomed. Anal.,2013

4. Guideline on Immunogenicity Assessment of Biotechnology Derived Therapeutic Proteins;Committee for Medicinal Products for Human Use,2007

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