Validation of immunoassays used to assess immunogenicity to therapeutic monoclonal antibodies-Reference-Cited by-同舟云学术

Validation of immunoassays used to assess immunogenicity to therapeutic monoclonal antibodies

Published:2005-09 Issue:3-4 Volume:39 Page:364-375
ISSN:0731-7085
Container-title:Journal of Pharmaceutical and Biomedical Analysis
language:en
Short-container-title:Journal of Pharmaceutical and Biomedical Analysis

Author:

Geng Dong,Shankar Gopi,Schantz Allen,Rajadhyaksha Manoj,Davis Hugh,Wagner Carrie

Publisher

Elsevier BV

Subject

Clinical Biochemistry,Spectroscopy,Drug Discovery,Pharmaceutical Science,Analytical Chemistry

Reference11 articles.

1. Immunogenicity of therapeutic proteins: Clinical implications and future prospects

2. Proceedings of the International Conference on Harmonization (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use: Tripartite Guideline, S6: Preclinical Safety Evaluation of Biotechnology-derived Pharmaceuticals, July1997 (available online at http://www.fda.gov/cder/guidance/index.htm).

3. Strategies for detection, measurement and characterization of unwanted antibodies induced by therapeutic biologicals

4. Recommendations for the design and optimization of immunoassays used in the detection of host antibodies against biotechnology products

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