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Immunogenicity assay development, validation and implementation /
In nine chapters from international experts, this book provides an excellent overview, with detailed summaries of advances in testing schemes, including critical topics on reagents used in assays, a summary of techniques used in overcoming assay interferences as well as considerations in statistical...
| Clasificación: | Libro Electrónico |
|---|---|
| Otros Autores: | , |
| Formato: | Electrónico eBook |
| Idioma: | Inglés |
| Publicado: |
London, England :
Future Science Ltd (Unitec House, 2 Albert Place, London N3 1QB, UK),
[2013]
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| Temas: | |
| Acceso en línea: | Texto completo |
Tabla de Contenidos:
- Immunogenicity assay development, validation and implementation / Robert Dodge & Renuka C. Pillutla
- Current regulatory guidelines for immunogenicity assays / Xiao-Yan Cai & Constance Cullen
- New technology and solutions in immunogenicity detection : case studies / Zhandong Don Zhong
- Critical comparison of cell-based assays and immunoassays for neutralizing antibody detection / Renuka C. Pillutla & Robert Dodge
- Drug-tolerant immunogenicity testing / Dharmesh D. Desai
- Good practices for statistical estimation of cut point / Zhandong Don Zhong & Lei Zhou
- Special challenges and considerations for developing assays for the detection of antidrug neutralizing antibodies / Mark A. Kroenke & Shalini Gupta
- Tiered approach to anti-drug antibody testing / Robert Dodge & Heather Myler
- Critical reagent stability for immunogenicity assays / Arron S.L. Xu & Jessica Weant
- Index.