Validation of Cell-Based Assays in the GLP Setting will provide the professional with an invaluable reference source, featuring key guidelines, and will prove extremely useful to all scientists working in the areas of drug development.

In Validation of Cell-Based Assays in the GLP Setting, the editors have collected assays for which validation procedures have been developed, making this a vital purchase for anyone using such assays in drug development.

Contents

1. Considerations While Setting up Cell-Based Assays
2. Development, Optimization and Validation of Cell-Based Assays - 1
3. Development, Optimization and Validation of Cell-Based Assays - 2
4. Whole Blood ex vivo Stimulation Assay Development, Optimization and Validation
5. Immunohistochemistry Assays in Good Laboratory Practice Studies
6. Flow Cytometric Cell-Based Assays: An Overview of General Applications
7. T-Cell Surface Markers in Human Peripheral Whole Blood Using Flow Cytometry
8. Intracellular Cytokine Detection by Flow Cytometry
9. Validating Reference Samples for Comparison in a Regulated ELISPOT Assay
10. IFN-γ ELISPOT Assay Validation
11. IFN-5 ELISPOT Assay Validation
12. Validation of the Cylex Technology to Measure T and B Cell Activation Capacity in Clinical Trials
13. Development of Validated Neutralization Bioassays
14. Endpoint Assays in HIV-1 Vaccine Trials: Functioning in a Good Laboratory Practices Environment
15. The Future Direction of Cell-Based Assays

Index

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