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Reportlinker Adds Immunogenicity to Biologics
Date:11/3/2010

e collected for immunogenicity assessments? 4.10. Reporting of clinical immunogenicity results

5. Post-marketing immunogenicity commitments

6. References

Chapter 6 Regulatory Recommendations when dealing with the FDA

Dr Bonita Rup, Senior Director, Bioanalytical R&D, Drug Safety and Metabolism, Wyeth Research, USA

1. Recent White Papers on development, validation and implementation of immunogenicity testing and on risk assessment 1.1. Background to the papers, why produced, which companies and people made recommendations, their significance to the industry. 1.2. Recommendations for the design and optimisation of immunoassays 1.3. Report on neutralising antibody white paper 1.4. What is the benefit of the FDA-requirement for neutralising assays in phase II (they are difficult to develop and are only relevant at phase III) 1.5. Report on validation of immunoassays 1.6. Report on risk based strategies 1.7. Advice on methods to use for specific products 1.8. Sensitivity of screening assays 1.9. Dealing with low-affinity antibodies 1.10. Evaluation of drug interference 1.11. Confirmatory assays required: how effective are they as a predictive marker? 1.12. Immunogenicity method validation 1.13. Interpretation of the results: How do they correlate with the clinical outcome? 1.14. Assays for T-cell activation

2. Practical advice on dealing with the regulators at the various stages of development 2.1. Experiences of the industry 2.2. When to design the immunogenicity programme 2.3. Advice on selection of assays for the type of product 2.4. Acceptable levels of assay sensitivity 2.5. Ensuring assay results are not questionable 2.6. Proper validation and characterisation of assays 2.7. Requirements before going into patients 2.8. Validation for each stage 2.9. Amount of pre-clinical and clinical immunogenicity data required 2.10. Advice on dealing with impurities with host cell protein 2.11. How much information is enough an
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