Neutralizing Antibody Sample Testing and Report Harmonization
The Critical Need for Reporting Harmonization
A clear scientific and operational need exists for harmonized bioanalytical neutralizing antibody study reporting. Standardizing this process facilitates clearer communication of findings and supports expedient review by both industry and health authorities.
To address key gaps in bioanalytical reporting, a cross-industry group of NAb assay experts established harmonized recommendations. This white paper provides these recommendations and a submission template to streamline agency filings for neutralizing antibody assays.
What You Will Learn
This white paper delivers expert recommendations and a structured template for reporting clinical neutralizing antibody (NAb) results, focusing on essential bioanalytical report (BAR) elements.
Key Learnings:
- Essential Bioanalytical Report (BAR) Elements: Gain comprehensive understanding of critical components for your BAR, including method validation, critical reagents and equipment, data analysis protocols, study samples, and results presentation.
- Cross-Industry Expert Recommendations: Access insights from leading NAb assay experts across pharmaceutical companies and regulatory agencies on best practices for documenting and presenting neutralizing antibody results.
- Submission-Ready Template: Utilize a harmonized structure for the NAb BAR designed to streamline regulatory filings, improve clarity, and facilitate efficient agency review.
- Standardized Content Framework: Learn how to structure your reports to address key bioanalytical reporting gaps while ensuring consistent communication across the industry.
Note: This publication focuses specifically on the content and presentation of neutralizing antibody sample analysis reports. The interpretation of immunogenicity data, including evaluation of NAb impact on safety, exposure, and efficacy, is outside the scope of this document.
Secure Your Complimentary White Paper Today
Access expert guidance from a cross-industry team and a practical editable template to enhance the clarity and efficiency of your neutralizing antibody assay reporting.