ICH M10 guideline on bioanalytical method validation and study sample analysis


Aligning bioanalytical support of AAV therapies with regulatory guidance is crucial to ensure the safety, efficacy and quality of these gene therapies, providing a standardized framework for reliable data that supports regulatory approval and patient safety, yet lack of standardized compliance standards remains a significant challenge. 
This ICH M10 guideline provides recommendations for validating bioanalytical methods used to quantify chemical and biological drugs, ensuring data quality and consistency for regulatory decisions in drug development and market approval.

 

 

This resource is part of the Bioanalysis Zone Spotlight on bioanalytical support for AAV therapies. Click here to view the full feature.

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