Best Practices in Novel Biomarker Assay Fit-for-Purpose Testing

BEST PRACTICES IN NOVEL BIOMARKER ASSAY FIT-FOR-PURPOSE TESTING 

Validation is performed to demonstrate that an assay or method is suitable and reliable for its intended use. Defined validation requirements are specified in the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use 

Collaborative efforts to establish standardized and harmonized validation practices across industry are needed to 

Drug Discovery Toxicology From Target Assessment to Translational Biomarkers, First Edition. Edited by Yvonne Will, J. Eric McDuffie, Andrew J. Olaharski, and Brandon D. Jeffy. 

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