Description: This presentation will focus on A CROs prospective on how context of use is critical for how best to perform Biomarker Fit for Purpose Validation Tiers for multiple bioanalytical platforms (LBA, PCR, LCMS, Hybrid LCMS and HRMS). Our experts will provide strategies and case studies of how the context of use of the biomarker dictates the fit for purpose validation tier and their recommendations for how they should be applied to various bioanalytical platforms.
Learning Objectives:
1. Translating the context of use into how to conduct the fit for purpose validation.
2. Helping to determine how to conduct a fit for purpose validation across a wide range of platforms
3. Discussing acceptable performance characteristics for various platforms with case studies.
