Bridging Bioanalysis & Biomarker Analysis in Drug Development & Clinical Diagnosis: Regulatory Considerations & Technology Advancement
Time: 10:45 am
day: Day Three Track A
Details:
- The similarities and differences in regulatory requirements (1) for bioanalysis and biomarker analysis and (2) in drug development and clinical diagnosis
- The challenges and impact to biomarker testing resulted from the different concepts and practices of GCLP/BAV vs. CLIA-ISO/CLSI guidance for clinical biomarker analysis
- Advancement of immunoassay and chromatography-mass spectrometry assays for clinical biomarker analysis
