Implementation of highly sophisticated flow cytometry assays in multicenter clinical studies: considerations and guidance

摘要: Flow cytometry is increasingly becoming an important technology for biomarkers used in drug discovery and development. Within clinical development flow the determination of PD biomarkers, disease or efficacy patient stratification biomarkers. Significant differences exist between methodology other widely technologies measuring soluble including ligand binding mass spectrometry. These include very heavy reliance on aspects sample processing techniques as well stabilization to ensure viable samples. also require exploration new approaches wider discussion regarding method validation requirements. This paper provides a review current challenges, solutions, regulatory environment recommendations application measure