Reviews: Qualification of Biomarker: Total Kidney Volume in Studies for Treatment of Autosomal Dominant Polycystic Kidney Disease

• Executive Summary: Biomarker Qualification Review for Total Kidney Volume (PDF - 413KB)
• Biomarker Qualification Review Team for Total Kidney Volume (TKV) (CDRH Consulting Review) (PDF - 436KB)
• Clinical Review of PKD Outcomes Consortium biomarker qualification submission (Division of Cardiovascular and Renal Products (PDF - 756KB)
• Statistical Review and Evaluation: Biomarker Qualification Total Kidney Volume (TKV) (PDF - 1,324KB)
• Secondary Statistical Review: Total Kidney Volume (TKV) (PDF - 350KB)