分析方法验证指导原则-FDA.pdf

Guidance for Industry Bioanalytical Method Validation U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Veterinary Medicine (CVM) May 2001 BP Guidance for Industry Bioanalytical Method Validation Additional copies are available from: Drug Information Branch (HFD-210) Center for Drug Evaluation and Research (CDER) 5600 Fishers Lane, Rockville, MD 20857 (Tel) 301-827-4573 Internet at /cder/guidance/index.htm or Communications Staff (HFV-12) Center for Veterinary Medicine (CVM) 7500 Standish Place, Rockville, MD 20855 (Tel) 301–594-1755 Internet at /cvm U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Veterinary Medicine (CVM) May 2001 BP Table of Contents I. INTRODUCTION1 II. BACKGROUND1 A. FULL VALIDATION 2 B. PARTIAL VALIDATION 2 C. CROSS-VALIDATION 3 III. REFERENCE STANDARD4 IV. METHOD DEVELOPMENT: CHEMICAL ASSAY4 A. SELECTIVITY 4 B. ACCURACY, PRECISION, AND RECOVERY 5 C. CALIBRATION/STANDARD CURVE 5 D. STABILITY 6 E. PRINCI