Bioanalytical method validation

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 andResearch (CDER) 5600 Fishers Lane, Rockville, MD 20857 (Tel) 301-827-4573 Internet at http://www.fda.gov/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 http://www.fda.gov/cvm

U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation andResearch (CDER) Center for Veterinary Medicine (CVM) May 2001 BP

Table of Contents

I. II. A. B. C. III. IV. A. B. C. D. E. F. V. A. B. VI.

INTRODUCTION..................................................................................................................................................................1BACKGROUND....................................................................................................................................................................1 FULL VALIDATION .............................................................................................................................................................. 2 PARTIAL VALIDATION........................................................................................................................................................ 2 CROSS-VALIDATION ........................................................................................................................................................... 3 REFERENCE STANDARD.............................................................................................................................................4 METHODDEVELOPMENT: CHEMICAL ASSAY........................................................................................................4 SELECTIVITY....................................................................................................................................................................... 4 ACCURACY, PRECISION, AND RECOVERY......................................................................................................................... 5 CALIBRATION/STANDARD CURVE...................................................................................................................................... 5STABILITY........................................................................................................................................................................... 6 PRINCIPLES OF BIOANALYTICAL M ETHOD VALIDATION AND ESTABLISHMENT ............................................................ 8 SPECIFIC RECOMMENDATIONS FOR M ETHOD VALIDATION ........................................................................................... 10 METHOD DEVELOPMENT: MICROBIOLOGICAL AND LIGAND-BINDING ASSAYS ..................................11 SELECTIVITY ISSUES........................................................................................................................................................ 11 QUANTIFICATION ISSUES ................................................................................................................................................. 12 APPLICATION OF VALIDATED METHOD TO ROUTINE DRUGANALYSIS....................................................13 ACCEPTANCE CRITERIA FOR THE RUN...................................................................................................................................... 15

VII. A. B. C. D.

DOCUMENTATION......................................................................................................................................................16...