生物样品分析方法验证指导 英文.docVIP

Guidance for IndustryBioanalytical Methods Validation for Human Studies DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Comments and suggestions regarding this draft document should be submitted within 60 days ofpublication in the Federal Register of the notice announcing the availability of the draft guidance. Submit comments to Documents Management Branch (HFA-305, Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should beidentified with the docket number listed in the notice of availability that publishes in the Federal Register . For questions on the content of the draft document contact Vinod Shah, (301 594-5635. U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER December 1998 BP # j:\!guidance\2578dft.wpd 12/14/98 Guidance for IndustryBioanalytical Methods Validation for Human Studies 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 U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER December 1998 BP # j:\!guidance\2578dft.wpd 12/14/98 Draft — Not for Implementation Table of Contents I. INTRODUCTION. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 II. BACKGROUND. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 III. REFERENCE STANDARD. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 IV. PRE-STUDY VALIDATION. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 A. Specificity. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 B. Calibration Curve. .