ELISA实验基础知识培训.pptVIP

目录 国际法规对生物分析方法验证的要求 双抗夹心ELISA检验方法实例和验证介绍 ELISA分析模型的选择 Guidance for Industry Bioanalytical Method Validation U.S. Department of Health and Human Services Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) Center for Veterinary Medicine (CVM) May 2001 FDA对生物分析方法验证的要求 Typical method development and establishment for a bioanalytical method include determination of (1)selectivity, (2) accuracy, precision, recovery, (3) calibration curve, and (4) stability of analyte in spiked samples 生物学分析方法的验证项目包括：（1）