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大家好,我叫 Barbara O’Neill,是质量标准的高级经理。我的工作经历包括参加临床 试验和代表制药公司进行稽查,今天讲课的内容是对临床试验单位的稽查。 在今天的课程中,我们主要讲的内容是:稽查的定义,FDA 视察, 申办者稽查以及视 察和稽查中常见的问题。ICH-GCP 对稽查的定义如下:稽查是对试验相关的活动和文件进 行系统的、独立的检查,以确定这些试验相关的活动和数据的记录、分析和准确的报告是否 与试验方案、申办者的标准操作规程、GCP 以及相关的法规要求相符
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N-methylcarbamate insecticide residues, including carbamate metabolites, are ex￾tracted with methanol. The extract is cleaned up by partitioning and column chromatography on a charcoal/Celite column. Residues are selectively determined
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PERCENTAGE FAT, WATER, AND SUGARS IN FOODS Methods in Chapters 3 and 4 are usually designated as applicable to either fatty
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1 Codes: C: complete (>80%); P: partial (50-80%); S: small (<50%); V: variable (approximate percentage when known); R: recovered but no quantitative information available; NR: not recovered
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Use of any multiresidue method (MRM) is supported by available information about how potential residues behave through the steps of the method. To provide that support for PAM I MRMs, additional chemicals are continually tested through the method steps and the resulting data compiled in a single database. All PAM
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Multiresidue methodology by definition requires determinative steps capable of separating analytes from one another so each can be detected and measured individually. Both gas-liquid chromatography (GLC) and high performance liquid
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In recent years, high performance liquid chromatography (HPLC) has grown in popularity as a determinative step for residue analysis, until today it is accepted as complementary to the more traditional gas liquid
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美国植物药新药指南_评美国FDA的《植物药研制指导原则》
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10.1 Federal Regulation of Medical Devices 10.1.1 The Law (including amendments) 10.1.2 Organization of FDA 10.1.3 Classification of Devices 10.1.4 Process of Assessment 10.1.4.1 510(k)Substantial Equivalence 10.1.4.2 Premarket Approval 10.1.5 Clinical Trials (Investigational Device Exemption) 10.1.6 Labeling 10.1.7 Tripartite Biocompatibility Guidance 10.1.8 Standards 10.1.9 Good Manufacturing Procedures 10.1.10 Good Laboratory Practices 10.2 Clinical Trial Design
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