目录前言 1致谢 4术语表 5第1章 国家监管机构背景下的测试 71.1 初步考虑 81.2 如何使用数据 121.3 确认烟草制品测试范围 171.4 待分析物 191.5 如何进行检测 211.6 向监管机构提交数据 221.7 涉及的成本 241.8 实施 26第2章 建立检测实验室的三种可能路径 272.1 承包外部检测实验室 282.2 利用现有的内部检测实验室 302.3 开发烟草专用检测实验室 31第3章 承包外部检测实验室 343.1 实验室选择标准 343.2 WHO 烟草实验室网络 413.3 协议和法律与伦理问题 443.4 样本量估计 463.5 成本 473.6 案例研究:加拿大 483.7 循序渐进的过程 50第4章 利用现有的内部检测实验室 514.1 要求(实验室设备、人员、总成本)——如何确定合适的实验室 534.2 认证 554.3 案例研究:新加坡 564.4 循序渐进的过程 57第5章 开发烟草专用检测实验室 595.1 要求( 基础设施、实验室设备、人员、总成本) 595.2 信息技术系统 615.3 数据验证 625.4 案例分析:CDC 635.5 循序渐进的过程 64第6章 资源:WHO TobLabNet 成员( 标准、优势和程序) 66总结 69参考文献 70附录 实验室内和实验室间验证 75A1.1 实验室内方法验证 75A1.2 实验室间方法验证 77ContentsPreface 79Acknowledgements 82Glossary 83Chapter 1 Testing in the Context of a Country's Regulatory Authority 851.1 Initial considerations 861.2 How data can be used 911.3 Identifying tobacco products to test 971.4 Analytes to test 1001.5 How the tests are to be conducted 1021.6 Communicating data to regulators 1041.7 Covering costs 1071.8 Implementation 109Chapter 2 Introduction to Three Possible Routes to a Testing Laboratory 1102.1 Contracting with an external laboratory 1112.2 Using an existing internal laboratory 1132.3 Developing a dedicated laboratory 115Chapter 3 Contracting with an External Testing Laboratory 1193.1 Laboratory selection criteria 1193.2 WHO TobLabNet 1273.3 Agreements and legal/ethical issues 1313.4 Sample load estimates 1353.5 Costs 1363.6 Case study – Canada 1373.7 Step-by-step process 139Chapter 4 Using an Existing Internal Testing Laboratory 1404.1 Requirements (laboratory equipment, staff, overall cost) – how to identify the right laboratory 1434.2 Accreditation 1464.3 Case study – Singapore 1474.4 Step-by-step process 147Chapter 5 Developing a Tobacco-exclusive Testing Laboratory 1495.1 Requirements (infrastructure, laboratory equipment, staff, overall cost) 1495.2 Information technology (IT) systems 1525.3 Data verification 1535.4 Case study–CDC 1545.5 Step-by-step process 156Chapter 6 Resources: WHO TobLabNet Membership (criteria, advantages, and procedures) 158Summary 163References 165Appendix 1. Intra- and Inter-laboratory Validation 169A1.1 Intra-laboratory method validation 169A1.2 Inter-laboratory method validation 171References 172