目錄前言 1致謝 4術語表 5第1章 國家監管機構背景下的測試 71.1 初步考慮 81.2 如何使用數據 121.3 確認煙草制品測試范圍 171.4 待分析物 191.5 如何進行檢測 211.6 向監管機構提交數據 221.7 涉及的成本 241.8 實施 26第2章 建立檢測實驗室的三種可能路徑 272.1 承包外部檢測實驗室 282.2 利用現有的內部檢測實驗室 302.3 開發煙草專用檢測實驗室 31第3章 承包外部檢測實驗室 343.1 實驗室選擇標準 343.2 WHO 煙草實驗室網絡 413.3 協議和法律與倫理問題 443.4 樣本量估計 463.5 成本 473.6 案例研究:加拿大 483.7 循序漸進的過程 50第4章 利用現有的內部檢測實驗室 514.1 要求(實驗室設備、人員、總成本)——如何確定合適的實驗室 534.2 認證 554.3 案例研究:新加坡 564.4 循序漸進的過程 57第5章 開發煙草專用檢測實驗室 595.1 要求( 基礎設施、實驗室設備、人員、總成本) 595.2 信息技術系統 615.3 數據驗證 625.4 案例分析:CDC 635.5 循序漸進的過程 64第6章 資源:WHO TobLabNet 成員( 標準、優勢和程序) 66總結 69參考文獻 70附錄 實驗室內和實驗室間驗證 75A1.1 實驗室內方法驗證 75A1.2 實驗室間方法驗證 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