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Toxicological Evaluation of Electronic Nicotine Delivery Products /

Toxicological Evaluation of Electronic Nicotine Delivery Products (ENDP) discusses the scientific basis for the toxicological assessment and evaluation of ENDPs. The book covers aerosol chemistry, in vitro and in vivo studies as well as clinical studies. It provides the basis for the evaluation of s...

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Detalles Bibliográficos
Clasificación:Libro Electrónico
Otros Autores: Peitsch, Manuel C. (Editor ), Hoeng, Julia (Editor )
Formato: Electrónico eBook
Idioma:Inglés
Publicado: London ; San Diego, CA : Academic Press, an imprint of Elsevier, [2021]
Temas:
Acceso en línea:Texto completo
Tabla de Contenidos:
  • Front Cover
  • Toxicological Evaluation of Electronic Nicotine Delivery Products
  • Toxicological Evaluation of Electronic Nicotine Delivery Products
  • Copyright
  • List of Contributors
  • Acknowledgments
  • Preamble
  • Contents
  • 1
  • Tobacco Harm Reduction Concepts and Policy Approaches
  • 1.1 INTRODUCTION
  • 1.2 A CONTINUUM OF HARM
  • 1.3 THE ROLE OF HARM REDUCTION
  • 1.4 BENEFIT TO THE POPULATION AS A WHOLE
  • 1.5 PARAMETERS INFLUENCING HARM REDUCTION POLICIES
  • 1.5.1 Product Harm Reduction
  • 1.5.2 Product Acceptance and Usage
  • 1.5.2.1 Product acceptance
  • 1.5.2.2 Awareness
  • 1.5.2.3 Access
  • 1.5.2.4 Price
  • 1.5.2.5 Sales practices
  • 1.6 BALANCING RISK AND BENEFITS UNDER UNCERTAIN CONDITIONS
  • 1.6.1 Error Types in Hypothesis Testing
  • 1.6.2 Error Preference
  • 1.6.3 Reducing (and Accepting) Uncertainty
  • 1.7 EXAMPLES OF REGULATORY FRAMEWORKS
  • 1.7.1 Regulatory Objectives
  • 1.7.2 Ex Ante and Ex Post Regulation
  • 1.7.3 Product Bans
  • 1.7.4 Product Standards
  • 1.7.5 Consumer Access to Information
  • 1.8 THE ROLE OF TOBACCO COMPANIES
  • 1.9 CONCLUSION
  • REFERENCES
  • 2
  • Electronic Nicotine Delivery Products
  • 2.1 INTRODUCTION
  • 2.2 CONSUMER PRODUCTS THAT DELIVER NICOTINE
  • 2.3 THE RATIONALE FOR ENDP DEVELOPMENT
  • 2.4 BRIEF HISTORY OF PRODUCT DEVELOPMENT
  • 2.4.1 Electronic Cigarettes
  • 2.4.2 HTPs
  • 2.4.3 Hybrid E-cigarette Products
  • 2.5 CONCLUSIONS
  • REFERENCES
  • 3
  • Scientific Basis for Assessment of Electronic Nicotine Delivery Products
  • 3.1 INTRODUCTION
  • 3.2 ENDP ASSESSMENT FRAMEWORK
  • 3.2.1 First Principle: Epidemiology
  • 3.2.1.1 Effects of smoking cessation on disease risk
  • 3.2.2 Second Principle: Toxicology
  • 3.3 KEY SCIENTIFIC CHALLENGES IN ASSESSMENT OF ENDPS
  • 3.4 SYSTEMS TOXICOLOGY-BASED ASSESSMENT OF ENDPS
  • 3.4.1 Predictive Power of Systems Toxicology
  • 3.5 A COMPREHENSIVE ASSESSMENT PROGRAM FOR ENDPS
  • 3.5.1 Toxicological Assessment Steps
  • 3.5.1.1 Step I
  • 3.5.1.2 Step II
  • 3.5.1.3 Step III
  • 3.5.1.4 Step IV
  • 3.6 QUALITY CONSIDERATIONS
  • 3.6.1 Comparative Studies
  • 3.6.2 Exposure and its Verification
  • 3.6.2.1 Adequate exposure
  • 3.6.2.2 Exposure verification in nonclinical studies
  • 3.6.2.3 Exposure verification in clinical studies
  • 3.6.3 Independent Peer Review
  • 3.7 TRANSPARENT SHARING OF SCIENTIFIC DATA ON ENDP ASSESSMENT