Franklin

Toxicological Evaluation of Electronic Nicotine Delivery Products / edited by Manuel C. Peitsch, Julia Hoeng.

Publication:
London ; San Diego, CA : Academic Press, an imprint of Elsevier, [2021]
Format/Description:
Book
1 online resource
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Subjects:
Nicotine -- Toxicology.
Tobacco -- Toxicology.
Electronic cigarettes -- Safety measures.
Contents:
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
Notes:
Electronic reproduction. Amsterdam Available via World Wide Web.
Description based on online resource; title from digital title page (viewed on March 24, 2021).
Contributor:
Peitsch, Manuel C., editor.
Hoeng, Julia, editor.
ScienceDirect (Online service)
Other format:
Print version:
Print version:
ISBN:
9780128209356
0128209356
9780128204900
0128204907
Publisher Number:
99986861491
Access Restriction:
Restricted for use by site license.