Comparing the preclinical risk profile of inhalable candidate and potential candidate modified risk tobacco products: A bridging use case

[1]  M. Peitsch,et al.  Structural, functional, and molecular impact on the cardiovascular system in ApoE-/- mice exposed to aerosol from candidate modified risk tobacco products, Carbon Heated Tobacco Product 1.2 and Tobacco Heating System 2.2, compared with cigarette smoke. , 2019, Chemico-biological interactions.

[2]  M. Peitsch,et al.  A six-month systems toxicology inhalation/cessation study in ApoE-/- mice to investigate cardiovascular and respiratory exposure effects of modified risk tobacco products, CHTP 1.2 and THS 2.2, compared with conventional cigarettes. , 2019, Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association.

[3]  L. Haws,et al.  A Framework for Systematic Evaluation and Quantitative Integration of Mechanistic Data in Assessments of Potential Human Carcinogens , 2018, Toxicological sciences : an official journal of the Society of Toxicology.

[4]  R. Weitkunat,et al.  Estimating the population health impact of introducing a reduced‐risk tobacco product into Japan. The effect of differing assumptions, and some comparisons with the U.S. , 2018, Regulatory toxicology and pharmacology : RTP.

[5]  Rémi H. J. Dulize,et al.  In vitro systems toxicology-based assessment of the potential modified risk tobacco product CHTP 1.2 for vascular inflammation- and cytotoxicity-associated mechanisms promoting adhesion of monocytic cells to human coronary arterial endothelial cells. , 2018, Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association.

[6]  David Allen,et al.  Pathway-based predictive approaches for non-animal assessment of acute inhalation toxicity. , 2018, Toxicology in vitro : an international journal published in association with BIBRA.

[7]  Dai Yuki,et al.  Assessment of the exposure to harmful and potentially harmful constituents in healthy Japanese smokers using a novel tobacco vapor product compared with conventional cigarettes and smoking abstinence , 2018, Regulatory toxicology and pharmacology : RTP.

[8]  Nathan Gale,et al.  Changes in Biomarkers of Exposure on Switching From a Conventional Cigarette to Tobacco Heating Products: A Randomized, Controlled Study in Healthy Japanese Subjects , 2018, Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco.

[9]  R. Weitkunat,et al.  Modeling the Population Health Impact of Introducing a Modified Risk Tobacco Product into the U.S. Market , 2018, Healthcare.

[10]  Rémi H. J. Dulize,et al.  A 90-day OECD TG 413 rat inhalation study with systems toxicology endpoints demonstrates reduced exposure effects of the aerosol from the carbon heated tobacco product version 1.2 (CHTP1.2) compared with cigarette smoke. II. Systems toxicology assessment. , 2018, Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association.

[11]  M. Peitsch,et al.  Comparative biological impacts of an aerosol from carbon-heated tobacco and smoke from cigarettes on human respiratory epithelial cultures: A systems toxicology assessment. , 2018, Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association.

[12]  M. Peitsch,et al.  A 90-day OECD TG 413 rat inhalation study with systems toxicology endpoints demonstrates reduced exposure effects of the aerosol from the carbon heated tobacco product version 1.2 (CHTP1.2) compared with cigarette smoke. I. Inhalation exposure, clinical pathology and histopathology. , 2018, Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association.

[13]  Jennifer L. Pearson,et al.  Harm Minimization and Tobacco Control: Reframing Societal Views of Nicotine Use to Rapidly Save Lives. , 2018, Annual review of public health.

[14]  Marianna Gaça,et al.  Alternative approaches for acute inhalation toxicity testing to address global regulatory and non-regulatory data requirements: An international workshop report. , 2018, Toxicology in vitro : an international journal published in association with BIBRA.

[15]  M. Inoue,et al.  Development of a risk prediction model for lung cancer: The Japan Public Health Center‐based Prospective Study , 2018, Cancer science.

[16]  R. Weitkunat,et al.  Effects of Switching to the Tobacco Heating System 2.2 Menthol, Smoking Abstinence, or Continued Cigarette Smoking on Biomarkers of Exposure: A Randomized, Controlled, Open-Label, Multicenter Study in Sequential Confinement and Ambulatory Settings (Part 1) , 2017, Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco.

[17]  M. Peitsch,et al.  Toxicity of the main electronic cigarette components, propylene glycol, glycerin, and nicotine, in Sprague-Dawley rats in a 90-day OECD inhalation study complemented by molecular endpoints. , 2017, Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association.

[18]  Julia Hoeng,et al.  Comparative effects of a candidate modified-risk tobacco product Aerosol and cigarette smoke on human organotypic small airway cultures: a systems toxicology approach† †Electronic supplementary information (ESI) available. See DOI: 10.1039/c7tx00152e , 2017, Toxicology research.

[19]  Gary R. Mirams,et al.  Systems Toxicology: Real World Applications and Opportunities , 2017, Chemical research in toxicology.

[20]  J. LoweFrazer,et al.  Development of an Adverse Outcome Pathway for the Onset of Hypertension by Oxidative Stress-Mediated Perturbation of Endothelial Nitric Oxide Bioavailability , 2017 .

[21]  M. Peitsch,et al.  Aerosol from Tobacco Heating System 2.2 has reduced impact on mouse heart gene expression compared with cigarette smoke. , 2017, Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association.

[22]  N. Benowitz,et al.  Exposure to Nicotine and Selected Toxicants in Cigarette Smokers Who Switched to Electronic Cigarettes: A Longitudinal Within-Subjects Observational Study , 2017, Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco.

[23]  P. Pratte,et al.  Investigation of solid particles in the mainstream aerosol of the Tobacco Heating System THS2.2 and mainstream smoke of a 3R4F reference cigarette , 2017, Human & experimental toxicology.

[24]  D. Albanes,et al.  Greater Coronary Heart Disease Risk With Lower Intensity and Longer Duration Smoking Compared With Higher Intensity and Shorter Duration Smoking: Congruent Results Across Diverse Cohorts , 2016, Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco.

[25]  Julia Hoeng,et al.  3-D nasal cultures: Systems toxicological assessment of a candidate modified-risk tobacco product. , 2016, ALTEX.

[26]  M. Peitsch,et al.  Evaluation of the Tobacco Heating System 2.2. Part 1: Description of the system and the scientific assessment program. , 2016, Regulatory toxicology and pharmacology : RTP.

[27]  Julia Hoeng,et al.  Evaluation of the Tobacco Heating System 2.2. Part 4: 90-day OECD 413 rat inhalation study with systems toxicology endpoints demonstrates reduced exposure effects compared with cigarette smoke. , 2016, Regulatory toxicology and pharmacology : RTP.

[28]  P. Vanscheeuwijck,et al.  Evaluation of the Tobacco Heating System 2.2. Part 2: Chemical composition, genotoxicity, cytotoxicity, and physical properties of the aerosol. , 2016, Regulatory toxicology and pharmacology : RTP.

[29]  M. Peitsch,et al.  Evaluation of the Tobacco Heating System 2.2 (THS2.2). Part 5: microRNA expression from a 90-day rat inhalation study indicates that exposure to THS2.2 aerosol causes reduced effects on lung tissue compared with cigarette smoke. , 2016, Regulatory toxicology and pharmacology : RTP.

[30]  F. Lüdicke,et al.  Evaluation of the Tobacco Heating System 2.2. Part 8: 5-Day randomized reduced exposure clinical study in Poland. , 2016, Regulatory toxicology and pharmacology : RTP.

[31]  M. Peitsch,et al.  Quantitative proteomics analysis using 2D-PAGE to investigate the effects of cigarette smoke and aerosol of a prototypic modified risk tobacco product on the lung proteome in C57BL/6 mice. , 2016, Journal of proteomics.

[32]  G. O’Connell,et al.  Reductions in biomarkers of exposure (BoE) to harmful or potentially harmful constituents (HPHCs) following partial or complete substitution of cigarettes with electronic cigarettes in adult smokers , 2016, Toxicology mechanisms and methods.

[33]  Jie He,et al.  Epidemiology of Lung Cancer. , 2016, Surgical oncology clinics of North America.

[34]  M. Peitsch,et al.  The Apoe−/− mouse model: a suitable model to study cardiovascular and respiratory diseases in the context of cigarette smoke exposure and harm reduction , 2016, Journal of Translational Medicine.

[35]  Rémi H. J. Dulize,et al.  Effects of cigarette smoke, cessation and switching to a candidate modified risk tobacco product on the liver in Apoe−/− mice – a systems toxicology analysis , 2016, Inhalation toxicology.

[36]  M. Peitsch,et al.  Systems toxicology-based assessment of the candidate modified risk tobacco product THS2.2 for the adhesion of monocytic cells to human coronary arterial endothelial cells. , 2016, Toxicology.

[37]  Manuel C. Peitsch,et al.  Advancing Risk Assessment through the Application of Systems Toxicology , 2016, Toxicological research.

[38]  Manuel C. Peitsch,et al.  An 8-Month Systems Toxicology Inhalation/Cessation Study in Apoe−/− Mice to Investigate Cardiovascular and Respiratory Exposure Effects of a Candidate Modified Risk Tobacco Product, THS 2.2, Compared With Conventional Cigarettes , 2015, Toxicological sciences : an official journal of the Society of Toxicology.

[39]  M. Peitsch,et al.  Effects of Cigarette Smoke, Cessation, and Switching to Two Heat-Not-Burn Tobacco Products on Lung Lipid Metabolism in C57BL/6 and Apoe−/− Mice—An Integrative Systems Toxicology Analysis , 2015, Toxicological sciences : an official journal of the Society of Toxicology.

[40]  A. Schwartz,et al.  Epidemiology of Lung Cancer. , 2016, Advances in experimental medicine and biology.

[41]  M. Peitsch,et al.  Aerosol from a candidate modified risk tobacco product has reduced effects on chemotaxis and transendothelial migration compared to combustion of conventional cigarettes. , 2015, Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association.

[42]  J. Tour,et al.  Nanoparticulate carbon black in cigarette smoke induces DNA cleavage and Th17-mediated emphysema , 2015, eLife.

[43]  M. Peitsch,et al.  Toxicity of aerosols of nicotine and pyruvic acid (separate and combined) in Sprague–Dawley rats in a 28-day OECD 412 inhalation study and assessment of systems toxicology , 2015, Inhalation toxicology.

[44]  M. Peitsch,et al.  A prototypic modified risk tobacco product exhibits reduced effects on chemotaxis and transendothelial migration of monocytes compared with a reference cigarette. , 2015, Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association.

[45]  R. Weitkunat,et al.  A novel approach to assess the population health impact of introducing a Modified Risk Tobacco Product. , 2015, Regulatory toxicology and pharmacology : RTP.

[46]  Micah L. Berman,et al.  Providing a Science Base for the Evaluation of Tobacco Products. , 2015, Tobacco regulatory science.

[47]  Thomas Hartung,et al.  Integrated Testing Strategies (ITS) for safety assessment. , 2015, ALTEX.

[48]  Yong Niu,et al.  Reduced pulmonary function and increased pro-inflammatory cytokines in nanoscale carbon black-exposed workers , 2014, Particle and Fibre Toxicology.

[49]  L. Phillips,et al.  Estimating the Harms of Nicotine-Containing Products Using the MCDA Approach , 2014, European Addiction Research.

[50]  G. M. Kannan,et al.  Carbon Black Particle Exhibits Size Dependent Toxicity in Human Monocytes , 2014, International journal of inflammation.

[51]  Manuel C. Peitsch,et al.  Systems Toxicology: From Basic Research to Risk Assessment , 2014, Chemical research in toxicology.

[52]  Louis G. Iasilli.  Federal Food, Drug and Cosmetic Act , 2014 .

[53]  B. Lushniak,et al.  The Health consequences of smoking—50 years of progress : a report of the Surgeon General , 2014 .

[54]  A. Ghio,et al.  Emerging mechanistic targets in lung injury induced by combustion-generated particles. , 2013, Toxicological sciences : an official journal of the Society of Toxicology.

[55]  Rashelle B Hayes,et al.  Smoking status, physical health-related quality of life, and mortality in middle-aged and older women. , 2013, Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco.

[56]  Ann McNeill,et al.  Reducing harm from tobacco use , 2013, Journal of psychopharmacology.

[57]  S. Gebel,et al.  Lung Inflammatory Effects, Tumorigenesis, and Emphysema Development in a Long-Term Inhalation Study with Cigarette Mainstream Smoke in Mice , 2012, Toxicological sciences : an official journal of the Society of Toxicology.

[58]  P. Lee,et al.  Systematic review with meta-analysis of the epidemiological evidence relating smoking to COPD, chronic bronchitis and emphysema , 2011, BMC pulmonary medicine.

[59]  Thomas Hartung,et al.  Lessons Learned from Alternative Methods and their Validation for a New Toxicology in the 21st Century , 2010, Journal of toxicology and environmental health. Part B, Critical reviews.

[60]  Yoshihisa Okamoto,et al.  Inflammation in atherosclerosis: transition from theory to practice. , 2010, Circulation journal : official journal of the Japanese Circulation Society.

[61]  A. Rostami,et al.  Effect of smoking parameters on the particle size distribution and predicted airway deposition of mainstream cigarette smoke , 2009, Inhalation toxicology.

[62]  Office on Smoking.  How Tobacco Smoke Causes Disease: The Biology and Behavioral Basis for Smoking-Attributable Disease: A Report of the Surgeon General , 2010 .

[63]  K. Midha,et al.  Bioequivalence; Its History, Practice, and Future , 2009, The AAPS Journal.

[64]  S. Lebrun,et al.  Progression of atherosclerosis in the Apo E-/- model: 12-month exposure to cigarette mainstream smoke combined with high-cholesterol/fat diet. , 2009, Atherosclerosis.

[65]  N. Benowitz,et al.  Nicotine chemistry, metabolism, kinetics and biomarkers. , 2009, Handbook of experimental pharmacology.

[66]  장욱.  미국의 가족금연 및 담배규제법(Family Smoking Prevention and Tobacco Control Act) 제정을 통해 본 우리의 입법과제 , 2009 .

[67]  T. Mauriala,et al.  Nicotine metabolism and urinary elimination in mouse: in vitro and in vivo , 2008, Xenobiotica; the fate of foreign compounds in biological systems.

[68]  S. Tsugane,et al.  Cigarette smoking and risk of coronary heart disease incidence among middle-aged Japanese men and women: the JPHC Study Cohort I , 2006, European journal of cardiovascular prevention and rehabilitation : official journal of the European Society of Cardiology, Working Groups on Epidemiology & Prevention and Cardiac Rehabilitation and Exercise Physiology.

[69]  J. Hogg,et al.  Pathophysiology of airflow limitation in chronic obstructive pulmonary disease , 2004, The Lancet.

[70]  D. Bernstein,et al.  A Review of the Influence of Particle Size, Puff Volume, and Inhalation Pattern on the Deposition of Cigarette Smoke Particles in the Respiratory Tract , 2004, Inhalation toxicology.

[71]  Office on Smoking.  The Health Consequences of Smoking: A Report of the Surgeon General , 2004 .

[72]  M. Thun,et al.  Tobacco smoke and involuntary smoking. , 2004, IARC monographs on the evaluation of carcinogenic risks to humans.

[73]  Disease Prevention.  Clearing the Smoke : Assessing the Science Base for Tobacco Harm Reduction , 2001 .

[74]  D Hoffmann,et al.  The Less Harmful Cigarette: a Controversial Issue. a Tribute to Ernst L. Wynder , 2000 .

[75]  Risa J. Robinson,et al.  Deposition of Cigarette Smoke Particles in the Human Respiratory Tract , 2001 .

[76]  R. Wallace,et al.  Clearing the smoke: assessing the science base for tobacco harm reduction. , 2001 .

[77]  J S Lighty,et al.  Combustion Aerosols: Factors Governing Their Size and Composition and Implications to Human Health , 2000, Journal of the Air & Waste Management Association.

[78]  G. Scherer.  Smoking behaviour and compensation: a review of the literature , 1999, Psychopharmacology.

[79]  S. Greenland,et al.  A Meta-Analysis to Assess the Incidence of Adverse Effects Associated with the Transdermal Nicotine Patch , 1998, Drug safety.

[80]  J. Breslow,et al.  The emergence of mouse models of atherosclerosis and their relevance to clinical research , 1997, Journal of internal medicine.

[81]  R. A. Parent,et al.  Metabolism and Distribution of [2,3‐14C]Acrolein in Sprague‐Dawley Rats , 1996, Journal of applied toxicology : JAT.

[82]  G. L. Kedderis,et al.  Urinary metabolites of [1,2,3-13C]acrylonitrile in rats and mice detected by 13C nuclear magnetic resonance spectroscopy. , 1991, Chemical research in toxicology.

[83]  M. L. Laucks,et al.  Aerosol Technology Properties, Behavior, and Measurement of Airborne Particles , 2000 .

[84]  R. Doll,et al.  Cigarette smoking and bronchial carcinoma: dose and time relationships among regular smokers and lifelong non-smokers. , 1978, Journal of epidemiology and community health.

[85]  H. Bartsch,et al.  International Agency for Research on Cancer. , 1969, WHO chronicle.

[86]  E. Wynder,et al.  Tobacco and Tobacco Smoke , 1968, Nature.

[87]  H. W. Schultz,et al.  Federal Food, Drug, and Cosmetic Act , 1981 .