Accurate characterization of charge variants in biologics is crucial to uphold stringent quality standards ensuring the safety and efficacy of biotherapeutic products and regulatory requirements for the Biologic Licensing Application (BLA) process enabling marketing application. These variants, arising from post-translational modifications (PTMs) during upstream processing and enzymatic/nonenzymatic reactions in downstream processing and storage, can significantly impact therapeutic potency, efficacy, and immunogenicity. Conventional methods for characterizing charge variants typically involve labor-intensive fraction enrichment, consuming time and resources.
View Article and Find Full Text PDFObjective: Proposition 56, a $2 tobacco tax enacted in California in 2016, led to increased funding to Local Lead Agencies which work to reduce tobacco use. We examined whether Proposition 56 was associated with increases in the population covered by local policies addressing four areas: 1) tobacco retail sales (TRS), 2) flavored tobacco products sales (FTP), 3) outdoor secondhand smoke (SHS) restrictions, and 4) smoking restrictions in multi-unit housing (MUH).
Methods: 2007-2023 data from the Policy Evaluation Tracking System in California were analyzed.
JAMA Netw Open
April 2025
Importance: There are still significant population-level health consequences of cigarette smoking in US states.
Objective: To estimate whether differential sociodemographic trends in smoking prevalence since 1992 will close the prevalence gap between states by 2035.
Design, Setting, And Participants: This cross-sectional study included data from 18 repeated, state-representative US Tobacco Use Supplement to the Current Population Surveys (TUS-CPS) from 1992 to 2022.
Importance: An important public health goal is to increase tobacco cessation, but there is limited research on associations of vaping with tobacco cessation.
Objective: To estimate the association of vaping with long-term tobacco cessation among US cigarette smokers who used electronic nicotine delivery systems (ENDS; ie, e-cigarettes) in 2017.
Design, Setting, And Participants: This cohort study used a nationally representative sample of US cigarette smokers from the Population Assessment of Tobacco and Health cohort at wave 4 (2017) with follow-up at wave 6 (2021).
Objective: To investigate the association of state-level cigarette price and tobacco control expenditure with the large 2000-2019 decline in cigarette smoking among US 18-24 year-olds.
Methods: Smoking behaviour was assessed in the 24 most populous US states using the 1992-2019 Tobacco Use Supplements to the Current Population Survey; association with price and expenditure was tested using adjusted logistic regression. States were ranked by inflation-adjusted average price and tobacco control expenditure and grouped into tertiles.
Exp Clin Psychopharmacol
December 2024
Intranasal oxytocin (INOT) has received attention as a treatment for substance use disorders including tobacco dependence. However, it is unclear whether INOT-related effects differ by sex and social functioning traits. This study examined the influence of sex and two trait social functioning measures (hostility and rejection sensitivity) on INOT effects on abstinence-related subjective measures and smoking lapse.
View Article and Find Full Text PDFInfection from the dengue virus can manifest with a variety of clinical presentations. Cardiac involvement from dengue fever is a rarely reported phenomenon with significant morbidity and mortality. We illustrate the case of a 47-year-old male admitted to the hospital with fevers.
View Article and Find Full Text PDFBackground: E-cigarette product characteristics are known to influence appeal among young adults. Understanding which characteristics appeal to individuals with (vs. without) a history of combusted tobacco use is essential for developing effective tobacco control policies.
View Article and Find Full Text PDFBackground: Young adults 18-24 years old have the highest prevalence of cigarillo use, exposing young adults to comparable or higher nicotine levels and many of the same toxicants as combustible cigarettes. Identifying individual and product characteristics that increase the potential for persistent use is warranted. We sought to examine the interacting effects of depression symptoms and sweet flavoring on the rewarding and reinforcing value of cigarillo use.
View Article and Find Full Text PDFObjective: To compare trends in cigarette smoking and nicotine vaping among US population aged 17-18 years and 18-24 years.
Methods: Regression analyses identified trends in ever and current use of cigarettes and e-cigarettes, using three US representative surveys from 1992 to 2022.
Results: From 1997 to 2020, cigarette smoking prevalence among those aged 18-24 years decreased from 29.
Objective: Plain packaging and graphic warning labels are two regulatory strategies that may impact cigarette risk beliefs and reduce consumption, but data are needed to better understand how smokers respond to such regulations.
Methods: Adult, daily, Marlboro non-menthol smokers (Red [n = 141] or Gold [n = 43]) completed a mixed factorial randomized trial. Participants smoked their usual cigarettes during baseline (5-days) and were randomized to receive cigarette packs with a warning label manipulation (graphic vs.
Int J Environ Res Public Health
July 2023
Research suggests consumers may misunderstand modified risk tobacco product (MRTP) claims. We examined the effects of nicotine content across four tobacco products with and without MRTP claims among a racially and ethnically diverse sample of adults who do and do not smoke. Adults ( = 1484) aged 21-65 completed an online experiment using a 2 × 2 × 4 mixed factorial design to examine the effects of tobacco product (Classic White Snus, IQOS, JUUL e-cigarette, and VLN cigarette) and nicotine content (high vs.
View Article and Find Full Text PDFIntroduction: Research that explores the clinical relevance of subclinical depressive symptoms and smoking is primarily focused on smoking cessation. We examine whether depression symptoms vary across an array of biological (carbon monoxide boost), behavioral (FagerströmTest of Nicotine Dependence, cigarettes per day, smoking topography), and psychological smoking-related outcomes (Questionnaire on Smoking Urges, Withdrawal Symptoms Checklist) in non-treatment-seeking smokers.
Methods: Baseline data were pooled from three research trials with identical procedures designed to assess individual smoking behavior using smokers preferred cigarette brands.
Introduction: This study examined trajectories of tobacco dependence (TD) in relationship to changes in tobacco product use, and explored the effects of product-specific adding, switching, or discontinued use on dependence over time.
Aims And Methods: Data were analyzed from the first three waves from the Population Assessment of Tobacco and Health (PATH) Study, a nationally representative, longitudinal study of adults and youth in the United States. Data included 9556 wave 1 (2013-2014) adult current established tobacco users aged 18 or older who completed all three interviews and had established use at ≥2 assessments.
Introduction: Understanding the reasons young adults use e-cigarettes (ie, vape)-and whether these motivations vary across groups-is essential for informing tobacco regulatory efforts.
Aims And Methods: An online panel of young adults who vape (n = 230; age = 18-30 years) completed a maximum difference discrete choice task for 15 reasons for vaping. Over 9 choice sets, participants were presented a subset of 5 reasons and selected the most and least important.
Background: IQOS is a heated tobacco product marketed as an alternative to combustible cigarette smoking. Little is known about cigarette smokers' IQOS health risk perceptions and if these risk perceptions impact IQOS use and cigarette smoking behaviour.
Methods: Adult, daily, non-treatment-seeking cigarette smokers (n=27), naïve to IQOS, were recruited from Philadelphia, Pennsylvania, USA.
Background: It is unknown whether IQOS-associated decreases in cigarette craving, nicotine withdrawal, greater subjective reward, and relative reinforcing value predict subsequent switching from cigarettes to IQOS products.
Methods: Nontreatment-seeking adult daily smokers (n = 33; 18-65 years old) completed a within-subject pilot study consisting of a baseline ad-lib smoking period (days 1-5), two laboratory visits (days 6-7), and a two-week period where participants switch from using cigarettes to using IQOS (days 8-21). Mixed-effect modelling estimated the percentage of baseline cigarette consumption replaced by daily IQOS HeatSticks used.
Introduction: This study examined trajectories of tobacco dependence (TD) in relation to changes in tobacco product use and explored the effects of product-specific adding, switching, or discontinued use on dependence over time.
Aims And Methods: Data were analyzed from the first three waves of the Population Assessment of Tobacco and Health (PATH) Study, a nationally representative, longitudinal study of adults and youth in the United States. Data included 9556 Wave 1 (2013/2014) adult current established tobacco users who completed all three interviews and had established use at ≥2 assessments.
Importance: The inclusion of graphic warning labels (GWLs) on cigarette packs is recommended for tobacco control but has not yet been implemented in the US. It is unknown whether and to what extent the inclusion of GWLs on cigarette packs affects smokers' willingness to display the packs in public.
Objective: To determine whether the inclusion of GWLs on cigarette packs affects pack-hiding behavior among smokers in social settings.
Importance: Although e-cigarettes are not approved as a cessation device, many who smoke believe that e-cigarettes will help them quit cigarette smoking successfully.
Objective: To assess whether people who recently quit smoking and who had switched to e-cigarettes or another tobacco product were less likely to relapse to cigarette smoking compared with those who remained tobacco free.
Design, Setting, And Participants: This cohort study analyzed a nationally representative sample of US households that participated in 4 waves of the Population Assessment of Tobacco and Health Study (conducted 2013 through 2017), combining 2 independent cohorts each with 3 annual surveys.
Importance: The US Food and Drug Administration's implementation of graphic warning labels (GWLs) on cigarette packs is under challenge in US courts.
Objective: To determine whether GWLs can affect US smokers' perceptions about their cigarettes or health consequences and changes in smoking behavior.
Design, Setting, And Participants: This study was a randomized clinical trial of the effect of a 3-month, real-world experience of cigarettes with GWL packaging.
Background: Xylazine is an α-2 adrenoreceptor agonist used as a sedative/analgesic in veterinary medicine. Xylazine is known to be present within the street supply of opiates in urban Philadelphia. Medical staff at our hospital asked if we could test for xylazine in fentanyl screen-positive urine samples.
View Article and Find Full Text PDFInt J Environ Res Public Health
June 2021
Vaping products containing cannabidiol (CBD), a cannabis-derived compound used in wellness products and available in all 50 US states, were recently implicated in outbreaks of poisonings. Little is known about the commercial availability of CBD products in vape shops (i.e.
View Article and Find Full Text PDFObjectives: To identify predictors of becoming a daily cigarette smoker over the course of 4 years.
Methods: We identified 12- to 24-year-olds at wave 1 of the US Population Assessment of Tobacco and Health Study and determined ever use, age at first use, and daily use through wave 4 for 12 tobacco products.
Results: Sixty-two percent of 12- to 24-year-olds (95% confidence interval [CI]: 60.