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https://www.readbyqxmd.com/read/28817320/tobacco-industry-research-on-nicotine-replacement-therapy-if-anyone-is-going-to-take-away-our-business-it-should-be-us
#1
Dorie Apollonio, Stanton A Glantz
Nicotine replacement therapy (NRT) is recommended for tobacco cessation on the basis of pharmaceutical industry research showing its effectiveness when combined with counseling. The tobacco industry opposed NRT when it first appeared in the 1980s but by 2016 was marketing its own NRT products. We used internal tobacco industry documents dated 1960 through 2010 to identify the industry's perceptions of NRT. As early as the 1950s, tobacco companies developed nonsmoked nicotine replacements for cigarettes, but they stopped out of concern that marketing such products would trigger Food and Drug Administration regulation of cigarettes...
August 17, 2017: American Journal of Public Health
https://www.readbyqxmd.com/read/28816053/in-vitro-exposure-systems-and-dosimetry-assessment-tools-for-inhaled-tobacco-products-workshop-proceedings-conclusions-and-paths-forward-for-in-vitro-model-use
#2
Holger Behrsing, Erin Hill, Hans Raabe, Raymond Tice, Suzanne Fitzpatrick, Robert Devlin, Kent Pinkerton, Günter Oberdörster, Chris Wright, Roman Wieczorek, Michaela Aufderheide, Sandro Steiner, Tobias Krebs, Bahman Asgharian, Richard Corley, Michael Oldham, Jason Adamson, Xiang Li, Irfan Rahman, Sonia Grego, Pei-Hsuan Chu, Shaun McCullough, Rodger Curren
In 2009, the passing of the Family Smoking Prevention and Tobacco Control Act facilitated the establishment of the FDA Center for Tobacco Products (CTP), and gave it regulatory authority over the marketing, manufacture and distribution of tobacco products, including those termed 'modified risk'. On 4-6 April 2016, the Institute for In Vitro Sciences, Inc. (IIVS) convened a workshop conference entitled, In Vitro Exposure Systems and Dosimetry Assessment Tools for Inhaled Tobacco Products, to bring together stakeholders representing regulatory agencies, academia and industry to address the research priorities articulated by the FDA CTP...
July 2017: Alternatives to Laboratory Animals: ATLA
https://www.readbyqxmd.com/read/28815982/bridge-the-gap-the-need-for-harmonized-regulatory-and-ethical-standards-for-postmarketing-observational-studies
#3
REVIEW
Hisashi Urushihara, Louise Parmenter, Shimon Tashiro, Kenji Matsui, Nancy Dreyer
Drug safety issues do not respect national borders. Hence, addressing a safety question may necessitate globally coordinated efforts between regulatory authorities and market authorization holders (MAHs) to draw reliable conclusions. Regulatory authorities have shared responsibility with MAHs sponsoring postmarketing nonintervention studies in determining study goals and design. Their shared accountabilities include what will be investigated and how the data will be retrieved to ensure appropriate study quality required for regulatory decision making...
August 16, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28815894/challenges-of-developing-and-conducting-clinical-trials-in-rare-disorders
#4
REVIEW
Lucas Kempf, Jonathan C Goldsmith, Robert Temple
Rare disease drug development is a rapidly expanding field. Clinical researchers in rare diseases face many challenges when conducting trials in small populations. Disease natural history is often poorly understood and the ability to detect clinically meaningful outcomes requires understanding of their rate of occurrence and variability, both of which contribute to difficulties in powering a study. Standard trial designs are not optimized to obtain adequate safety and efficacy data from small numbers of patients, so alternative designs (enrichment, crossover, adaptive, N-of 1) need to be considered...
August 16, 2017: American Journal of Medical Genetics. Part A
https://www.readbyqxmd.com/read/28815480/evaluation-of-electronic-healthcare-databases-for-post-marketing-drug-safety-surveillance-and-pharmacoepidemiology-in-china
#5
Yu Yang, Xiaofeng Zhou, Shuangqing Gao, Hongbo Lin, Yanming Xie, Yuji Feng, Kui Huang, Siyan Zhan
INTRODUCTION: Electronic healthcare databases (EHDs) are used increasingly for post-marketing drug safety surveillance and pharmacoepidemiology in Europe and North America. However, few studies have examined the potential of these data sources in China. METHODS: Three major types of EHDs in China (i.e., a regional community-based database, a national claims database, and an electronic medical records [EMR] database) were selected for evaluation. Forty core variables were derived based on the US Mini-Sentinel (MS) Common Data Model (CDM) as well as the data features in China that would be desirable to support drug safety surveillance...
August 16, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28813502/addressing-the-challenge-of-high-priced-prescription-drugs-in-the-era-of-precision-medicine-a-systematic-review-of-drug-life-cycles-therapeutic-drug-markets-and-regulatory-frameworks
#6
Toon van der Gronde, Carin A Uyl-de Groot, Toine Pieters
CONTEXT: Recent public outcry has highlighted the rising cost of prescription drugs worldwide, which in several disease areas outpaces other health care expenditures and results in a suboptimal global availability of essential medicines. METHOD: A systematic review of Pubmed, the Financial Times, the New York Times, the Wall Street Journal and the Guardian was performed to identify articles related to the pricing of medicines. FINDINGS: Changes in drug life cycles have dramatically affected patent medicine markets, which have long been considered a self-evident and self-sustainable source of income for highly profitable drug companies...
2017: PloS One
https://www.readbyqxmd.com/read/28813010/characterization-of-breakfast-cereals-available-in-the-mexican-market-sodium-and-sugar-content
#7
Claudia Nieto, Sofia Rincon-Gallardo Patiño, Lizbeth Tolentino-Mayo, Angela Carriedo, Simón Barquera
Preschool Mexican children consume 7% of their total energy intake from processed breakfast cereals. This study characterized the nutritional quality and labelling (claims and Guideline Daily Amount (GDA)) of the packaged breakfast cereals available in the Mexican market. Photographs of all breakfast cereals available in the 9 main food retail chains in the country were taken. The nutrition quality of cereals was assessed using the United Kingdom Nutrient Profiling Model (UKNPM). Claims were classified using the International Network for Food and Obesity/non-communicable Diseases Research, Monitoring and Action Support (INFORMAS) taxonomy and the GDA was defined according to the Mexican regulation, NOM-051...
August 16, 2017: Nutrients
https://www.readbyqxmd.com/read/28812885/ecological-risk-assessment-of-nano-enabled-pesticides-a-perspective-on-problem-formulation
#8
Glen W Walker, Rai S Kookana, Natalie E Smith, Melanie Kah, Casey Doolette, Philip Reeves, Wess Lovell, Darren J Anderson, Terence W Turney, Divina A Navarro
Plant protection products containing nanomaterials that alter the functionality or risk profile of active ingredients (nano-enabled pesticides) promise many benefits over conventional pesticide products. These benefits may include improved formulation characteristics, easier application, better targeting of pest species, increased efficacy, lower application rates, and enhanced environmental safety. After many years of research and development, nano-enabled pesticides are starting to make their way onto the market...
August 16, 2017: Journal of Agricultural and Food Chemistry
https://www.readbyqxmd.com/read/28811221/is-the-hype-around-the-reproductive-health-claims-of-maca-lepidium-meyenii-walp-justified
#9
REVIEW
Shruti Beharry, Michael Heinrich
ETHNOPHARMACOLOGICAL RELEVANCE: Maca - Lepidium meyenii Walp has been cultivated and used by Andean people for over 1,300 to 2000 years in Peru as food and medicine. Starting in the late 1990's it has developed into an important herbal medicine in China and is now cultivated there widely, too. AIM OF STUDY: This study aims to provide an insight into the emergence of maca on the global market as an alternative remedy to treat reproductive health related problems in both men and women and to critically assess these health claims...
August 12, 2017: Journal of Ethnopharmacology
https://www.readbyqxmd.com/read/28810157/propagating-the-haze-community-and-professional-perceptions-of-cannabis-cultivation-and-the-impacts-of-prohibition
#10
Helen Beckett Wilson, Stuart Taylor, Giles Barrett, Janet Jamieson, Lauren Grindrod
BACKGROUND: Recent decades have seen substantial changes in the UK cannabis landscape, including increased domestic production, the ascendancy of stronger strains (namely 'skunk') and the drug's reclassification under the 1971 Misuse of Drugs Act. Resultantly, cannabis retains significance in the consciousness, priorities and policy agendas of communities, drug services and criminal justice agencies. METHODS: This paper presents an empirical study, which examined both perceptions and impacts of cannabis cultivation and its control within a North-West English borough...
August 12, 2017: International Journal on Drug Policy
https://www.readbyqxmd.com/read/28810061/single-dose-pharmacokinetics-of-co-crystal-of-tramadol-celecoxib-results-of-a-4-way-randomized-open-label-phase-i-clinical-trial-in-healthy-subjects
#11
Sebastián Videla, Mounia Lahjou, Anna Vaqué, Mariano Sust, Mercedes Encabo, Lluis Soler, Artur Sans, Eric Sicard, Neus Gascón, Gregorio Encina, Carlos Plata-Salamán
AIM: Co-Crystal of Tramadol-Celecoxib (CTC) is a novel co-crystal molecule containing two active pharmaceutical ingredients (APIs) under development by Esteve (E-58425) and Mundipharma Research (MR308). This Phase I study compared single-dose pharmacokinetics (PK) of CTC with those of the individual reference products (immediate-release [IR] tramadol and celecoxib) alone and in open combination. METHODS: Healthy adults aged 18-55 years were orally administered four treatments under fasted conditions (separated by 7-day wash-out period): 200 mg IR CTC (equivalent to 88 mg tramadol and 112 mg celecoxib; Treatment-1); 100 mg IR tramadol (Treatment-2); 100 mg celecoxib (Treatment-3); and 100 mg IR tramadol and 100 mg celecoxib (Treatment-4)...
August 15, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28809786/octopus-a-design-methodology-for-motion-capture-wearables
#12
Javier Marin, Teresa Blanco, Jose J Marin
Human motion capture (MoCap) is widely recognised for its usefulness and application in different fields, such as health, sports, and leisure; therefore, its inclusion in current wearables (MoCap-wearables) is increasing, and it may be very useful in a context of intelligent objects interconnected with each other and to the cloud in the Internet of Things (IoT). However, capturing human movement adequately requires addressing difficult-to-satisfy requirements, which means that the applications that are possible with this technology are held back by a series of accessibility barriers, some technological and some regarding usability...
August 15, 2017: Sensors
https://www.readbyqxmd.com/read/28809590/brand-trust-and-image-effects-on-customer-satisfaction
#13
Sayed Hamid Khodadad Hosseini, Leila Behboudi
Purpose The purpose of this paper is to investigate brand trust and brand image effects on healthcare service users. Nowadays, managers and health activists are showing increased tendency to marketing and branding to attract and satisfy customers. Design/methodology/approach The current study's design is based on a conceptual model examining brand trust and brand image effects on customer satisfaction. Data obtained from 240 questionnaires (310 respondents) were analyzed using path analysis. Findings Results revealed that the most effective items bearing the highest influence on customer satisfaction and on benefiting from healthcare services include brand image, staff sincerity to its patients, interactions with physicians and rapport...
August 14, 2017: International Journal of Health Care Quality Assurance
https://www.readbyqxmd.com/read/28808506/the-knowledge-concerns-and-healthcare-practices-among-physicians-regarding-electronic-cigarettes
#14
Venkatkiran Kanchustambham, Swetha Saladi, Jonathan Rodrigues, Hermina Fernandes, Setu Patolia, Sadhashiv Santosh
Background: Electronic cigarettes (e-cigarettes) are battery-powered devices that deliver aerosolized nicotine. With easy access and over-the-counter availability, many patients consider using electronic cigarettes for smoking cessation. Few studies have looked at long-term safety/efficacy and physician knowledge/attitudes toward e-cigarettes. Physicians have insufficient guidelines for advising their patients about e-cigarettes. Objective: 1) To identify knowledge and attitude of health care practitioners toward electronic cigarettes...
July 2017: Journal of Community Hospital Internal Medicine Perspectives
https://www.readbyqxmd.com/read/28807603/stem-cell-industry-update-2012-to-2016-reveals-accelerated-investment-but-market-capitalization-and-earnings-lag
#15
Mitchell Ng, Simon Song, Nicolas S Piuzzi, Kenneth Ng, Chukwuweike Gwam, Michael A Mont, George F Muschler
Treatments based on stem cells have long been heralded for their potential to drive the future of regenerative medicine and have inspired increasing medical and business interest. The stem cell therapy market has been expanding since 2012, but earnings and profitability still lag the broader health care sector (compounded annual growth rate in annual financing of 31.5% versus 13.4%, respectively). On the basis of historical financial data, approximately $23 billion has been invested in stem cell companies since 1994, with more than 80% of this raised from 2011 through 2016...
August 11, 2017: Cytotherapy
https://www.readbyqxmd.com/read/28805961/reducing-branded-prescription-drug-prices-a-review-of-policy-options
#16
G Caleb Alexander, Jeromie Ballreich, Mariana P Socal, Taruja Karmarkar, Antonio Trujillo, Jeremy Greene, Joshua Sharfstein, Gerard Anderson
The high prices of specialty pharmaceuticals are causing some public programs to ration care and many private insurers, including Medicare drug plans, to place specialty drugs on high cost sharing tiers. As a result, access to these drugs is severely restricted, and only a small portion of the population with the disease is receiving treatment. This concern has generated a wide range of proposed solutions. We conducted a literature review and identified fifty-two solutions in the peer reviewed literature that we classified into five broad categories: revising the patent system; encouraging research to increase development of new drugs; altering pharmaceutical regulation; decreasing market demand; and developing innovative pricing strategies...
August 14, 2017: Pharmacotherapy
https://www.readbyqxmd.com/read/28803883/the-provision-of-emergency-contraception-in-kinshasa-s-private-sector-pharmacies-experiences-of-mystery-clients
#17
Julie H Hernandez, Mbadu Muanda Fidèle, Mélissa Garcia, Annie Glover
OBJECTIVES: Recent programmatic and research efforts on addressing gaps in health systems of low-income countries increasingly see task shifting, i.e. the provision of healthcare by non-medically trained personnel, as a possible solution to increase the availability of specific services and commodities. In Kinshasa, private-sector pharmacies are the primary and preferred provider of family planning (FP) methods, and thus constitute a potential resource for expanding access to specific contraceptives...
August 10, 2017: Contraception
https://www.readbyqxmd.com/read/28803699/crowdsourcing-samples-in-cognitive-science
#18
REVIEW
Neil Stewart, Jesse Chandler, Gabriele Paolacci
Crowdsourcing data collection from research participants recruited from online labor markets is now common in cognitive science. We review who is in the crowd and who can be reached by the average laboratory. We discuss reproducibility and review some recent methodological innovations for online experiments. We consider the design of research studies and arising ethical issues. We review how to code experiments for the web, what is known about video and audio presentation, and the measurement of reaction times...
August 10, 2017: Trends in Cognitive Sciences
https://www.readbyqxmd.com/read/28802433/a-survey-of-the-prevalence-of-fatigue-its-precursors-and-individual-coping-mechanisms-among-u-s-manufacturing-workers
#19
Lin Lu, Fadel M Megahed, Richard F Sesek, Lora A Cavuoto
Advanced manufacturing has resulted in significant changes on the shop-floor, influencing work demands and the working environment. The corresponding safety-related effects, including fatigue, have not been captured on an industry-wide scale. This paper presents results of a survey of U.S. manufacturing workers for the: prevalence of fatigue, its root causes and significant factors, and adopted individual fatigue coping methods. The responses from 451 manufacturing employees were analyzed using descriptive data analysis, bivariate analysis and Market Basket Analysis...
November 2017: Applied Ergonomics
https://www.readbyqxmd.com/read/28801207/crediblemeds-org-what-does-it-offer
#20
REVIEW
Raymond L Woosley, Kristin Black, C William Heise, Klaus Romero
Since the 1990s, when numerous non-cardiac drugs were first recognized to have the potential to prolong the QT interval and cause torsades de pointes (TdP), clinicians, drug regulators, drug developers, and clinical investigators have become aware of the complexities of assessing evidence and determining TdP causality for the many drugs being marketed or under development. To facilitate better understanding, the Arizona Center for Education and Research on Therapeutics, known as AZCERT, has developed the CredibleMeds...
August 1, 2017: Trends in Cardiovascular Medicine
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