Regulatory toxicology and pharmacology : RTP
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Regul. Toxicol. Pharmacol. · Feb 2015
Randomized Controlled Trial Comparative StudyEffects of using electronic cigarettes on nicotine delivery and cardiovascular function in comparison with regular cigarettes.
The development of electronic cigarettes (e-cigs) has the potential to offer a less harmful alternative for tobacco users. This clinical study was designed to characterize e-cig users' exposure to nicotine, and to investigate the acute effects of e-cigs on the hemodynamic measurements (blood pressure and heart rate) in comparison with the effects of regular smoking. Five e-cigs and one Marlboro® cigarette were randomized for twenty-three participants under two exposure scenarios from Day 1 to Day 11: half-hour controlled administration and one hour ad lib use. ⋯ The heart rate, systolic and diastolic blood pressure were significantly elevated after use of Marlboro® cigarettes, but the elevation was less after use of most of the e-cigs. Use of e-cigs had no impact on the exhaled CO levels, whereas the Marlboro® cigarette significantly increased the exhaled CO more than 8 times above the baseline. In conclusion, e-cigs could be a less harmful alternative for tobacco users.
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Regul. Toxicol. Pharmacol. · Feb 2015
Navigating through orphan medicinal product regulations in EU and US--similarities and differences.
Rare diseases as the name suggests are the diseases which occur in a very small population due to which the development of medicinal products for these diseases is sidelined as it is anticipated that the cost of development will never be recovered from the sales. It has been estimated by National Institute of Health (NIH) that globally around 7000 rare diseases are there, many of which are of genetic origin. ⋯ It was to understand that how these legal instruments have stimulated the growth of the drug products for rare diseases and what other things can be done in order to achieve a better impact. This article also provides an overview of the various incentives offered as well as challenges and hurdles faced by each of these regulatory agencies while implementing these regulations.
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Regul. Toxicol. Pharmacol. · Dec 2014
Comparative StudyComparison of select analytes in aerosol from e-cigarettes with smoke from conventional cigarettes and with ambient air.
Leading commercial electronic cigarettes were tested to determine bulk composition. The e-cigarettes and conventional cigarettes were evaluated using machine-puffing to compare nicotine delivery and relative yields of chemical constituents. The e-liquids tested were found to contain humectants, glycerin and/or propylene glycol, (⩾75% content); water (<20%); nicotine (approximately 2%); and flavor (<10%). ⋯ Analysis of the smoke from conventional cigarettes showed that the mainstream cigarette smoke delivered approximately 1500times more harmful and potentially harmful constituents (HPHCs) tested when compared to e-cigarette aerosol or to puffing room air. The deliveries of HPHCs tested for these e-cigarette products were similar to the study air blanks rather than to deliveries from conventional cigarettes; no significant contribution of cigarette smoke HPHCs from any of the compound classes tested was found for the e-cigarettes. Thus, the results of this study support previous researchers' discussion of e-cigarette products' potential for reduced exposure compared to cigarette smoke.
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Regul. Toxicol. Pharmacol. · Dec 2014
Toxicological assessment of kretek cigarettes: Part 2: kretek and American-blended cigarettes, smoke chemistry and in vitro toxicity.
Two commercial kretek cigarettes typical for the Indonesian market and a reference kretek cigarette were compared to the American-blended reference cigarette 2R4F by smoke chemistry characterization and in vitro cytotoxicity and mutagenicity assessments. Despite the widely diverse designs and deliveries of the selected kretek cigarettes, their smoke composition and in vitro toxicity data present a consistent pattern when data were normalized to total particulate matter (TPM) deliveries. This confirms the applicability of the studies' conclusions to a wide range of kretek cigarette products. ⋯ Yields of light molecular weight pyrolytic compounds, notably aldehydes and hydrocarbons, were reduced, while yields of polycyclic aromatic hydrocarbons were unchanged and phenol yield was increased. The normalized in vitro toxicity was lowered accordingly, reflecting the yield reductions in gas-phase cytotoxic compounds and some particulate-phase mutagenic compounds. These results do not support a higher toxicity of the smoke of kretek cigarettes compared to American-blended cigarettes.
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Regul. Toxicol. Pharmacol. · Dec 2014
Toxicological assessment of kretek cigarettes. Part 7: the impact of ingredients added to kretek cigarettes on inhalation toxicity.
The biological activity of mainstream smoke from experimental kretek cigarettes with and without three mixes of ingredients was assessed in a 90-day rat inhalation study and in a 4-day in vivo micronucleus assay. 350 ingredients, commonly used in various combinations and in a limited number in a given brand in the manufacture of marketed kretek cigarettes, were applied at a low and a high target level to test cigarettes with a typical Indonesian blend of tobaccos and cloves. In the 90-day inhalation study, effects commonly seen in rat inhalation studies with mainstream smoke were observed. ⋯ In the 4-day micronucleus assay exposure of male rats to mainstream smoke from the test cigarettes containing any of the three mixes did not increase the proportions of micronucleated cells in peripheral blood and bone marrow over the proportion of micronucleated cells in the control group. Based on the results of these studies, it can be concluded that the addition of ingredients commonly used in the manufacture of kretek cigarettes did not change the overall in vivo toxicity profile of the mainstream smoke.