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Carabin, Ioana G., George A. Burdock, and Chris Chatzidakis. "Safety Assessment of Panax Ginseng." International Journal of Toxicology 19, no. 4 (July 2000): 293–301. http://dx.doi.org/10.1080/10915810050202105.
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Since the 1994 Dietary Supplement Health and Education Act, the consumption of botanical supplements has increased to the point where ginseng is the third best selling herbal supplement in the United States and it is now also being used as a flavoring agent in foods. The predominant pharmacologically active constituents of Panax are ginsenosides, at least 25 of which have been identified and are present in variable amounts and ratios to one another, depending on the particular species, variety, and conditions of growth. The toxicological profile of ginseng indicates it to be of rather low acute oral toxicity (LD50 > 5000 mg/kg for rats and mice, approximating 200 mg ginsenoside/kg.) No toxicological effects were identified in mini pigs at a dose of 2000 mg/kg (80 mg ginsenoside/kg). As concluded from a 90-day dog study and in reproduction studies in rats and mice, 15 mg/kg (∼ 0.6 mg ginsenoside/kg) was without effect. No effect was seen in rats administered 4000 mg/kg (160 mg ginsenoside/kg) for 20 days. There was no mutagenic activity observed in Salmonella typhimurium TM677 system with the use of ginseng in the presence or absence of metabolic activation. The no-observed-adverse-effectlevel (NOAEL) in rodents is likely within the range of 50 to 100 mg ginsenoside/kg. There are no confirmed reports of adverse reactions in humans attributed to ginseng alone. Importantly, no consistent symptomology or findings have been attributed to, or identified as being associated with, ginseng consumption. Ginseng extracts standardized at a concentration of 4 mg ginsenosides/100 mg capsule and given at a dose of up to 114 θ g ginsenoside/kg have not resulted in untoward effects when administered to humans for periods of up to 12 weeks.
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Senecal, Joseph A., and Patricia A. Beaulieu. "KG: New data and analysis." Process Safety Progress 17, no. 1 (1998): 9–15. http://dx.doi.org/10.1002/prs.680170104.
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Diddi Sneha Latha and Arulmozhi S. "Safety Pharmacological studies of Kalyanaka ghrita." International Journal of Research in Pharmaceutical Sciences 12, no. 3 (August 3, 2021): 2155–63. http://dx.doi.org/10.26452/ijrps.v12i3.4827.
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Safety pharmacology is a study of unfavorable, pharmacodynamic effects of a drug on physiological functions with therapeutic range by using International Conference on Harmonization (ICH) S7A guidelines. The cardiovascular, central nervous, and respiratory systems are most affected by pharmacological side effects, resulting withdrawal of multiple medications from the market. Kalyanaka ghrita (KG) is an Ayurvedic formulation with ghee as a major basic component, though a promising candidate in treatment of AD, KG has not been documented for its safety profile, which prompted the study. In this study we evaluated safety pharmacology of KG oral (4, 2, 1g/kg), and nasal (100, 50, 25 µl/rat), in Wistar rats for 28 days subjected to CNS, CVS and the respiratory safety profile was evaluated on day 0, 14 and 28. At the end of the study the nasal turbinate was evaluated histopathologically. In the present study KG did not cause any significant change in CNS profile. However KG treatment had increased the grooming and rearing behaviors, which were not significant compared to vehicle control and did not cause change in CVS and respiratory profile upon treatment with KG for 28 days. The epithelium of nasal turbinate of animals was found intact after 28 days of nasal administration. After sustained dosing, the KG oral and intranasal treated groups showed no harmful events, which illustrates the CNS, CVS and respiratory safety profile of Kalyanaka ghrita.
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Zhou, Yuting, Claire Kruger, GS Ravi, DP Santhosh Kumar, SK Vijayasarathi, Mayuri Lavingia, Xiaoyan Chen, and Pamela Ambriz. "Safety evaluation of galacto-oligosaccharides." Toxicology Research and Application 1 (January 1, 2017): 239784731771586. http://dx.doi.org/10.1177/2397847317715864.
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Galacto-oligosaccharides (GOS) have been added to infant formulas and conventional foods as prebiotics all over the world. The present study was conducted to assess the subchronic toxicity of a GOS syrup (VITAGOS™) when administered orally by gavage daily at 0, 1020, 2041, and 4082 mg GOS syrup/kg/day to male and female Sprague-Dawley rats to deliver doses of 0, 500, 1000, and 2000 mg GOS/kg/day for 90 days. Throughout the entire treatment period, no abnormal clinical signs or mortalities were observed. Similarly, no test article-related toxicologically adverse findings were seen in body weight, feed consumption, ophthalmological findings, hematology, coagulation, clinical chemistry, urinalysis, organ weights, and gross pathology or histopathology. Significant increases in the cecum weight of males and females treated with 2000 mg GOS/kg/day were associated with mucosal hypertrophy/hyperplasia; no changes in the cecum were noted at lower doses. The organ weight and histopathological changes noted in the cecum are consistent with findings in rats administered other poorly digestible and fermentable substances; thus, this is considered to be an adaptive rather than toxic response. The No-Observed-Adverse-Effect-Levels for VITAGOS™ is 4082 mg GOS syrup/kg body weight/day or 2000 mg GOS/kg body weight/day.
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Momtaz, Parisa, Vivian Park, Katherine S. Panageas, Michael A. Postow, Margaret Callahan, Jedd D. Wolchok, and Paul B. Chapman. "Safety of Infusing Ipilimumab Over 30 Minutes." Journal of Clinical Oncology 33, no. 30 (October 20, 2015): 3454–58. http://dx.doi.org/10.1200/jco.2015.61.0030.
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Purpose The approved dose of ipilimumab is 3 mg/kg infused over 90 minutes; however, in clinical trials, 10 mg/kg has also been infused over 90 minutes. At this higher dose, patients receive 3 mg/kg within the first 27 minutes of treatment. We sought to determine whether the standard dose of 3 mg/kg could be safely infused over 30 minutes. Methods We reviewed retrospectively the incidence of infusion-related reactions (IRRs) to ipilimumab at our institution in patients receiving doses of either 3 or 10 mg/kg infused over 90 minutes. Our findings led to a change in institutional guidelines for ipilimumab infusion time from 90 minutes to 30 minutes. We reviewed the first 14 months of our prospective experience using a 30-minute infusion of ipilimumab. Results Between April 1, 2008, and June 30, 2013, 595 patients received 2,507 doses of ipilimumab infused at either 3 mg/kg (n = 457) or 10 mg/kg (n = 138) over 90 minutes. Although the 10 mg/kg group had a higher incidence of IRRs (4.3%) than the 3 mg/kg group (2.2%), this difference was not statistically significant (P = .22). In 120 patients treated prospectively with ipilimumab 3 mg/kg infused over 30 minutes, seven patients (5.8%) had an IRR (P = .06 compared with 90-minute infusions). All IRRs occurred at dose 2; six were grade 2, and one was grade 3. All seven patients received subsequent doses of ipilimumab safely, the majority with premedication. Conclusion Ipilimumab at 3 mg/kg can be infused safely over 30 minutes with an acceptably low incidence of IRRs. After an IRR, patients can safely receive additional doses of ipilimumab with premedication.
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Sullivan, Dexter W., Shayne C. Gad, Bryan Laulicht, Sasha Bakhru, and Solomon Steiner. "Nonclinical Safety Assessment of PER977." International Journal of Toxicology 34, no. 4 (June 15, 2015): 308–17. http://dx.doi.org/10.1177/1091581815590667.
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A new molecular entity, PER977 (di-arginine piperazine), is in clinical development as an anticoagulant reversal agent for new oral anticoagulants and heparins. The good laboratory practices (GLP)-compliant studies were conducted to evaluate the toxicity of PER977 and its primary metabolite, 1,4-bis(3-aminopropyl)piperazine (BAP). PER977 and BAP were negative for systemic toxicity in dogs and rats. PER977 was rapidly eliminated from the blood with little to no accumulation. PER977 was negative for genotoxicity and did not alter neurological, respiratory, or cardiovascular function. Maximum tolerated doses for PER977 were 40 (rat) and 35 mg/kg (dog), and greater than 80 mg/kg (rat) for BAP. The no observable adverse effect level (NOAEL) for 14-day intravenous exposure to both rats and dogs was 20 mg/kg/d. For BAP, the NOAELs for 14-day intravenous exposure to rats and dogs were 5 and 20 mg/kg, respectively. Based on these results, a safe and conservative dose level of 19.4 mg/d was used for the PER977 first in human study.
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Surówka, Krzysztof, Ireneusz Maciejaszek, Kamila Walczak, Maria Walczycka, Barbara Surówka, Magdalena Rzepka, and Joanna Banaś. "Chemical composition, safety and quality attributes of traditional cottage sausage." Czech Journal of Food Sciences 37, No. 5 (October 31, 2019): 325–31. http://dx.doi.org/10.17221/135/2019-cjfs.
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The characteristic features of traditional cottage sausage were analysed. In addition, the extent to which manufacturers create product diversity on the market was investigated, along with potential health risks of the product to consumers. The samples had high overall sensory scores. The average level of fat slightly exceeded 28%, cholesterol content was in the range of 435.4–1220.3 mg/kg and salt content was 1.53–2.77%. Some manufacturers do not cure their product, but about 20% of them apply nitrites above the level of 150 mg/kg. Due to their relatively high pH level (5.76–6.60) and water activity (0.95–0.98), Polish cottage sausage can be a medium which encourages the growth of microorganisms; however, pathogenic bacteria were not found. Histamine was detected in only 42% of the samples, at the low level of 2.6 to 34.2 mg/kg. Principal Component Analysis (PCA) was applied and the dominant variables were specified for particular PCs.
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Patton, Aaron J., Daniel V. Weisenberger, Glenn A. Hardebeck, and Zachary J. Reicher. "Safety of Herbicides on ‘zenith’ Zoysiagrass Seedlings." Weed Technology 21, no. 1 (March 2007): 145–50. http://dx.doi.org/10.1614/wt-06-099.1.
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Improved cultivars of zoysiagrass established by seed are now available, but little is known about the safety of herbicides on zoysiagrass seedlings. Our objective was to determine the turf safety of various herbicides when applied from emergence to 4 wk after emergence (WAE) of ‘Zenith’ zoysiagrass. Oxadiazon (3.4 kg ai/ha), MSMA (2.3 kg ai/ha), and pronamide (1.1 kg ai/ha) did not reduce coverage 7 WAE when applied at emergence or later and caused only temporary discoloration of seedlings. Foramsulfuron (0.03 kg ai/ha) injured seedling zoysiagrass both years of testing and reduced cover in the final year. Fluazifop (0.07 kg ai/ha) caused significant injury in all 3 yr of the study and reduced coverage in the final year. Fenoxaprop (0.14 kg ai/ha) caused visible injury and reduction in zoysiagrass coverage in all 3 yr of the study. Our studies indicate pronamide, MSMA, or oxadiazon are the safest herbicides to use over Zenith zoysiagrass seedlings, and selection among these three depends on the primary weed species present.
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Marret, Jean-Baptiste, Claire Dupont-Lucas, Thierry Petit, Benjamin Menahem, Camille Godet, Philippe Ravasse, and Julien Rod. "Safety of laparoscopic fundoplication in children under 5 kg: a comparative study." Surgical Endoscopy 32, no. 10 (March 30, 2018): 4191–99. http://dx.doi.org/10.1007/s00464-018-6164-6.
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Amarillo, Maria, Ruth Martinez, Alexander Mallari, Cyndi Tai, and Vicente Belizario. "Efficacy and safety of 40 mg/kg and 60 mg/kg single doses of praziquantel in the treatment of schistosomiasis." Journal of Pediatric Infectious Diseases 03, no. 01 (July 28, 2015): 027–34. http://dx.doi.org/10.1055/s-0035-1556962.
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Hu, Xiao-bo, Yi Gong, Lei Li, Shao-ping Nie, Yuan-xing Wang, and Ming-yong Xie. "Safety Evaluation of Zinc Threoninate Chelate." International Journal of Toxicology 29, no. 4 (July 2010): 372–79. http://dx.doi.org/10.1177/1091581810367438.
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The acute toxicity of zinc threoninate chelate was assessed. The oral lethal dose 50% (LD50) was 2710 mg/kg in female rats and 3160 mg/kg in male rats. Genotoxicity was assessed by Ames test in Salmonella typhimurium strains TA97, TA98, TA100, and TA102, by bone marrow mouse micronucleus test and a sperm abnormality test with mice. Thirty-day repeat dose toxicity study was conducted at oral daily doses of 0, 42, 169, and 675 mg/kg in rats. Teratogenicity was assessed at the same daily dose in pregnant rats by gavage. No significant changes in body weight, food consumption, organ weight, relative organ weight, hematology, blood biochemistry, histopathology, behavior, mortality, sperm abnormality, mutagenicity, and micronucleus formation were observed and no clinical signs or adverse effects were detected. Zinc threoninate chelate had no significant teratogenic effect at a daily dose of 42 mg/kg.
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Wu, Wenbiao, and Yanling Sun. "Dietary safety evaluation of water hyacinth leaf protein concentrate." Human & Experimental Toxicology 30, no. 10 (December 10, 2010): 1514–20. http://dx.doi.org/10.1177/0960327110392085.
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It has been shown that water hyacinth leaf protein concentrate (WHLPC) is nutritionally and economically available for applications in food and feed, such as biscuits or seasonings industries, but, its dietary safety has never been studied. The dietary safety of WHLPC was therefore evaluated by analyzing the contents of total alkaloids, phenolic compounds, and heavy metals, followed by laboratory animal feeding test. The total alkaloid and phenolic contents of WHLPC were 18.7 mg/kg and 5.2 mg/kg, respectively. WHLPC contained non-detectable Cd, 0.04 mg/kg Cr, 0.001 mg/kg Pb, 0.002 mg/kg Pt, 0.001 mg/kg Pd, 0.003 mg/kg Sn, 0.002 mg/kg Hg, 0.01 mg/kg Ba, 0.001 mg/kg Ag, 0.006 mg/kg Sd, and 0.03 mg/kg Al. The LD50 of WHLPC in mice was more than 20.5 g/kg body weight (bw). After feeding mice for 7, 30, 60 or 90 days, either on diet containing WHLPC or a control diet of equivalent protein content, there were no significant differences in absolute body weight or weight gain of WHLPC-treated mice. The results of haematological analysis, histopathological evaluation, general dissection, and investigations of internal organs did not show any adverse effects from diet containing WHLPC. It was concluded that WHLPC is not acutely toxic and does not show sub-chronic in mice.
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Walsh, Thomas J., Timothy Driscoll, Peter A. Milligan, Nolan D. Wood, Haran Schlamm, Andreas H. Groll, Hasan Jafri, Antonio C. Arrieta, Nigel J. Klein, and Irja Lutsar. "Pharmacokinetics, Safety, and Tolerability of Voriconazole in Immunocompromised Children." Antimicrobial Agents and Chemotherapy 54, no. 10 (July 26, 2010): 4116–23. http://dx.doi.org/10.1128/aac.00896-10.
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ABSTRACT The pharmacokinetics of voriconazole in children receiving 4 mg/kg intravenously (i.v.) demonstrate substantially lower plasma exposures (as defined by area under the concentration-time curve [AUC]) than those in adults receiving the same therapeutic dosage. These differences in pharmacokinetics between children and adults limit accurate prediction of pediatric voriconazole exposure based on adult dosages. We therefore studied the pharmacokinetics and tolerability of higher dosages of an i.v.-to-oral regimen of voriconazole in immunocompromised children aged 2 to <12 years in two dosage cohorts for the prevention of invasive fungal infections. The first cohort received 4 mg/kg i.v. every 12 h (q12h), then 6 mg/kg i.v. q12h, and then 4 mg/kg orally (p.o.) q12h; the second received 6 mg/kg i.v. q12h, then 8 mg/kg i.v. q12h, and then 6 mg/kg p.o. q12h. The mean values for the AUC over the dosing interval (AUCτ) for 4 mg/kg and 6 mg/kg i.v. in cohort 1 were 11,827 and 22,914 ng·h/ml, respectively, whereas the mean AUCτ values for 6 mg/kg and 8 mg/kg i.v. in cohort 2 were 17,249 and 29,776 ng·h/ml, respectively. High interpatient variability was observed. The bioavailability of the oral formulation in children was approximately 65%. The safety profiles were similar in the two cohorts and age groups. The most common treatment-related adverse event was increased gamma glutamyl transpeptidase levels. There was no correlation between adverse events and voriconazole exposure. In summary, voriconazole was tolerated to a similar degree regardless of dosage and age; the mean plasma AUCτ for 8 mg/kg i.v. in children approached that for 4 mg/kg i.v. in adults, thus representing a rationally selected dosage for the pediatric population.
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Wright, Thomas F., Giulietta F. Brunetti, and Patrick Kennedy. "Lidocaine safety after saphenous vein tumescent anesthesia." Phlebology: The Journal of Venous Disease 34, no. 10 (March 14, 2019): 683–89. http://dx.doi.org/10.1177/0268355519836834.
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Objectives For endovenous thermal ablation of the saphenous veins, tumescent lidocaine anesthesia is often used. Unfortunately, information is sparse on the pharmacokinetics of lidocaine absorption and its maximum safe dose. The aim of this study was to evaluate plasma concentration of lidocaine on 12 lead electrocardiograms (ECGs) and symptoms over time after the administration of tumescent lidocaine during endovenous thermal ablation procedures in healthy volunteers. Methods An observational study of symptoms, 12 lead ECGs, and serum lidocaine levels were obtained following the administration of either 15 mg/kg lidocaine or 35 mg/kg lidocaine in the perivenous saphenous space under ultrasound guidance. Blood was drawn at regular intervals in heparinized tubes and spun at 3000 r/min for 10 min. The plasma lidocaine levels were plotted vs. time for statistical comparisons. Results With the 35 mg/kg dose, four of 11 participants developed symptoms of lidocaine toxicity at 40 min, which resolved by 180 min. The 35 mg/kg dose resulted in a mean serum lidocaine peak of 2.55 µg/ml at 60 min. The 15 mg/kg dose did not result in any symptoms of lidocaine toxicity, and it resulted in a serum lidocaine plateau of 0.85 µg/ml at 180 min. No significant changes were seen on the 12-lead ECG after the administration of lidocaine at either dose. Conclusions The 15 mg/kg total lidocaine dose did not cause symptoms and appears to be a safe lidocaine dosage for tumescent anesthesia for saphenous endovenous thermal ablations. The 35 mg/kg lidocaine dose is associated with lidocaine toxicity. More study on the maximal safe dose of lidocaine for endovenous thermal ablations is needed.
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Mashayekhi-Sardoo, Habibeh, Ramin Rezaee, and Gholamreza Karimi. "Nigella sativa (black seed) safety: an overview." Asian Biomedicine 14, no. 4 (September 20, 2020): 127–37. http://dx.doi.org/10.1515/abm-2020-0020.
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AbstractNigella sativa (commonly known as black seed or black cumin), from the family Ranunculaceae, is a plant that grows in countries bordering the Mediterranean Sea. This narrative review discusses the toxicological profile reported by short- to long-term studies that examined different extracts and oils of N. sativa seeds. Scientific databases including Web of Science, PubMed, Scopus, and Google Scholar were searched using appropriate keywords. LD50 for administered N. sativa seed fixed oil varied from 28.8 mL/kg to 3,371 mg/kg in mice, while 21 g/kg of aqueous, methanol, and chloroform extracts of N. sativa did not lead to any mortality. Subacute toxicity evaluations indicated that aqueous, methanol, and chloroform extracts of N. sativa at doses as high as 6 g/kg do not produce toxicity. Investigation of chronic toxicity found that 2 mL/kg of N. sativa fixed oil is slightly toxic. Cytotoxicity studies indicated that N. sativa chloroform and petroleum ether extracts are more cytotoxic than its other extracts. Although studies that assessed N. sativa toxicity generally introduced it as a safe medicinal herb, to draw a more definitive conclusion on its safety, more detailed studies must be conducted.
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AM. Jawad, Rehab, and Hayder B. Sahib. "Estimation the Safety of Parenteral Resveratrol in Mice." Iraqi Journal of Pharmaceutical Sciences ( P-ISSN 1683 - 3597 E-ISSN 2521 - 3512) 31, no. 1 (June 17, 2022): 167–75. http://dx.doi.org/10.31351/vol31iss1pp167-175.
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Resveratrol is polyphenolic compound has many biochemical and biological effects on several organs. Therefore, resveratrol can be used to treat many diseases. The aim was to evaluate resveratrol safety when used in a parenteral single bolus dose. This study was conducted on 60 mice (30 males and 30 females). Each male and female mice divided into 6 groups (five mice per group). All mice groups given 1% DMSO and five different doses of resveratrol (5, 2.5, 1.25, 0.625, 0.312) gm/kg intraperitonially given to five groups respectively. The mice were continuously monitored during 14 days. The number of deaths, changes in general behavior, changes in physiological activity, and signs of toxicity were reported. On day 15 blood was collected using a jugular vein puncture to obtain blood samples for hematological and biochemical analysis. All mice were euthanized under anesthesia. The heart, lung, liver, kidney, and gonads were dissected and sent for histopathological study. The result showed that at dose 0.312gm/kg neither signs of toxicity nor death were detected. The LD50 dose was 1.18 g/kg for female and 1.07 g/kg for male mice. The body weight change, biochemical and hematological assay, revealed that at doses 1.25 g/kg,0.625,0.312 g/kg for both sexes no significant changes had reported in comparison with a control group (p?0.05). Histopathological examination revealed that at doses 1.25 g/kg for both sexes no significant tissue changes had reported in comparison with a control group (p?0.05). In conclusion resveratrol has dose-dependent toxicity when used intraperitoneally in Swiss Albino mice and the non-observed adverse effect level at dose 0.312 g/kg.
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Asiedu-Gyekye, Isaac Julius, Seidu Abdulai Mahmood, Charles Awortwe, and Alexander Kwadwo Nyarko. "A Preliminary Safety Evaluation of Polyhexamethylene Guanidine Hydrochloride." International Journal of Toxicology 33, no. 6 (October 29, 2014): 523–31. http://dx.doi.org/10.1177/1091581814553036.
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Polyhexamethylene guanidine hydrochloride (PHMGH) is used worldwide as an antimicrobial agent with broad spectra of activity and also for treating pool water. This non-GLP preliminary study aims at investigating in a subchronic toxicity study possible effects at supra-optimal doses of this biocide. Both acute and subchronic toxicity studies were conducted. LD50 for PHMGH was estimated to be 600 mg/kg (ie LC50 2 ml of 7.5% solution) when administered as a single dose by gavage via a stomach tube in accordance with the expected route of administration. The acute studies showed that the median lethal dose (LD50) of 600 mg/kg was accompanied by signs of neurotoxicity. Haematological and biochemical parameters of subchronic toxicity studies were non-significant. Subchronic doses of 0.006 mg/kg, 0.012 mg/kg and 0.036 mg/kg were administered. 20% of the animals at a dose of 0.006 mg/kg and 0.036 mg/kg showed mild degrees of hydropic changes in proximal tubules while 10% of animals at all the doses had their liver tissues showing local areas of mild pericentral hepatocytes degeneration. PHMGH did not produce any major organ defect with regard to the kidney, heart, and liver. The LD50 was much higher than the recommended dosage by a factor of about 50,000. The recommended residual concentration is far less than the median lethal dose using rats as test subjects. These results could serve as a basis for investigating the full toxicological profile if it is to be used for the treatment of raw water to make it potable.
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Hascoet, S., C. Bautista, and A. Fraisse. "Feasibility, safety and efficacy of atrial flow regulator in children under 10 kg." Archives of Cardiovascular Diseases Supplements 14, no. 3-4 (September 2022): 249. http://dx.doi.org/10.1016/j.acvdsp.2022.07.062.
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Moise, Pamela A., Ellie Hershberger, Maria I. Amodio-Groton, and Kenneth C. Lamp. "Safety and Clinical Outcomes when Utilizing High-Dose (≥8 mg/kg) Daptomycin Therapy." Annals of Pharmacotherapy 43, no. 7-8 (July 2009): 1211–19. http://dx.doi.org/10.1345/aph.1m085.
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Mir, Olivier, Jérôme Alexandre, Romain Coriat, Stanislas Ropert, Pascaline Boudou-Rouquette, Thach Bui, Jeanne Chapron, Jean-Philippe Durand, Daniel Dusser, and François Goldwasser. "Safety of bevacizumab 7.5 mg/kg infusion over 10 minutes in NSCLC patients." Investigational New Drugs 30, no. 4 (May 26, 2011): 1756–60. http://dx.doi.org/10.1007/s10637-011-9690-9.
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Slovak, Jennifer E., and Nicolas F. Villarino. "Safety of oral and intravenous mycophenolate mofetil in healthy cats." Journal of Feline Medicine and Surgery 20, no. 2 (February 16, 2017): 184–88. http://dx.doi.org/10.1177/1098612x17693521.
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Objectives The aim of this study was to evaluate the safety and clinical effects of intravenous (IV) and oral mycophenolate mofetil (MMF) in healthy cats. Methods A total of 24 healthy adult cats weighing >3.5 kg were either given IV MMF (over a 2 h infusion) or oral MMF. The dosages used were as follows: 5 mg/kg IV once (n = 2), 10 mg/kg q12h IV for 1 day (n = 1), 20 mg/kg q12h IV for 1 day (n = 6) and 10 mg/kg q12h IV for 3 days (n = 5). Blood was collected from each cat at intervals of up to 12 h from the last dose for analysis purposes. Oral MMF was given at 10 mg/kg q12h for 7 days (n = 3), 15 mg/kg q12h for 7 days (n = 3) and 15 mg/kg q8h for 7 days (n = 4). Results Side effects to MMF were minimal. There was no anorexia or vomiting noted in any of the cats during or after IV medication administration. Only 4/14 cats had diarrhea from 12–48 h after IV administration. There was hyporexia in 1/10 cats given oral MMF and no vomiting noted. In 5/10 cats given oral MMF, there was diarrhea between days 2 and 7 of the study. Conclusions and relevance Cats tolerate MMF at an IV dose of 10 mg/kg q12h for 3 days and an oral dose ⩽15 mg/kg q12h for up to 7 days. There seems to be a dose-dependent incidence of gastrointestinal side effects. MMF may be a useful alternative immunosuppressant to be considered for use in some cats.
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Piskernik, Christina, Barbara Dietrich, Susan Kubik, Tanja Ruthsatz, Friedrich Scheiflinger, Hans Peter Schwarz, and Eva-Maria Muchitsch. "Preclinical Safety of Baxter's Recombinant ADAMTS13." Blood 120, no. 21 (November 16, 2012): 3381. http://dx.doi.org/10.1182/blood.v120.21.3381.3381.
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Abstract Abstract 3381 Baxter is currently developing a recombinant ADAMTS13 (rADAMTS13, a disintegrin and metalloproteinase with a thrombospondin type 1 motif, member 13) product for treatment, and routine prophylaxis of acute episodes of thrombotic thrombocytopenic purpura (TTP) in patients with ADAMTS13 deficiency. TTP is a rare, life-threatening microvascular disease characterized by single or recurrent episodes of thrombocytopenia, microangiopathic haemolytic anaemia and widespread microvascular thrombosis, which leads to the ischemic damage of multiple organs. To characterize the safety and the no observed adverse effect level (NOAEL) of Baxter's rADAMTS13, a 1-month repeat dose toxicity study in rats, an escalating dose and pilot 4-week repeat dose toxicity study in cynomolgus monkeys, and a 1-month repeat dose toxicity study including cardiovascular/pulmonary safety pharmacology in cynomolgus monkeys was conducted. Species suitability was shown by demonstrating that human rADAMTS13 can cleave monkey and rat VWF in vitro and in vivo under native conditions to present a worst case scenario for repeat dose toxicity studies. A local tolerance study was conducted in rabbits. Baxter's rADAMTS13 was well tolerated in rats at doses of 80, 400 and 800 FRETS-U/kg administered every third day for one month. Thus, the NOAEL in rats was the highest dose of 800 FRETS-U/kg. In cynomolgus monkeys, no adverse effects were detected at 800 FRETS-U/kg after intravenous treatment with rADAMTS13 once a week for 5 weeks (pilot repeat dose study). The NOAEL for the escalating dose phase of the study was 1790 FRETS-U/kg. Treatment of cynomolgus monkeys with bolus injection of Baxter's rADAMTS13 at doses of 80, 200, and 400 FRETS-U/kg once a week for 29 days did not reveal adverse findings. Thus, the NOAEL for this study was the highest dose of 400 FRETS-U/kg. As expected for a heterologous human protein drug, repeat doses of rADAMTS13 resulted in the formation of anti-drug antibodies specific for human ADAMTS13 and in neutralising human ADAMTS13 activity in animal models. No injection site reactions were observed in animals of either species. rADAMTS13 was well tolerated after intravenous (intended clinical administration route), intraarterial and paravenous administration in rabbits. In conclusion, Baxter's rADAMTS13 was well tolerated in rats, monkeys and rabbits, with no toxicity observed even at the highest dose levels. Disclosures: Piskernik: Baxter Innovations GmbH: Employment. Dietrich:Baxter Innovations GmbH: Employment. Kubik:Baxter Innovations GmbH: Employment. Ruthsatz:Baxter Innovations GmbH: Employment. Scheiflinger:Baxter Innovations GmbH: Employment. Schwarz:Baxter Innovations GmbH: Employment. Muchitsch:Baxter Innovations GmbH: Employment.
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van Schaik, Ivo N., Orell Mielke, Vera Bril, Nan van Geloven, Hans-Peter Hartung, Richard A. Lewis, Gen Sobue, et al. "Long-term safety and efficacy of subcutaneous immunoglobulin IgPro20 in CIDP." Neurology - Neuroimmunology Neuroinflammation 6, no. 5 (July 3, 2019): e590. http://dx.doi.org/10.1212/nxi.0000000000000590.
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ObjectiveTo investigate the long-term safety and efficacy of weekly subcutaneous IgPro20 (Hizentra, CSL Behring) in chronic inflammatory demyelinating polyneuropathy (CIDP).MethodsIn a 48-week open-label prospective extension study to the PATH study, patients were initially started on 0.2 g/kg or on 0.4 g/kg weekly and—if clinically stable—switched to 0.2 g/kg weekly after 24 weeks. Upon CIDP relapse on the 0.2 g/kg dose, 0.4 g/kg was (re)initiated. CIDP relapse was defined as a deterioration by at least 1 point in the total adjusted Inflammatory Neuropathy Cause and Treatment score.ResultsEighty-two patients were enrolled. Sixty-two patients initially received 0.4 g/kg, 20 patients 0.2 g/kg weekly. Seventy-two received both doses during the study. Sixty-six patients (81%) completed the 48-week study duration. Overall relapse rates were 10% in 0.4 g/kg–treated patients and 48% in 0.2 g/kg–treated patients. After dose reduction from 0.4 to 0.2 g/kg, 51% (27/53) of patients relapsed, of whom 92% (24 of 26) improved after reinitiation of the 0.4 g/kg dose. Two-thirds of patients (19/28) who completed the PATH study without relapse remained relapse-free on the 0.2 g/kg dose after dose reduction in the extension study. Sixty-two patients had adverse events (AEs) (76%), of which most were mild or moderate with no related serious AEs.ConclusionsSubcutaneous treatment with IgPro20 provided long-term benefit at both 0.4 and 0.2 g/kg weekly doses with lower relapse rates on the higher dose. Long-term dosing should be individualized to find the most appropriate dose in a given patient.Classification of evidenceThis study provides Class IV evidence that for patients with CIDP, long-term treatment with SCIG beyond 24 weeks is safe and efficacious.
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Patel, Girishchandra B., Hongyan Zhou, Amalia Ponce, and Wangxue Chen. "Safety Evaluation of Calcium Administered Intranasally to Mice." International Journal of Toxicology 28, no. 6 (September 16, 2009): 510–18. http://dx.doi.org/10.1177/1091581809347388.
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Calcium, a component of approved human vaccines administered via systemic routes, has a good safety profile. Recently, intranasally administered vaccines containing calcium have shown promise in generating mucosal immune responses in animal models. However, the safety of intranasally administered calcium is unknown. This study evaluates the safety of intranasally administered calcium at 2- to 13-fold higher doses than used in experimental vaccines. At a calcium dose of 22 mg/kg, 80% of the Balb/c and 20% of the C57BL/6 mice die within the first 24 hours. At 11.0 mg/kg, there is no overt toxicity in either strain, based on body weight, clinical scores, blood chemistry, and histopathology of major organs at 7 days post administration. In C57BL/6 mice, apart from acute and subacute inflammation in the lungs at up to 3 days post administration, especially at the 22-mg/kg dose, there is no overt toxicity. Doses of calcium up to 11 mg/kg appear to be safe in a mouse model.
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Wright, Steven D., Anil Shrestha, Robert B. Hutmacher, Gerardo Banuelos, Kelly A. Hutmacher, Sonia I. Rios, Michelle Dennis, Katherine A. Wilson, and Sara J. Avila. "Glufosinate Safety in WideStrike® Acala Cotton." Weed Technology 28, no. 1 (March 2014): 104–10. http://dx.doi.org/10.1614/wt-d-13-00039.1.
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WideStrike® Acala cotton is a two-gene, in-plant trait that provides broad-spectrum and season-long control of lepidopteran insect pests, and the varieties available in California also have resistance to glyphosate. There have been indications that WideStrike cotton has some glufosinate tolerance as well, so the level of tolerance to glufosinate needed to be ascertained. A 2-yr (2008 and 2009) study was conducted in California to evaluate the potential crop injury caused by three different rates (0.59, 0.88, and 1.76 kg ai ha−1) of glufosinate–ammonium at four different growth stages (cotyledon, 2-node, 5- to 6-node, and 18- to 19-node stages) of WideStrike Acala cotton. The effects of these treatments on the cotton plants and yield were closely monitored. Glyphosate at 1.54 kg ae ha−1 was applied at all cotton growth stages as a standard application, and a nontreated control was included. The greatest level of injury (58%) was observed with the highest rate of glufosinate applied at both the cotyledon and the two-node stage of cotton. However, injury was less than 10% following glufosinate at 0.59 kg ha−1 applied at the 18- to 19-node stage. The level of injury increased with the higher application rate of glufosinate at all crop growth stages. In 2008 and 2009, the glufosinate treatments had no effect on cotton lint yield. Therefore, the study showed that glufosinate can be applied safely topically at 0.59 kg ha−1 at the cotyledon- to 2-node stage or as POST-directed spray between the 5- to 19-node stages. Although injury occurred at this rate, the plants recovered within 2 to 3 wk of the treatment. Increasing glufosinate rates beyond 0.59 kg ha−1 can increase the possibility of greater crop injury.
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Kim, Eun-Joo, Eun-Kyung Park, and Kwee-Hyun Suh. "Safety pharmacology of sibutramine mesylate, an anti-obesity drug." Human & Experimental Toxicology 24, no. 3 (March 2005): 109–19. http://dx.doi.org/10.1191/0960327105ht510oa.
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Sibutramine mesylate is a new anti-obesity drug. It is a crystalline salt of sibutramine developed to improve the solubility of sibutramine hydrochloride. Methanesulfonic acid was used as a salt-forming acid instead of hydrochloric acid, resulting in a greatly improved solubility of 1000 mg/mL in water. Sibutramine mesylate was administered orally to ICR mice, Sprague / respiratory system and the other organ systems. Following administration of sibutramine mesylate, spontaneous locomotor activity was significantly increased from 120 min to 24 hours at 3.45 mg/kg and from 30 min to 24 hours at 11.50 mg/kg. Furthermore, there were a decrease in hexobarbitalinduced sleep time, an increase in respiratory rate at 120 min, increases in intestinal transport capacity and gastric pH at 11.50 mg/kg, and decreases in gastric / Dawley rats, and beagle dogs at dose levels of 1.15, 3.45, and 11.50 mg/kg to measure its effects on the central nervous system (CNS), general behaviour, cardiovascular volume and total acidity at 3.45 and 11.50 mg/kg. However sibutramine mesylate caused no effects on general behaviour, motor coordination, body temperature, analgesia, convulsion, blood pressure, heart rate, electrocardiogram, cardiac functions of the isolated rat heart, isolated smooth muscles and renal function. Based on the above results, it was concluded that sibutramine mesylate caused effects on the spontaneous locomotor activity, hexobarbital-induced sleep time, respiration, gastrointestinal transport, and gastric secretion at a dose level of 3.45 mg/kg or greater but caused no effects on other general pharmacological reactions.
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Kotelevych, V. A., I. A. Volkivskyi, O. V. Pinskyi, and L. M. Davydenko. "Food quality and safety as the keys to the health of future generations." Scientific Messenger of LNU of Veterinary Medicine and Biotechnologies 23, no. 103 (November 27, 2021): 179–86. http://dx.doi.org/10.32718/nvlvet10325.
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The material for the research were publications of scientists, reporting documentation of ZHRSLSPS, RSLSPS, SLVSE of Zhytomyr and Zhytomyr region, food samples. Radiological studies were performed on the device USC Gamma-plus № 0502 BG. The content of radionuclides in mushrooms was determined on RUG-91. In 2020, 210183 samples were tested, including 90 in excess. As in previous years, the excess was found in 19 samples of milk from the Narodytsya district (103–180 Bq/kg). The gifts of the forest remain the most polluted. The specific activity of 3 samples of fresh mushrooms from Novohrad-Volynskyi district was 610 Bq/kg, 642 Bq/kg, and 819 Bq/kg (with DR 500 Bq/kg), 4 samples from Yemilchyn district – 531–761 Bq/kg, 2 samples from Luhyny district – 760 Bq/kg and 827 Bq/kg. The most significant number of exceedances in the level of contamination of fresh mushrooms was found in Narodytsky, Ovruch, Malyn, and Olevsk districts, slightly less – in Luhyny. In particular, of the 25 samples of fresh mushrooms from Narodytsya district, 23 (621–2000 Bq/kg, DR exceeded 1.2–4 times) were detected, 28 % of fresh mushroom samples in Ovruch district were exceeded at 530–916 Bq/kg, of the 48 samples from Olevsk district exceedances were in 3 samples and, accordingly, their specific activity was at the level of 983 Bq/kg, 1994 Bq/kg and 2125 Bq/kg, i.e., 1.1, 3.9 and 4 times higher for DR-2006. In Malyn district, 50 % of samples of fresh mushrooms showed an excess of 631–1450 Bq/kg (1.3–2.9 times). In the Luhyny district, the excess was found in 18 % of samples (760 Bq/kg – 827 Bq/kg). The specific activity of samples of dried mushrooms from Novohrad-Volynskyi district was 2725 and 3018 Bq/kg, respectively, Yemilchynsky – 2608–3080 Bq/kg, Ovruch – 2820 Bq/kg and 2850 Bq/kg, Narodytsky – 3425 Bq/kg. The specific activity of 2 samples of wild animal meat from Narodytskyi district was 800 and 1400 Bq/kg (exceeding 2–3.5 times), 1 sample from Ovruch – 433 Bq/kg. Of the 109 samples of beekeeping products studied during this period, exceedances were detected in 1.8 %, the specific activity was 264 Bq/kg (Narodytskyi district) and 1920 Bq/kg (Ovruch district), respectively. In 2020, no excesses were found in samples of other products. Given that the consumption of food, even with low specific activity, leads to an increase in internal exposure, the research results indicate a threat to the health of present and future generations and the need for decision-making at the state level.
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Hamdy, Mohamed, Mohamed A. Bayoumi, Ali E. Abuelezz, and Alaaeldin A. Eltawil. "Developing the NIS solid density hydrostatic weighing system up to 20 kg." International Journal of Metrology and Quality Engineering 11 (2020): 8. http://dx.doi.org/10.1051/ijmqe/2020006.
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This paper presents a developed design and construction to improve the performance and increasing the density measuring capability of the previous Hydrostatic Weighing Apparatus (HWA-NIS) at the National Institute of Standards (NIS) up to 20 kg. The previous (HWA-NIS) has been constructed up to 10 kg on 2014. The 2-Positions mass handler in the previous (HWA) was developed with 4-Positions pentagon shape to be able to make handling for individual masses in a group at once, when transferring the traceability from the primary standard “the Silicon Sphere” to the standard masses in the density scale weighing process. The weighing pan in the previous (HWA) was developed with four suspension wires with a diameter of 0.3 mm each, leads to reduce the surface tension affect on the measurement uncertainty by factor four times. The density of the standard masses in the range from 2 kg up to 20 kg were measured with an improved expanded uncertainty from 0.150 kg/m3 to 0.078 kg/m3 respectively due to reducing the effect of surface tension via the developed design of the weighing pan.
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Bojanic, I., S. Mazic, M. Lukic, L. J. Rajic, G. Jakovljevic, and B. Golubic Cepulic. "Efficiency and safety of large volume leukapheresis in small children up to 15 kg." Transfusion and Apheresis Science 50 (May 2014): S10. http://dx.doi.org/10.1016/s1473-0502(14)50020-1.
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Del Vecchio, Michele, Lorenza Di Guardo, Paolo A. Ascierto, Antonio M. Grimaldi, Vanna Chiarion Sileni, Jacopo Pigozzo, Virginia Ferraresi, et al. "Efficacy and safety of ipilimumab 3mg/kg in patients with pretreated, metastatic, mucosal melanoma." European Journal of Cancer 50, no. 1 (January 2014): 121–27. http://dx.doi.org/10.1016/j.ejca.2013.09.007.
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Mori, Etsuro. "Safety and efficacy of 0.6 mg/kg rt-PA: optimum rt-PA dose revisited." Annals of the New York Academy of Sciences 1268, no. 1 (September 2012): 108–12. http://dx.doi.org/10.1111/j.1749-6632.2012.06689.x.
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Modeste, Virginie, Alizée Brient, Catherine Thirion-Delalande, Roy Forster, Corinne Aguenou, Hywel Griffiths, and Olivier Cagnac. "Safety evaluation of Galdieria high-protein microalgal biomass." Toxicology Research and Application 3 (January 1, 2019): 239784731987927. http://dx.doi.org/10.1177/2397847319879277.
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Protealg® is the dried and ground whole biomass of Galdieria sulphuraria, a microalga naturally rich in protein and phycocyanin, and contains carotenoids. It is expected that Protealg will be consumed as a food ingredient or supplement by the general public. The safety of Protealg was evaluated in an Ames bacterial reverse mutation test, in vitro mammalian cell micronucleus test, and 13-week oral toxicity study in rats at the dose levels of 500, 2000, and 5000 mg/kg/day. The 13-week toxicity study included a 4-week treatment-free period to evaluate recovery. A functional observation battery and ophthalmology examinations were performed, and hematology, blood biochemistry, thyroid hormone, and urinalysis parameters were determined. Seminology parameters and estrus cycle staging were investigated. A macroscopic necropsy examination was performed and tissues were examined microscopically. Protealg showed no evidence of mutagenicity or clastogenic activity. It was well tolerated by rats and no clinical findings indicative of toxicity were observed. There were no significant findings in the in-life or post-mortem investigations. In conclusion, no toxicity was observed after administration of Protealg at dose levels up to 5000 mg/kg/day to rats for 13 weeks, supporting the safety of Protealg for use as a high protein food supplement. The NOAEL was established as 5000 mg/kg/day. Allowing for a margin of exposure of 100-fold, the corresponding anticipated daily intake will be 50 mg/kg/day equivalent to 3.5 g/day for a 70 kg subject. Incorporation levels in various foods will be defined on the basis of appropriate exposure estimations using official recommendations.
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Yogendrakumar, Vignan, Leonid Churilov, Peter J. Mitchell, Timothy J. Kleinig, Nawaf Yassi, Vincent Thijs, Teddy Y. Wu, et al. "Safety and Efficacy of Tenecteplase in Older Patients With Large Vessel Occlusion." Neurology 98, no. 12 (January 11, 2022): e1292-e1301. http://dx.doi.org/10.1212/wnl.0000000000013302.
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Background and ObjectivesDetailed study of tenecteplase (TNK) in patients older than 80 years is limited. The objective of our study was to assess the safety and efficacy of TNK at 0.25 and 0.40 mg/kg doses in patients older than 80 years with large vessel occlusion.MethodsWe performed a pooled analysis of the EXTEND-IA TNK randomized controlled trials (n = 502). Patients were adults presenting with ischemic stroke due to occlusion of the intracranial internal carotid, middle cerebral, or basilar artery presenting within 4.5 hours of symptom onset. We compared the treatment effect of TNK 0.25 mg/kg, TNK 0.40 mg/kg, and alteplase 0.90 mg/kg, stratifying for patient age (>80 years). Outcomes evaluated include 90-day modified Rankin Scale (mRS) score, all-cause mortality, and symptomatic ICH. Treatment effect was adjusted for baseline NIH Stroke Score, age, and time from symptom onset to puncture via mixed effects proportional odds and logistic regression models.ResultsIn patients >80 years (n = 137), TNK 0.25 mg/kg was associated with improved 90-day mRS (median 3 vs 4, adjusted common odds ratio (acOR) 2.70, 95% CI 1.23–5.94) and reduced mortality (acOR 0.34, 95% CI 0.13–0.91) vs 0.40 mg/kg. TNK 0.25 mg/kg was associated with improved 90-day mRS (median 3 vs 4, acOR 2.28, 95% CI 1.03–5.05) vs alteplase. No difference in 90-day mRS or mortality was detected between alteplase and TNK 0.40 mg/kg. Symptomatic ICH was observed in 4 patients treated with TNK 0.40 mg/kg, 1 patient treated with alteplase, and 0 patients treated with TNK 0.25 mg/kg. In patients ≤80 years, no differences in 90-day mRS, mortality, or symptomatic ICH were observed among TNK 0.25 mg/kg, alteplase, and TNK 0.40 mg/kg.DiscussionTNK 0.25 mg/kg was associated with improved 90-day mRS and lower mortality in patients older than 80 years. No differences among the doses were observed in younger patients.Trial Registration InformationNCT02388061, NCT03340493.Classification of EvidenceThis study provides Class II evidence that tenecteplase 0.25 mg/kg given before endovascular therapy in patients >80 years old with large vessel occlusion stroke is associated with better functional outcomes at 90 days and reduced mortality when compared to tenecteplase 0.40 mg/kg or alteplase 0.90 mg/kg.
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Shang, Lijun, Junyan Zhou, Jiayu Tu, Xiangfang Zeng, and Shiyan Qiao. "Evaluation of Effectiveness and Safety of Microcin C7 in Weaned Piglets." Animals 12, no. 23 (November 24, 2022): 3267. http://dx.doi.org/10.3390/ani12233267.
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The effects and safety of dietary supplementation with Microcin C7 (C7) were evaluated in 216 weaned piglets. The pigs were given a control corn–soybean meal basal diet or C7 diet (control diet supplemented with 250, 500, 750, 1000, or 5000 mg C7/kg diets). Compared with the control group, the 500 mg/kg C7 supplementation group had better intestinal morphological indicators (p < 0.05), which may help maintain intestinal epithelial function and increase the growth performance (p < 0.05) and apparent total tract digestibility (p < 0.05). The diarrhea indexes of the 250, 500, and 750 mg/kg groups were significantly lower than that of the control group at 0–28 d (p < 0.05), and the 500 mg/kg group had the lowest diarrhea indexes (linear and quadratic, p < 0.05). A comprehensive analysis showed that microbial structure was significantly correlated with the degree of diarrhea, and the diarrhea-alleviating effect of C7 may be related to its selective regulation of specific microbial taxa. The 250 and 500 mg/kg C7 supplementation also significantly improved several immune indices of piglets (p < 0.05). Compared with the control diet, 5000 mg/kg C7 supplementation had no significant adverse effect on all parameters. Overall, the 250–500 mg/kg dose had the best effect, and the highest dose (5000 mg/kg) posed no toxicity risk. Therefore, C7 appears safe for use as an alternative to antibiotic growth promoters in weaned piglets.
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Kerr, Janet S., Sheila Galloway, Armando Lagrutta, Michael Armstrong, Thomas Miller, Victoria M. Richon, and Paul A. Andrews. "Nonclinical Safety Assessment of the Histone Deacetylase Inhibitor Vorinostat." International Journal of Toxicology 29, no. 1 (November 10, 2009): 3–19. http://dx.doi.org/10.1177/1091581809352111.
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Vorinostat (SAHA, Zolinza), a histone deacetylase inhibitor, is assessed in nonclinical studies to support its approval for cutaneous T-cell lymphoma. Vorinostat is weakly mutagenic in the Ames assay; is clastogenic in rodent (ie, CHO) cells but not in normal human lymphocytes; and is weakly positive in an in vivo mouse micronucleus assay. No effects are observed on potassium ion currents in the hERG assay up to 300 μM (safety margin ~300-fold the ~1 μM serum concentration associated with the 400 mg/d maximum recommended human dose. No rat respiratory or central nervous system effects are found at 150 mg/kg (>2-fold maximum recommended human dose). No cardiovascular effects, including effects on QTc interval, are observed after a single oral dose (150 mg/kg) in dogs. Vorinostat is orally dosed daily in rats (controls, 20, 50, or 150 mg/kg/d) and dogs (controls, 60, 80, or 100/125/160 mg/kg/d) for 26 weeks with a 4-week recovery. Rat vorinostat-related adverse findings are decreased food consumption, weight loss, and hematologic changes; a no observed adverse effects level is not established. In dogs, adverse effects are primarily gastrointestinal; the no observed adverse effects level is 60 mg/kg/d (~6-fold maximum recommended human dose). Toxicities are reversible and can be monitored in the clinic.
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Wiseman, Gregory, Peter Conti, Katie Vo, Russell J. Schilder, Paul Foster, Leo I. Gordon, Christos Emmanouilides, Dan Silverman, Thomas E. Witzig, and Arturo Molina. "Evaluation of Baseline Body-Weight Dosing of Yttrium 90 (90Y) Ibritumomab Tiuxetan (Zevalin®) Radioimmunotherapy in Patients with Relapsed or Refractory B-Cell Non-Hodgkin’s Lymphoma (NHL)." Blood 104, no. 11 (November 16, 2004): 2634. http://dx.doi.org/10.1182/blood.v104.11.2634.2634.
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Abstract Background: As the first radiolabled monoclonal antibody approved for the treatment for the treatment of cancer, yttrium 90 (90Y) ibritumomab tiuxetan (Zevalin®) achieves both high response rates and durable remissions in patients with relapsed or refractory, low-grade, follicular, or transformed B-cell NHL. Because of the stability of 90Y ibritumomab tiuxetan and its favorable pharmacokinetic profile (ie, predictable urinary clearance and absence of dehalogenation), dosing is based on patient weight and platelet counts. Yttrium 90 ibritumomab tiuxetan is typically delivered at a dose of 0.4 mCi/kg (in patients with platelets >150,000/mm3) or 0.3 mCi/kg (in patients with platelets ≤150,000/mm3) to a maximum recommended dose (MRD) of 32 mCi. However, patients >80 kg with platelet counts exceeding 150,000/mm3 may receive a lower drug concentration (ie, <0.4 mCi/kg 90Y) as a result of dose capping. We evaluated whether the 32 mCi dose cap influences the safety or efficacy of ibritumomab tiuxetan therapy in patients >80 kg. Methods: Efficacy and safety data were collected for patients from 3 registrational trials that received either 0.4 mCi/kg 90Y (patients ≤80 kg) or 32 mCi 90Y (patients >80 kg). Results: Clinical responses in 170 patients were evaluated. Patients ≤80 kg (n = 103) had a median weight of 70 kg (range, 45–80 kg) versus a median weight of 95 kg (range, 81–159) for patients >80 kg (n = 67). Gender (41% M vs 73% M, respectively; P <.01) was the only significantly different baseline characteristic between the ≤80 kg and >80 kg groups. Similar efficacy and safety results were reported for both subsets of patients. Overall response rates of 79% and 70% were observed for patients ≤80 kg and >80 kg, respectively (P =.27); and no significant differences were seen in complete response rates (28% vs 34%, respectively; P =.40). Median TTP (8.9 months vs 9.5 months; P =.53) and median DR (8.5 months vs 11.5 months; P =.34) were equivalent between the 2 weight-based groups. In addition, there were no statistically significant differences in safety measures including grade 3/4 nonhematologic adverse events, neutropenia, thrombocytopenia, or anemia. Conclusions: As a consequence of dose capping at an MRD of 32 mCi, 39% of patients received a lower dose/kg of 90Y ibritumomab tiuxetan. However, despite the difference in dose administered on a unit of body weight basis, the efficacy and safety results were similar between patients ≤80 kg and >80 kg. We conclude that the 32 mCi dose cap does not influence the efficacy or safety profile of 90Y ibritumomab tiuxetan for patients >80 kg.
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Ananda, Dhea Nuni, Rizal Hanifi, and Aa Santosa. "Perancangan dan Analisis Tegangan pada Desain Footrest Sepeda Motor Menggunakan Autodesk Inventor." Jurnal Teknik Mesin 14, no. 1 (March 3, 2021): 1–5. http://dx.doi.org/10.30630/jtm.14.1.479.
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Motorbikes are widely chosen by the public as a mode of transportation in modern times, one of which is the automatic scooter type motorcycle. Visually, the matic scooter type motorcycle components have a nice and attractive shape, but this shape does not necessarily guarantee its safety. Not a few of these components have failed (broken) as happened to the footrest. Footrest is a component of a motorcycle vehicle that functions as a footrest for motorcycle passengers. Every different type of motorbike, the footrest shape is also different. The purpose of this study is to design a footrest design and analyze it with the help of software to obtain a footrest design that has a high safety factor value. The design of the motorcycle footrest design produces 3 different designs. The three designs were analyzed using the Autodesk Inventor 2017 software stress by providing a static load of 20 Kg and 90 Kg. From the analysis, the minimum safety factor value obtained from each footrest design against a load of 20 kg in design 1 is 13.42, design 2 is 5.7, and design 3 is 7.93. While the minimum safety factor value generated from each footrest design against a load of 90 kg in design 1 is 2.98, design 2 is 1.27, and design 3 is 1.76. Based on the results of the safety factor analysis carried out, the three designs are safe enough to withstand loads of 20 Kg and 90 Kg. But design 1 is safer because the resulting value of the safety factor is higher than the three designs, which is 2.98 to withstand a load of 90 Kg.
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Conze, DB, J. Crespo-Barreto, and CL Kruger. "Safety assessment of nicotinamide riboside, a form of vitamin B3." Human & Experimental Toxicology 35, no. 11 (July 11, 2016): 1149–60. http://dx.doi.org/10.1177/0960327115626254.
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Nicotinamide riboside (NR) is a naturally occurring form of vitamin B3 present in trace amounts in some foods. Like niacin, it has been shown to be a precursor in the biosynthesis of nicotinamide adenine dinucleotide (NAD+). The safety of Niagen™, a synthetic form of NR, was determined using a bacterial reverse mutagenesis assay (Ames), an in vitro chromosome aberration assay, an in vivo micronucleus assay, and acute, 14-day and 90-day rat toxicology studies. NR was not genotoxic. There was no mortality at an oral dose of 5000 mg/kg. Based on the results of a 14-day study, a 90-day study was performed comparing NR at 300, 1000, and 3000 mg/kg/day to an equimolar dose of nicotinamide at 1260 mg/kg/day as a positive control. Results from the study show that NR had a similar toxicity profile to nicotinamide at the highest dose tested. Target organs of toxicity were liver, kidney, ovaries, and testes. The lowest observed adverse effect level for NR was 1000 mg/kg/day, and the no observed adverse effect level was 300 mg/kg/day.
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Michael, Claudia, Uta Bierbach, Katrin Frenzel, Thoralf Lange, Nadezda Basara, Dietger Niederwieser, Christine Mauz-Körholz, and Rainer Preiss. "Voriconazole Pharmacokinetics and Safety in Immunocompromised Children Compared to Adult Patients." Antimicrobial Agents and Chemotherapy 54, no. 8 (June 14, 2010): 3225–32. http://dx.doi.org/10.1128/aac.01731-09.
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ABSTRACT The aim of this study was to investigate the pharmacokinetics and safety of voriconazole after intravenous (i.v.) administration in immunocompromised children (2 to 11 years old) and adults (20 to 60 years old) who required treatment for the prevention or therapy of systemic fungal infections. Nine pediatric patients were treated with a dose of 7 mg/kg i.v. every 12 h for a period of 10 days. Three children and 12 adults received two loading doses of 6 mg/kg i.v. every 12 h, followed by a maintenance dose of 5 mg/kg (children) or 4 mg/kg (adults) twice a day during the entire study period. Trough voriconazole levels in blood over 10 days of therapy and regular voriconazole levels in blood for up to 12 h postdose on day 3 were examined. Wide intra- and interindividual variations in plasma voriconazole levels were noted in each dose group and were most pronounced in the children receiving the 7-mg/kg dose. Five (56%) of them frequently had trough voriconazole levels in plasma below 1 μg/ml or above 6 μg/ml. The recommended dose of 7 mg/kg i.v. in children provides exposure (area under the concentration-time curve) comparable to that observed in adults receiving 4 mg/kg i.v. The children had significantly higher C max values; other pharmacokinetic parameters were not significantly different from those of adults. Voriconazole exhibits nonlinear pharmacokinetics in the majority of children. Voriconazole therapy was safe and well tolerated in pediatric and adult patients. The European Medicines Agency-approved i.v. dose of 7 mg/kg can be recommended for children aged 2 to <12 years.
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Ardhirakmanto, M. Ayub, Sri Rahayuningsih, and Ana Komari. "Pengendalian Persediaan Bahan Baku Pada Industri Tenun Ikat “Medali Mas” Kediri." JURMATIS : Jurnal Ilmiah Mahasiswa Teknik Industri 2, no. 2 (August 31, 2020): 75. http://dx.doi.org/10.30737/jurmatis.v2i2.949.
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Tenun Ikat Medali Mas Industry has long been producing woven cloth in various models and patterns. Problems faced by researchers regarding the supply of raw materials, due to the absence of controlling the amount of inventory of raw materials needed specifically, while the company is faced with demand uncertainty which is very influential on the procurement of raw material supplies. So the holding of research with forecasting methods to calculate the needs in one production period. The variable in this research is about controlling raw material inventory. The first is to collect raw material needs data. Perform forecasting with the Exponential smoothing method α = 0.15, and Moving average N = 2. Next, the forecast results determine the smallest error value with indicators MAD, MSE, and MAPE. After the chosen method will be used as a reference for forecasting in the next period. Then perform efficient safety stock and reorder point calculations for one production period. From the results of calculations on the raw material yarn produces Maximum Inventory = 4287 kg; Safety Stock = 53 kg; Reorder Point = 128 kg while on the raw material paint Maximum Inventory = 304 kg; Safety Stock = 7 kg; Reorder Point = 12 kg.Industri Tenun Ikat Medali Mas sudah lama memproduksi kain tenun dalam berbagai model maupun corak. Permasalahan yang dihadapi oleh peneliti mengenai persediaan bahan baku, dikarenakan belum adanya pengendalian jumlah persediaan bahan baku yang dibutuhkan secara spesifik, sedangkan perusahaan dihadapkan pada ketidakpastian permintaan yang sangat berpengaruh pada pengadaan persediaan bahan baku. Sehingga diadakannya penelitian dengan metode forecasting untuk memperhitungkan kebutuhan dalam satu periode produksi. Variabel dalam penelitian ini tentang pengendalian persediaan bahan baku. Pertama dilakukan pengumpulan data kebutuhan bahn baku. Melakukan peramalan dengan metode Exponential smoothing α = 0,15, dan Moving average N = 2. Berikutnya dari hasil peramalan ditentukan nilai eror terkecil dengan indikator MAD, MSE, dan MAPE. Setelah metode terpilih nantinya akan dijadikan acuan untuk melakukan peramalan pada periode selanjutnya. Kemudian melakukan perhitungan safety stock dan reorder point yang efisien untuk satu periode produksi. Dari hasil perhitungan pada bahan baku benang menghasilkan Maximum Inventory = 4287 kg; Safety Stock = 53 kg; Reorder Point = 128 kg sedangkan pada bahan baku cat Maximum Inventory = 304 kg; Safety Stock = 7 kg; Reorder Point = 12 kg.
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Triplat Horvat, Martina, Ilija Grgić, and Dalibor Kušić. "Development of the Web-based State Border Geoinformation System of the Republic of Croatia (SBGiS)." Kartografija i geoinformacije 21 (January 3, 2023): 148–77. http://dx.doi.org/10.32909/kg.21.si.10.
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The development of the State Border Geoinformation System of the Republic of Croatia (SBGiS), based on open-source technologies, has facilitated and accelerated the storage, processing, handling, analysis and visualization of large amounts of spatial data used in open border issues, as well as standard affairs on maintaining the regulated state border of the Republic of Croatia. Centralized data storage and their spatial visualization through an interactive map allows citizens to see the situation at the state border in real time, which significantly increases the safety of movement in the border zone, but also aids in the prevention of state border breaches. The SBGiS is the only system that has been established not only for maintaining a regulated state border but also for resolving border disputes and delimitation procedures. At the end of the paper, a proposal for future system upgrades is given.
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Kokai-Kun, John F., J. Andrew Bristol, John Setser, and Michael Schlosser. "Nonclinical Safety Assessment of SYN-004." International Journal of Toxicology 35, no. 3 (December 23, 2015): 309–16. http://dx.doi.org/10.1177/1091581815623236.
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SYN-004 is a first in class, recombinant β-lactamase that degrades β-lactam antibiotics and has been formulated to be administered orally to patients receiving intravenous β-lactam antibiotics including cephalosporins. SYN-004 is intended to degrade unmetabolized antibiotics excreted into the intestines and thus has the potential to protect the gut microbiome from disruption by these antibiotics. Protection of the gut microbiome is expected to protect against opportunistic enteric infections such as Clostridium difficile infection as well as antibiotic-associated diarrhea. In order to demonstrate that oral SYN-004 is safe for human clinical trials, 2 Good Laboratory Practice-compliant toxicity studies were conducted in Beagle dogs. In both studies, SYN-004 was administered orally 3 times per day up to the maximum tolerated dose of the formulation. In the first study, doses of SYN-004 administered over 28 days were safe and well tolerated in dogs with the no-observed-adverse-effect level at the high dose of 57 mg/kg/day. Systemic absorption of SYN-004 was minimal and sporadic and showed no accumulation during the study. In the second study, doses up to 57 mg/kg/day were administered to dogs in combination with an intravenous dose of ceftriaxone (300 mg/kg) given once per day for 14 days. Coadministration of oral SYN-004 with intravenous ceftriaxone was safe and well tolerated, with SYN-004 having no noticeable effect on the plasma pharmacokinetics of ceftriaxone. These preclinical studies demonstrate that SYN-004 is well tolerated and, when coadministered with ceftriaxone, does not interfere with its systemic pharmacokinetics. These data supported advancing SYN-004 into human clinical trials.
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Oleson, F. B., C. L. Berman, J. B. Kirkpatrick, K. S. Regan, J. J. Lai, and F. P. Tally. "Once-Daily Dosing in Dogs Optimizes Daptomycin Safety." Antimicrobial Agents and Chemotherapy 44, no. 11 (November 1, 2000): 2948–53. http://dx.doi.org/10.1128/aac.44.11.2948-2953.2000.
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ABSTRACT Daptomycin is a novel lipopeptide antibiotic with potent bactericidal activity against most clinically important gram-positive bacteria, including resistant strains. Daptomycin has been shown to have an effect on skeletal muscle. To guide the clinical dosing regimen with the potential for the least effect on skeletal muscle, two studies were conducted with dogs to compare the effects of repeated intravenous administration every 24 h versus every 8 h for 20 days. The data suggest that skeletal-muscle effects were more closely related to the dosing interval than to either the maximum concentration of the drug in plasma or the area under the concentration-time curve. Both increases in serum creatine phosphokinase activity and the incidence of myopathy observed at 25 mg/kg of body weight every 8 h were greater than those observed at 75 mg/kg every 24 h despite the lower maximum concentration of drug in plasma. Similarly, the effects observed at 25 mg/kg every 8 h were greater than those observed at 75 mg/kg every 24 h at approximately the same area under the concentration-time curve from 0 to 24 h. Once-daily administration appeared to minimize the potential for daptomycin-related skeletal-muscle effects, possibly by allowing for more time between doses for repair of subclinical effects. Thus, these studies with dogs suggest that once-daily dosing of daptomycin in humans should have the potential to minimize skeletal-muscle effects. In fact, interim results of ongoing clinical trials, which have focused on once-daily dosing, appear to be consistent with this conclusion.
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Maxwell, Elizabeth A., Tamara I. King, Shyam H. Kamble, Kanumuri Siva Rama Raju, Erin C. Berthold, Francisco León, Bonnie A. Avery, Lance R. McMahon, Christopher R. McCurdy, and Abhisheak Sharma. "Pharmacokinetics and Safety of Mitragynine in Beagle Dogs." Planta Medica 86, no. 17 (July 21, 2020): 1278–85. http://dx.doi.org/10.1055/a-1212-5475.
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AbstractMitragynine is the most abundant psychoactive alkaloid derived from the leaves of Mitragyna speciosa (kratom), a tropical plant indigenous to regions of Southeast Asia. Mitragynine displays a moderate affinity to opioid receptors, and kratom is often self-prescribed to treat pain and/or opioid addiction. The purpose of this study was to investigate the safety and pharmacokinetic properties of mitragynine in the dog. Single dose oral (5 mg/kg) and intravenous (0.1 mg/kg) pharmacokinetic studies of mitragynine were performed in female beagle dogs. The plasma concentrations of mitragynine were measured using ultra-performance liquid chromatography coupled with a tandem mass spectrometer, and the pharmacokinetic properties were analyzed using non-compartmental analysis. Following intravenous administration, mitragynine showed a large volume of distribution (Vd, 6.3 ± 0.6 L/kg) and high clearance (Cl, 1.8 ± 0.4 L/h/kg). Following oral mitragynine dosing, first peak plasma (Cmax, 278.0 ± 47.4 ng/mL) concentrations were observed within 0.5 h. A potent mu-opioid receptor agonist and active metabolite of mitragynine, 7-hydroxymitragynine, was also observed with a Cmax of 31.5 ± 3.3 ng/mL and a Tmax of 1.7 ± 0.6 h in orally dosed dogs while its plasma concentrations were below the lower limit of quantification (1 ng/mL) for the intravenous study. The absolute oral bioavailability of mitragynine was 69.6%. Administration of mitragynine was well tolerated, although mild sedation and anxiolytic effects were observed. These results provide the first detailed pharmacokinetic information for mitragynine in a non-rodent species (the dog) and therefore also provide significant information for allometric scaling and dose predictions when designing clinical studies.
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Bednarz, Alexandra M., Emily N. Israel, Elizabeth J. Beckman, Michael Johansen, and Christopher A. Thomas. "Safety of enteral sildenafil in hemodynamically unstable children." Cardiology in the Young 29, no. 5 (May 2019): 589–93. http://dx.doi.org/10.1017/s1047951119000209.
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AbstractBackground:Enteral sildenafil may be used in the intensive care unit for treatment of pulmonary arterial hypertension. We aimed to determine if initial enteral sildenafil dosing is safe in children receiving concurrent vasoactive infusions.Methods:We performed a single-centre retrospective chart review that included patients less than 2 years of age in paediatric and cardiovascular intensive care units at an academic medical centre from 1 January, 2010 to 30 November, 2016. Included patients received concomitant enteral sildenafil and a continuously infused vasoactive agent. Exclusion criteria consisted of mechanical circulatory support, any form of dialysis, or a suspicion of septic shock at the time of sildenafil initiation. We sought to identify patients who developed worsening hemodynamic instability after initiation of enteral sildenafil defined as one or more of the following observations within 24 hours of sildenafil initiation: sildenafil discontinuation, total fluid bolus receipt >10 ml/kg, increased vasoactive support, epinephrine intravenous push administration, and/or the initiation of mechanical circulatory support.Results:Worsening hemodynamic instability was identified in 35% of the 130-patient cohort. Patients younger than 4 months were at increased risk of further hemodynamic instability compared with older patients (56% versus 44%, p = 0.0003) despite receiving lower median doses (1.28 mg/kg/day versus 1.78 mg/kg/day, p = 0.01).Conclusions:Critically ill children receiving vasoactive infusions may be at increased risk for further hemodynamic instability after initiation of enteral sildenafil, particularly in younger patients. This population may benefit from lower starting enteral sildenafil doses of 0.25 mg/kg/dose or less every 8 hours to avoid further hemodynamic compromise.
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Shin, Hyejeong, Yigun Lim, Jisu Ha, Gabsik Yang, and Taehan Yook. "The Evaluation of the Acute Toxicity and Safety of Verbenalin in ICR Mice." Journal of Acupuncture Research 39, no. 4 (November 30, 2022): 310–16. http://dx.doi.org/10.13045/jar.2022.00248.
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Background: Verbenalin is an iridoid glucoside, which is among the active components of some medicinal herbs such as Verbena officinalis Linn, and Cornus officinalis Siebold and Zucc. Previous studies have confirmed the antioxidant activity and neuroprotective potential of verbenalin. To confirm the safety of verbenalin, an approximate lethal dose was determined based on a single oral dose toxicity study.Methods: Institute of Cancer Research mice were randomly assigned to three verbenalin exposure groups (250, 500, and 1,000 mg/kg) and a control group (5% methylcellulose solution). There were (5 male and 5 female mice per group). Mortality, clinical signs, and body weight were monitored for 14 days, and necropsies were conducted.Results: No mortalities were observed in the control group or the verbenalin 250 mg/kg group, whereas mortalities were observed in the 500 mg/kg and 1,000 mg/kg verbenalin groups. During the observation period, stool abnormalities such as mucous stools were observed. Clinical signs such as loss of locomotor activity were observed in the 500 mg/kg and 1,000 mg/kg verbenalin groups. During the study period, significant changes in body weight were observed in the 500 mg/kg and 1,000 mg/kg verbenalin groups; however, no gross abnormalities were observed at necropsy. Overall, no toxicity was found in the 250 mg/kg group.Conclusion: The approximate lethal dose of verbenalin was estimated to be 500 mg/kg. For a more accurate assessment of the safety of verbenalin, other types of studies such as repeated-dose toxicity studies should also be conducted.
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Herzyk, Danuta J., Peter J. Bugelski, Timothy K. Hart, and Patrick J. Wier. "Preclinical Safety of Recombinant Human Interleukin-18." Toxicologic Pathology 31, no. 5 (August 2003): 554–61. http://dx.doi.org/10.1080/01926230390226681.
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Recombinant human interleukin-18 (rHuIL-18) is currently in clinical trials for treatment of cancer. This report presents results of preclinical toxicity studies with rHuIL-18 in cynomolgus monkeys and recombinant murine IL-18 (rMuIL-18) in mice. The rHuIL-18 was administered intravenously in 1 or 2 different 5-day cycles at doses 0.3 to 75 mg/kg/day in monkeys. Decreases in red cell mass, neutrophil, and platelet counts, increases in monocyte and large unstained cell counts, and lymphoid hyperplasia in spleen and lymph nodes were mild, reversible, and likely related to the pharmacologic activity of IL-18. The only toxic effect was protein cast nephropathy, secondary to coprecipitation of administered IL-18 and Tamm-Horsfall protein in the distal nephron, that only occurred at 75 mg/kg/day. Other adverse effects of rHuIL-18 were related to strong immunogenicity in monkeys and were manifest only during a second dosing cycle. The rMuIL-18, at similar dosing levels and cycles in mice, resulted in reduced red cell mass, increased white blood cell counts, spleen and lymph node hyperplasia, and mild, reversible changes in intestine, liver, and lungs. Protein cast nephropathy occurred in mice at doses ≥30 mg/kg/day. In conclusion, preclinical safety studies showed that rIL-18 was well tolerated at pharmacologically active doses in both monkeys and mice.
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Lestari, Fatma, and Budi Hartono. "Peningkatan Pengetahuan dan Keterampilan Masyarakat tentang Cara Aman Menggunakan Tabung Gas 3 Kg." Kesmas: National Public Health Journal 6, no. 5 (April 1, 2012): 225. http://dx.doi.org/10.21109/kesmas.v6i5.88.
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Konversi penggunaan minyak tanah ke tabung liquified petroleum gas (LPG) merupakan kebijakan yang bertujuan untuk mengurangi subsidi bahan bakar minyak. Namun, program ini menuai beberapa permasalahan dari aspek keselamatan seperti terjadi kebakaran, ledakan yang mengaki- batkan jatuhnya korban jiwa, luka-luka, ataupun kerugian material. Statistik menunjukkan kejadian ledakan dan kebakaran tabung LPG 3 kg pada pengguna cukup tinggi antara tahun 2010 – 2011. Penelitian ini bertujuan untuk mengetahui peningkatan pengetahuan dan keterampilan masyarakat pengguna LPG 3 kg tentang cara aman menggunakan tabung LPG 3 kg setelah dilakukan program intervensi melalui penyuluhan dan pelatihan. Lokasi penelitian ini dilakukan di Kelurahan Tirtajaya, Depok. Hasil penelitian ini menunjukkan bahwa setelah program intervensi melalui kegiatan penyuluhan dan pelatihan terjadi peningkatan pengetahuan dan keterampilan tentang cara aman menggunakan tabung LPG 3 kg dan aksesorisnya.Kata kunci: Tabung gas 3 kg, kebakaran, ledakan, keselamatanAbstractGovernment program towards the conversion from kerosene uses to liquified petroleum gas (LPG) has generated a safety problems such as fire, explosion that effect death, injury, or material losses. There has been many fire and explosion accidents related to the use of 3 kg LPG container in the public and statistically high number of accidents occur in the year of 2010 – 2011. The objectives of the research is to investigate the improvement of knowledge and skills in the public related to safe use of 3 kg LPG container and its accessories after the intervention program through training and counseling. Research was conducted at Kelurahan Tirtajaya, Depok. Research suggested that after the intervention towards training and counseling there has been improvement on the knowledge and skill towards the safe use of LPG 3 kg and its accessories.Key words: 3 kg LPG container, fire, explosion, safety
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Arai, Satoshi, Jun-ichi Minami, Masamichi Muto, Noriyuki Iwabuchi, Koji Yamauchi, Jin-zhong Xiao, and Fumiaki Abe. "Safety evaluation of Bifidobacterium breve MCC1274 via oral toxicity tests in rats." Toxicology Research and Application 2 (January 1, 2018): 239784731880737. http://dx.doi.org/10.1177/2397847318807373.
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In this study, the safety of Bifidobacterium breve MCC1274, a probiotic bifidobacterial strain, was assessed by single-dose and 90-day repeated-dose oral toxicity studies. In the single-dose oral toxicity assay using 6000 mg/kg of B. breve MCC1274 corresponding to 8.4 × 1011 colony-forming unit (CFU)/kg, mortality and adverse effects were not observed. Furthermore, the administration of 1000 mg/kg of B. breve MCC1274 by oral gavage in saline for 90 days did not induce any signs of toxicity, such as changes in clinical signs, body weight (BW), food consumption, ophthalmoscopy, urinalysis, hematology, blood chemistry, organ weight, gross pathology, and histopathology compared to the control group given cornstarch in saline (10/sex/group). The no-observed-adverse-effect-level of B. breve MCC1274 in the 90-day repeated-dose toxicity study was greater than 1000 mg/kg corresponding to 1.3 × 1011 CFU/kg. Based on the findings of this study, the acceptable daily intake of B. breve MCC1274 was calculated to be 1.3 × 109 CFU/kg BW/day.
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Rapa, Mattia, Salvatore Ciano, Laura Gobbi, Roberto Ruggieri, and Giuliana Vinci. "Quality and safety evaluation of new tomato cultivars." Italian Journal of Food Science 33, no. 2 (April 7, 2021): 35–45. http://dx.doi.org/10.15586/ijfs.v33i2.1921.
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Tomato (Solanum lycopersicum) is a dietary source of bioactive compounds and breeding programs continuously create new cultivars with different nutritional and organoleptic characteristics. The aim of this work is to provide a quality and safety assessment of new tomato cultivars: Bamano, Dulcemiel and Sugarland. Eight biogenic amines, total phenolic content and antioxidant activity (DPPH and ABTS assays) have been determined. Tyramine was not detected in any samples. Sugarland was characterized by a high content of serotonin (266.87 ± 11.16 mg/kg) and phenolic compounds (303.15 ± 21.62 mgGAE/kg). Moreover, multivariate statistical analyses were applied to the data matrix.