• Title/Summary/Keyword: Safety pharmacology

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Cigarette Alternatives: Are they Safe?

  • Shantakumari, Nisha;Muttappallymyalil, Jayakumary;John, Lisha Jenny;Sreedharan, Jayadevan
    • Asian Pacific Journal of Cancer Prevention
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    • v.16 no.8
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    • pp.3587-3590
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    • 2015
  • In spite of limited data regarding the safety or effectiveness of electronic cigarette introduced into the market as a healthier alternative to tobacco smoking, its popularity has increased enormously. E-cigarettes have penetrated the market rapidly owing to the elaborate marketing network and attractive marketing strategies. Stated advantages include the claim that they help quit smoking and produce less exposure than conventional smoking. The list of disadvantages is even more elaborate. While the majority of the studies supporting health claims and efficacy for quitting smoking are not scientifically sound, they are also challenged by studies providing contradictory results. Owing to the limited evidence on the potential advantages and disadvantages of e-cigarettes, the debate on their safety continues.

Review of cases of patient risk associated with ginseng abuse and misuse

  • Paik, Doo Jin;Lee, Chang Ho
    • Journal of Ginseng Research
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    • v.39 no.2
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    • pp.89-93
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    • 2015
  • Ginseng has long been used as a functional food or therapeutic supplement and it is empirically known to be safe and nontoxic. During recent decades, a number of in vitro and in vivo experiments, as well as human studies have been conducted to prove the safety of various types of ginseng samples and their components. Clinical trials, case reports, and in vitro and in vivo research articles addressing the safety, toxicity, and other adverse events of ginseng application were selected and reviewed. Patient risks associated with ginseng abuse and misuse such as affective disorder, allergy, cardiovascular and renal toxicity, genital organ bleeding, gynecomastia, hepatotoxicity, hypertension, reproductive toxicity, and anticoagulant-ginseng interaction were reviewed and summarized. There are some cases of patient risk associated with ginseng abuse and misuse depending on patients' conditions although further investigation in more cases is required to clarify these issues.

Long-term measurement of physiological cardiovascular parameters using telemetry system in dosgs.

  • Kim, Eun-Joo;Seo, Joung-Wook;Choi, Gyu-Kap;Park, Eun-Kyung;Kim, Ki-Suk;Shin, Won-Ho;Han, Sang-Seop
    • Proceedings of the PSK Conference
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    • 2003.10b
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    • pp.87.1-87.1
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    • 2003
  • With the issuance of the ICH “Guidance for industry S7A Safety Pharmacology Studies For Human Pharmaceuticals” in July 2001 came the preference for the use of unanesthetized animals when evaluation the safety profile of new pharmaceutical agents. Telemetry provides a means of obtaining measurements of physiological functions in conscious animals without the problems associated with classical cardiovascular measuring methods. The Korea Institute of Toxicology (KIT) established the telemetric measurement of cardiovascular parameters, such as Blood pressure, Heart rate, ECG (PR, RR, QRS, QT and QTcB interval) under GLP conditions. (omitted)

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Safety pharmacology study of AS2-006A, a new wound healing drug

  • Kim, Hyun-Jin;Choi, Kyu-Gap;Yoon, Mi-Ran;Do, Sun-Hee;Kim, Eun-Joo;Cha, Kyung-Hoi
    • Proceedings of the PSK Conference
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    • 2002.10a
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    • pp.287.2-287.2
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    • 2002
  • The safety pharmacological core battery studies of AS2-006A. a newly developed wound healing drug, were investigated according to the ICH S7A guidelines in compliance with Good Laboratory Practice(GLP) Regulations, The doses given were 0, 100. 300 and 1000 mg/kg and drugs were administered subcutaneously. The animals used for this study were mice, rats and guinea pigs. AS2-006A showed no effects on the central nervous system such as motor activity. behaviotal changes. coordination, sensory/motor reflex responses and body temperature. no effects on blood pressure(BP). heart rate(HR), and ECG profiles and respiratory system. it was concluded that AS2-006A possess no general pharmacological effects at all doses tested. (omitted)

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Synthetic Cannabinoid-Induced Immunosuppression Augments Cerebellar Dysfunction in Tetanus-Toxin Treated Mice

  • Yun, Jaesuk;Gu, Sun Mi;Lee, Tac-hyung;Song, Yun Jeong;Seong, Seonhwa;Kim, Young-Hoon;Cha, Hye Jin;Han, Kyoung Moon;Shin, Jisoon;Oh, Hokyung;Jung, Kikyung;Ahn, Chiyoung;Park, Hye-Kyung;Kim, Hyung Soo
    • Biomolecules & Therapeutics
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    • v.25 no.3
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    • pp.266-271
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    • 2017
  • Synthetic cannabinoids are one of most abused new psychoactive substances. The recreational use of abused drug has aroused serious concerns about the consequences of these drugs on infection. However, the effects of synthetic cannabinoid on resistance to tetanus toxin are not fully understood yet. In the present study, we aimed to determine if the administration of synthetic cannabinoids increase the susceptibility to tetanus toxin-induced motor behavioral deficit and functional changes in cerebellar neurons in mice. Furthermore, we measured T lymphocytes marker levels, such as CD8 and CD4 which against tetanus toxin. JWH-210 administration decreased expression levels of T cell activators including cluster of differentiation (CD) $3{\varepsilon}$, $CD3{\gamma}$, CD74p31, and CD74p41. In addition, we demonstrated that JWH-210 induced motor impairment and decrement of vesicle-associated membrane proteins 2 levels in the cerebellum of mice treated with tetanus toxin. Furthermore, cerebellar glutamatergic neuronal homeostasis was hampered by JWH-210 administration, as evidenced by increased glutamate concentration levels in the cerebellum. These results suggest that JWH-210 may increase the vulnerability to tetanus toxin via the regulation of immune function.

Pharmacological and Toxicological review of Yukmijihwang-tang(Hwan) (육미지황탕(환)의 약리와 독성에 대한 문헌고찰)

  • Park, Yeong-Chul;Kim, Jong-Bong;Kook, Yoon-Boom;Lee, Sun-Dong
    • Herbal Formula Science
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    • v.20 no.1
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    • pp.13-24
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    • 2012
  • Objectives : Yukmijihwang-tang(Wan), a well-known formula for invigorating yin-particular kidney yin, was first recorded in "Xiao er Yao Zheng Zhi Jue", consisting of Radix Rehmanniae Preparata, Fructus Macrocarpii, Rhizoma Dioscoreae Oppositae, Poria, Rhizoma Alismatis and Cortex Moutan Radicis with dose proportion of 8:4:4:3:3:3. Although clinical trials have been lacking, various pharmacological actions for Yukmijihwang-tang has been identified newly using animal models. In addition, it was reported that Yukmijihwang-tang increases structural chromosome aberrations significantly in Chinese hamster lung cells. In this article, it is purposed that new studies for pharmacology and toxicology of Yukmijihwang-tang are reviewed. Insight into new studies of Yukmijihwang-tang at the cellular and animal levels will enhance our understanding of Yukmijihwang-tang against various diseases will provide new tools to diagnose and treat patients. Methods : Recent researches for Yukmijihwang-tang were reviewed and summarized in terms of pharmacological action and toxicity. All sources for review were based on recent studies loaded on data base of web sites such as Science Direct and National Center for Biotechnology Information. Results and Conclusions : Recently, reports showed that YMJ had antiaging effects, antioxidant and free radical scavenging activities, anti-renal hypertension and prevented tumors, and diabetes mellitus. However, there is little information on its safety except general toxicity, acute and sub-chronic oral toxicity, or genotoxicity. In addition, clinical trial for Yukmijihwang-tang was limited even though Yukmijihwang-tang has been used extensively in Korean traditional medicine. Thus, further studies are necessary to focus on safety evaluation and clinical trial for Yukmijihwang-tang.

Primers for Typing Salmonella spp. using Random Amplified Polymorphic DNA (RAPD) Analysis (Salmonella spp.의 RAPD Typing을 위한 Primer의 분리력 비교)

  • Lim, Hyung-Kum;Lee, Kyung-Hee;Hong, Chong-Hae;Park, Gyung-Jin;Choi, Weon-Sang
    • Journal of Food Hygiene and Safety
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    • v.18 no.4
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    • pp.224-228
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    • 2003
  • Random amplified polymorphic DNA (RAPD) analysis is based on the amplification of random DNA segment using a single arbitratrary primer. For typing Salmonella spp., polymorphic DNA patterns identified by this method can be used. To select the primers for RAPD typing Salmonella spp., the performances of 20 primers were compared by analyzing 16 Salmonella spp. reference strains. Reproducible electrophoresis patterns were obtained. Among the 20 primers tested, 4 primers (A, OPG04, OPG10, OPL03) showed better differentiation than the others. At the time discrimination index, band clarity, band number and difficulty of band scoring were considered. These primers will be useful for typing Salmonella spp. in the future. Curretly, we are under investigation for the RAPD typing of contaminated Slmonella spp. for the risk analysis of pork processing plant using the primers.

A brief survey on awareness of pharmacovigilance among ayurveda physicians in Sri Lanka

  • Perera, Pathirage Kamal;Dahanayake, Jeevani;Karunagoda, Kaumadi
    • CELLMED
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    • v.5 no.1
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    • pp.3.1-3.3
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    • 2015
  • Pharmacovigilance is the study of the safety of drugs under the practical conditions of clinical usage in large communities. Aim of this study was to assess the pharmacovigilance awareness among a focus group of Ayurveda physicians in Sri Lanka who participated for their postgraduate studies. A questionnaire which was suitable for assessing the basic knowledge, attitude and the practice of pharmacovigilance was designed and submitted among group of Ayurveda physicians (n = 30) who participated for postgraduate studies in Institute of Indigenous Medicine, University of Colombo, Sri Lanka. Among participants30% of the subjects knew the term pharmacovigilance, 20% were aware of the unavailability of the National Pharmacovigilance Program for Ayurveda and Traditional Medicine in Sri Lanka, 70% believe about Adverse Drug Reactions (ADRs) may be occurred from Ayurveda medicine, 60% indicated that Most labeled counterfeit drugs, inappropriate use and standardization problems as the most important causes of ADRs associated with Ayurvedicdrugs, 70% physicians accepted their ignorance about pharmacovigilance and admitted that there was a need for better training of this subject and 90% admitted that there should be a national pharmacovigilance programme for Ayurveda medicines in Sri Lanka. We strongly suggest that there is an urgent need for a regular training and the introduce ADRs reporting system among the Ayurveda physicians. Also systematic pharmacovigilance programme is essential to build up for reliable information on the safety and effective practice of Ayurveda medicine in Sri Lanka.

Evaluation of Safety with Gamgung-tang Using Ames and umu Assays (Ames 및 umu assay를 이용한 감궁탕의 안전성평가)

  • Shon Yun Hee;Kim Cheorl Ho;Nam Kyung Soo
    • Journal of Life Science
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    • v.15 no.2 s.69
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    • pp.215-219
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    • 2005
  • Gamgung-tang (GGT) that is included in Gamdu-tang (consists of Glycyrrhizae Radix, black beans) and Gunggui-tang(consists of Angelicae Radix and Cnidii Rhizoma) showed therapeutic effect of autoimmume thyroiditis in the previous reports. GGT was tested for the safety using Ames and umu gene expression mutagenicity tests. In Ames test, Salmonella typhimurium TA98 and TA100 were used to identify mutagenic property, and the number of histidine revertants was measured. In SOS umu test, Salmonella typhimurium TA1535 containing plasmid pSK1002 was used as a test strain, and we monitored the levels of umu operon expression by measuring the $\beta-galactosidase$ activity. Mutagenic activity in any assays we tested was not found. After treating S-9 mixture with GGT, mutagenic activity was also not found. The results of this study suggested that there was no DNA damage and mutagenicity of GGT.

General Pharmacology of DA-8159, a New Pyrazolopyrimidinone Derivative (새로운 피라졸로피리미디논 유도체 DA-8159의 일반약리작용)

  • 오태영;김동환;손문호;김동성;안병옥;김순회;김원배
    • Biomolecules & Therapeutics
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    • v.11 no.1
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    • pp.41-50
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    • 2003
  • General pharmacological properties of DA-8159, a new pyrazolopyrimidinone derivative were examined in laboratory animals to investigate its safety profile. The oral administration of DA-8159 (1, 5 or 30 mg/kg) in mice and rats had no effect on general behaviors and central nervous system of the animals in test systems, such as hexobarbital-induced sleeping time, motor coordination, normal body temperature, writhing syndromes induced by 0.75% acetic acid solution, chemo-shock produced by pentetrazole solution and rotar rod test. Anesthetized cats treated intravenously with DA-8159 (0.1, 0.3, 1, 3 or 10 mg/kg) showed transient and mild decrease in blood pressure. However, heart rate, respiration rate and tidal volume were not changed by intravenous DA-8159. In the isolated organs including ileum, heart (sinus rate of atria and contractility of papillary muscle), trachea of guinea pigs and phrenic nerve of rats, DA-8159 ($10^{-8}$$10^{-5}$ mg/L) did not elicit any effect or inhibitory action on the chemically or electrically stimulated contraction. DA-8159 did not influence gastric secretion, pH and total acid output in rats and intestinal propulsion in mice. The administration of DA-8159 in rats had no effect on the platelet aggregation induced by ADP in rabbit plasma, urinary volume and electrolyte ion ($Na^{+}$, $K^{+}$, $Cl^{-}$) excretion in rats. Prothrombin time (PT) of the rats showed a mild but significant increase after administration of DA-8159. Activated partial thromboplastin time (APTT), however, was not affected by DA-8159. These results indicate that DA-8159 does not exert any of serious pharmacological effects.