• 제목/요약/키워드: safety evaluation

검색결과 7,542건 처리시간 0.039초

Dependence Potential of Quetiapine: Behavioral Pharmacology in Rodents

  • Cha, Hye Jin;Lee, Hyun-A;Ahn, Joon-Ik;Jeon, Seol-Hee;Kim, Eun Jung;Jeong, Ho-Sang
    • Biomolecules & Therapeutics
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    • 제21권4호
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    • pp.307-312
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    • 2013
  • Quetiapine is an atypical or second-generation antipsychotic agent and has been a subject of a series of case report and suggested to have the potential for misuse or abuse. However, it is not a controlled substance and is not generally considered addictive. In this study, we examined quetiapine's dependence potential and abuse liability through animal behavioral tests using rodents to study the mechanism of quetiapine. Molecular biology techniques were also used to find out the action mechanisms of the drug. In the animal behavioral tests, quetiapine did not show any positive effect on the experimental animals in the climbing, jumping, and conditioned place preference tests. However, in the head twitch and self-administration tests, the experimental animals showed significant positive responses. In addition, the action mechanism of quetiapine was found being related to dopamine and serotonin release. These results demonstrate that quetiapine affects the neurological systems related to abuse liability and has the potential to lead psychological dependence, as well.

Rapid determination and quantification of hair-growth compounds in adulterated products by ultra HPLC coupled to quadrupole-orbitrap MS

  • Lee, Ji Hyun;Park, Han Na;Kang, Gihaeng;Kim, Nam Sook;Park, Seongsoo;Lee, Jongkook;Kang, Hoil
    • 분석과학
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    • 제32권2호
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    • pp.56-64
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    • 2019
  • Recently, a number of adulterated products, which are advertised as hair-growth enhancer have been emerged among those who suffer hair loss disease. For continuous control of illegal products, in this study, a rapid and sensitive method for simultaneous screening of 12 compounds that enhance hair-growth was established to protect public health by ultrahigh-performance liquid chromatography coupled to quadrupole-orbitrap mass spectrometry (UHPLC-Q-Orbitrap-MS). Fragmentation pathways of them were proposed based on $MS^2$ spectral data obtained using the established method. In this analysis, the LODs and LOQs ranged from 0.05 to 50 ng/mL and from 0.17 to 167 ng/mL, respectively. The square of the linear correlation coefficient ($R^2$) was determined as more than 0.995. The intra- and inter-assay accuracies were respective 88-112 % and 88-115 %. Their precision values were measured within 5 % (intra-day) and 10 % (inter-day). Mean recoveries of target compounds in adulterated products ranged from 84 to 115%. The relative standard deviation of stability was less than 12 % at $4^{\circ}C$ for 48 h. The method was employed to screen 14 dietary supplements advertised to be effective for the treatment of hair loss. Some of the products (~21 %) were proven to contain synthetic drugs that promote hair growth such as triaminodil, minoxidil, and finasteride.

조사선원에 따른 향신료의 PSL과 TL 검지 특성 (Detection Characteristics of PSL and TL Methods in Spices Irradiated with Different Radiation Sources)

  • 김규헌;곽지영;김정기;황초롱;이재황;박용춘;김재이;조태용;이화정;이상재;한상배
    • 방사선산업학회지
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    • 제7권1호
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    • pp.15-21
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    • 2013
  • The detection characteristics of irradiated spices were investigated depending on radiation sources and doses by photostimulated luminescence (PSL) and Thermoluminescence (TL). 6 kinds of spices (turmeric, onion powder, red pepper, basil, parsley, black pepper) were irradiated at 0 to 10 kGy under ambient conditions by both a $^{60}Co$ gamma irradiator and an electron beam (EB) accelerator, respectively. The PSL analysis showed negative results for non-irradiated spices, while irradiated spices gave intermediate and positive value, which presented the limited potential of PSL technique. In TL measurement, TL glow curves on non-irradiated samples appeared at about $300^{\circ}C$ with low intensity. All irradiated samples were easily distinguishable through radiation-specific strong TL glow curves with maximum peak in range of $150{\sim}200^{\circ}C$. TL ratio ($TL_1/TL_2$) obtained by a re-irradiation step could verify the detection result of $TL_1$ glow curves, showing ratios lower than 0.1 in the non-irradiated sample and higher than 0.1 in irradiated ones. Therefore, in PSL measurement, the identification of irradiated spices showed more clear results in electron beam irradiated samples. TL analysis showed obvious difference between non-irradiated and irradiated samples in gamma ray and electron beam irradiated samples.

교육시설의 사용자 중심 화재안전수준 평가모형 개발 (Development of User-centered Fire Safety Evaluation Model for School Buildings)

  • 박성철;김진욱
    • 한국건축시공학회:학술대회논문집
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    • 한국건축시공학회 2021년도 가을 학술논문 발표대회
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    • pp.238-239
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    • 2021
  • This study presented the development of a user centered school facility fire safety evaluation model that would support fire safety evaluation, which is globally recognized as being important in terms of school safety, to be more efficiently implemented in the school field mainly by students. The study consisted of five steps. First, actual condition survey tools were developed based on the major fire safety evaluation items derived through literature review. Second, the characteristics of domestic school facilities in terms of fire safety were developed using the survey tools. Third, an evaluation model at a level utilizable by students was developed based on the foregoing characteristics. Fourth, the applicability of the model was verified through a trial application of the model to elementary school students. Finally, legal and institutional improvement plans and fire safety education materials were presented through a policy proposal.

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산업장 안전보건교육 프로그램 평가지표 개발 (Development of Evaluation Indicator on Industrial Safety and Health Education Program)

  • 오영아;이명선
    • 보건교육건강증진학회지
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    • 제24권4호
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    • pp.41-64
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    • 2007
  • Objectives: The purpose of this study was to verify the validity of the evaluation indicators on safety and health education programs provided to Korean industrial workers, by developing further. Methods: To develop the early evaluation indicator, the secondary analysis was made on 'Survey on Industrial safety & health trends', the national wide survey data product by Korea Occupational Safety & Health Agency, as well as the various examinations on literatures. To validate such developed evaluation indicator, 13 safety and health managers in Focus Group discussion to prove the reliability of the contents were composed. To confirm the face validity, the interview with 6 industrial safety and health education experts was held to study the appropriateness of the content. With the cooperation from Korea Occupational Safety & Health Agency, the structured survey was performed with the safety and health managers from 588 businesses who participated in the education program for the later half of 2006. In this study, the number of responses was randomly divided into 1:1 two groups, in which one group was for the Exploratory Factor Analysis and the other group was for the Confirmatory Factor Analysis. Results: The results were as follows. First, for the Structure category, 18 evaluation indicators were developed into 4 evaluation categories such as a preliminary examination, education staff and organization, education environment and rules/ regulation. Secondly, the Activity category was comprised of 10 evaluation indicators with respect to 2 areas of curriculum satisfaction and program evaluation. Finally, for the Output category, 9 evaluation indicators were developed into 2 evaluation areas such as documentation and information share and education effects. Conclusions: The evaluation indicators developed through this study will possibly develop and be applied to evaluation tools on safety and health education program, which may further become the standardized indicators to better operate the industrial safety and health education programs.

Cardiovascular Safety Pharmacology of Sibutramine

  • Yun, Jaesuk;Chung, Eunyong;Choi, Ki Hwan;Cho, Dae Hyun;Song, Yun Jeong;Han, Kyoung Moon;Cha, Hey Jin;Shin, Ji Soon;Seong, Won-Keun;Kim, Young-Hoon;Kim, Hyung Soo
    • Biomolecules & Therapeutics
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    • 제23권4호
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    • pp.386-389
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    • 2015
  • Sibutramine is an anorectic that has been banned since 2010 due to cardiovascular safety issues. However, counterfeit drugs or slimming products that include sibutramine are still available in the market. It has been reported that illegal sibutramine-contained pharmaceutical products induce cardiovascular crisis. However, the mechanism underlying sibutramine-induced cardiovascular adverse effect has not been fully evaluated yet. In this study, we performed cardiovascular safety pharmacology studies of sibutramine systemically using by hERG channel inhibition, action potential duration, and telemetry assays. Sibutramine inhibited hERG channel current of HEK293 cells with an $IC_{50}$ of $3.92{\mu}M$ in patch clamp assay and increased the heart rate and blood pressure ($76{\Delta}bpm$ in heart rate and $51{\Delta}mmHg$ in blood pressure) in beagle dogs at a dose of 30 mg/kg (per oral), while it shortened action potential duration (at $10{\mu}M$ and $30{\mu}M$, resulted in 15% and 29% decreases in $APD_{50}$, and 9% and 17% decreases in $APD_{90}$, respectively) in the Purkinje fibers of rabbits and had no effects on the QTc interval in beagle dogs. These results suggest that sibutramine has a considerable adverse effect on the cardiovascular system and may contribute to accurate drug safety regulation.

서방성 제제의 생물학적동등성시험을 위한 가이드라인 (Guideline for Bioequivalence Studies of Controlled Release Products)

  • 서현옥;김소희;안미령;안충열;박혜진;오은경;이은주;김보연;김민정;우나리;서희원;정수연
    • Journal of Pharmaceutical Investigation
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    • 제40권1호
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    • pp.63-66
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    • 2010
  • The "Guidance Document for Bioequivalence Study" was revised for adding to bioequivalence studies of controlled-release products after meal(Korea Food & Drug Administration Notification #2008-22, 2008.5.7). The bioequivalence study design for controlled-release products is $2{\times}2$ crossover under fast and fed condition in respect. For studies of controlled-release products under fed study, the same high-fat diet should be taken within 20 minutes in at least a 10-hour fasting state. The drug products should be administered 30 minutes after the meal started. A high-fat(more than 35 percent of total caloric content of the meal) and high-calorie(over 900 calories) meal is recommended as a test meal for fed BE studies.

헛개나무과병추출물 중 퀘르세틴 분석 (Analysis of quercetin in extract of Hovenia dulcis Thunb)

  • 허수정;오재명;오현숙;문명희;배윤영;이성혜;김지안;구용의
    • 분석과학
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    • 제29권6호
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    • pp.255-260
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    • 2016
  • "건강기능식품에 관한 법률"에 따라 건강기능식품이란 인체에 유용한 기능성을 가진 원료나 성분을 사용하여 제조한 식품을 말한다. 또한, 건강기능식품은 고시화한 원료와 영업자가 개별적으로 신청한 개별인정형 원료로 나누어진다. 그 중 개별인정형 원료의 시험법은 고시화를 위해 표준화가 필요하며 2가지 이상의 원료가 복합적으로 혼합되어 제조될 경우 제품에 대한 적용성 검토가 요구된다. 개별인 정형 원료 중 헛개나무과병추출물의 지표성분인 퀘르세틴을 대상으로 전처리방법을 표준화하였으며, 표준화한 퀘르세틴 시험법의 밸리데이션을 수행한 결과 회수율은 97.1~105.4%, 표준편차는 1.15~3.11%였다. 검량선의 직선성은 결정계수($R^2$)가 0.999 이상을 나타냈고 검출한계는 $0.12{\mu}g/mL$, 정량한계는 $0.36{\mu}g/mL$를 나타냈다. 표준화한 퀘르세틴 시험법의 적용성 검토를 위해 헛개나무과병추출물의 유통제품을 수거하여 분석한 결과, 퀘르세틴 표시 함량 대비 82.5~105.1%로 적합하였다.

Phototoxicity Evaluation of Pharmaceutical Substances with a Reactive Oxygen Species Assay Using Ultraviolet A

  • Lee, Yong Sun;Yi, Jung-Sun;Lim, Hye Rim;Kim, Tae Sung;Ahn, Il Young;Ko, Kyungyuk;Kim, JooHwan;Park, Hye-Kyung;Sohn, Soo Jung;Lee, Jong Kwon
    • Toxicological Research
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    • 제33권1호
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    • pp.43-48
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    • 2017
  • With ultraviolet and visible light exposure, some pharmaceutical substances applied systemically or topically may cause phototoxic skin irritation. The major factor in phototoxicity is the generation of reactive oxygen species (ROS) such as singlet oxygen and superoxide anion that cause oxidative damage to DNA, lipids and proteins. Thus, measuring the generation of ROS can predict the phototoxic potential of a given substance indirectly. For this reason, a standard ROS assay (ROS assay) was developed and validated and provides an alternative method for phototoxicity evaluation. However, negative substances are over-predicted by the assay. Except for ultraviolet A (UVA), other UV ranges are not a major factor in causing phototoxicity and may lead to incorrect labeling of some non-phototoxic substances as being phototoxic in the ROS assay when using a solar simulator. A UVA stimulator is also widely used to evaluate phototoxicity in various test substances. Consequently, we identified the applicability of a UVA simulator to the ROS assay for photoreactivity. In this study, we tested 60 pharmaceutical substances including 50 phototoxins and 10 non-phototoxins to predict their phototoxic potential via the ROS assay with a UVA simulator. Following the ROS protocol, all test substances were dissolved in dimethyl sulfoxide or sodium phosphate buffer. The final concentration of the test solutions in the reaction mixture was 20 to $200{\mu}M$. The exposure was with $2.0{\sim}2.2mW/cm^2$ irradiance and optimization for a relevant dose of UVA was performed. The generation of ROS was compared before and after UVA exposure and was measured by a microplate spectrophotometer. Sensitivity and specificity values were 85.7% and 100.0% respectively, and the accuracy was 88.1%. From this analysis, the ROS assay with a UVA simulator is suitable for testing the photoreactivity and estimating the phototoxic potential of various test pharmaceutical substances.

Stability Evaluation of National Reference Standards for Blood Products in Korea

  • Park, Tae Jun;Choi, Chan Woong;Oh, Ho Kyung;Kim, Jae Ok;Kim, Byung Kuk;Kang, Hyun Kyung;Kwon, Eun Jeong;Gweon, Eun Jeong;Park, Sang Jin;Kang, Ho Il;Jung, Ki Kyung;Park, Sang Mi;Kim, Ji Hye;Han, Ki Won;Jeong, Ja Young
    • Toxicological Research
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    • 제33권3호
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    • pp.225-231
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    • 2017
  • National reference standards (NRSs) for biologics are established through potency estimation by a multi-center joint study of standard materials used in the approval process for national lot release and quality control of vaccines, blood products, and other biologics. In this study, a stability evaluation was conducted to determine whether the potency of NRSs for six blood products was being maintained at a consistent level in Korea. The present study conducted real-time stability tests via in-vivo/in-vitro bioassay on NRSs for blood coagulation factor VIII concentrate (2nd standard), antithrombin concentrate, prekallikrein activator, anti-hepatitis B immunoglobulin, blood coagulation factor IX concentrate, and anti-tetanus human immunoglobulin, as well as a trend analysis using cumulative annual results. The real-time stability test results showed that the mean potency of six NRSs was all within the control limit. In the trend analysis, the potency of NRS for blood coagulation factor VIII concentrate (2nd standard) showed a decreasing trend, while the potency of all other products had been stably maintained. The present study confirmed that the mean potency of NRSs for six blood products had been stably maintained in Korea. The findings of the present study establish a foundation that can ensure the quality of NRSs for biologics in Korea, and it is expected to make a major contribution to the supply of high-quality biologics.