• Toxicological Research
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• 제23권2호
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• pp.173-177
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• 2007

The GLP contains specific language concerning characterization of the test, control and reference substances used in toxicity studies. This paper will describe and discuss what types of documents are required to support test/reference substance characterization under GLP system. The purpose of this article is to present an overview of data needed in the characterization package that will adequately define the substance. Most sponsors use a certificate of analysis (COA) to communicate the test sub-stance characterization status information to the contracting research organizations. The COA should provide the test $material^{\circ}{\phi}s$ characterization results, substance storage requirements, expiration dates, verification of the collection of the retention sample, archival location of the data to support the characterization and GLP compliance status of the characterization.

• 한국사회복지학
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• 제48권
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• pp.243-270
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• 2002

The purpose of this study was to test the effectiveness of cognitive-behavioral therapy to prevent relapse of substance abuse. A total of 8 substance abusing adult clients participated in the program. All the clients were charged with substance use at the time of implementing the program. Two master's level social workers operated the program, which was implemented in a probation office in Seoul. This study included Beliefs about substance use, abstinence self-efficacy, and coping skills as dependent variables in order to investigate the effectiveness. Cognitive-behavioral therapy emphasizes the enhancement of these cognitive and behavioral skills to prevent relapse of substance use. Research hypotheses were partially supported. That is, clients participated in the program had more negative attitude toward substance use and had more effective problem-focused coping skills. Although a research hypothesis of the enhancement of clients' self efficacy was not supported, their mean scores at the final post test were lower than scores at pretest. This study suggests that more studies be needed to in order to confirm the effectiveness of cognitive-behavioral therapy with substance abusing clients.

• Journal of Dairy Science and Biotechnology
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• 제34권2호
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• pp.99-116
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• 2016

본 시험은 sialic acid가 7%를 함유하도록 제조한 유청가수분해단백분말제제(whey protein of hydrolysis)의 기능성 식품원료로 개발을 위한 동물안전성을 평가함에 연구목표를 두었다. GMP를 원료로 제조한 시험물질은 sialic acid 7%(v/v)와 원료인 GMP 가수분해 단백질이 93%로 구성되어 있었다(시험명: 7%-GNANA). 시험물질의 독성 유무는 한국식품의약안전청(KFDA, 2014)과 OECD(2008)의 의약품 등의 독성시험 기준에 따라 실시하였다. 평가방법으로서, 시험물질의 투여용량을 0, 1,250, 2,500 및 5,000 mg/kg/day로 하여 SPF Sprague-Dawley 계열 암수 랫드에 90일 동안 반복경구투여하였을 때 나타나는 독성 여부를 평가하였다. 평가항목으로서는 사망률, 일반증상관찰, 체중 변화, 사료 섭취량 측정, 안검사, 요검사, 혈액학적 및 혈액생화학적 검사, 부검 시 장기의 중량측정, 부검 시 육안적 검사 및 조직병리학적 검사 등을 평가하였다. 90일 반복경구투여 실험결과로서, 시험물질투여 및 관찰기간 동안 사망동물은 발생하지 않았다. 또한 일반증상, 체중 변화, 사료섭취량, 안과학적 검사, 요검사 그리고 혈액학적 및 혈액이화학적 이상 및 혈액응고검사에서 대조군 대비 특이한 변화는 관찰되지 않았다(p<0.05). 부검 및 병리조직학적 평가 결과, 암수 모두에서 시험물질-유래 중요한 변화 없이 시험물질-유래 경미한 변화(non-adverse effect)만인 5,000 mg/kg/day에서 확인되었다. Weight-based classification(독성 강도에 따른 분류)을 적용한 최종 독성평가 결과, 수컷의 경우 NOEL(No Observed Effect Level)은 5,000 mg/kg/day 그리고 암컷의 경우는 NOAEL(No Observed Adverse Effect Level)은 5,000 mg/kg/day로 최종 확인되었다. 따라서, 암수 모두에서 시험물질의 NOAEL은 투여최대용량인 5,000 mg/kg/day로 확인되었다. 결론적으로, GMP를 원료로 하여 제조한 7%-GNANA(유청가수분해단백분말)는 투여가능 최대용량에서도 독성이 없는 안전한 천연물이라는 것을 확인하였고, 의약품이나 기능성 식품으로서의 개발 가능성을 확인하였다.

• 대한약침학회지
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• 제26권4호
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• pp.348-356
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• 2023

Objectives: Neuralgia-pharmacopuncture (NP) was recently developed as a water-soluble type of pharmacopuncture inspired by CS (care special pain)-pharmacopuncture. I aimed to evaluate the toxic response and approximate lethal dose of when NP when administered intramuscularly to Sprague Dawley rats. Methods: The experimental group was divided into the NP test substance group and the saline control group and administered at a dose of 1.0 mL/animal to the posterior thigh muscles on both sides using a 1 mL syringe; each group consisted of five males and five females. Each rat was monitored for clinical signs and changes in body weight for 14 days after a single intramuscular injection. After completing observation, necropsy findings and localized tolerance at the injection site were assessed via gross necropsy and histopathological examination. Results: No deaths occurred in the NP or control group, regardless of sex. During the observation period, no changes (such as general symptoms, weight change, or visual observation results at the time of autopsy) were judged to be due to the test substance. Histopathological examination showed no changes at the administration site judged to be caused by the test substance in either the male or female test substance administration groups. In addition, mononuclear cell infiltration of the outer membrane of the femoris muscle at the administration site was observed at the same frequency and extent in the control and NP groups, and was judged to be caused by physical stimulation by the injection needle; therefore, it had no toxicological significance. Conclusion: Based on the above results, the approximate lethal dose for a single intramuscular administration of the test substance NP in Sprague-Dawley rats was judged to be > 1.0 mL/animal, and there were no findings that were judged to be due to the test substance at the administration site.

• Environmental Analysis Health and Toxicology
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• 제21권2호
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• pp.173-184
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• 2006

From the harmfulness expectation test conducted through a toxicity anticipation program, methylcyclohexane turned out to be harmful and simulative, but no carcinogenicity was anticipated. In a four-hour acute inhalation toxicity test, the result showed that lethal concentration ($LC_{50}$) was 3,750 ppm (15,054 mg/L), which was identified as a harmful substance on the basis of the harmful substance classification standard $2 of the Industrial safety and health law. methylcyclohexane fell under the category $4(2,500 substance from the GHS standard acute toxicity harmfulness classification. Also, from subchronic inhalation toxicity test that included 6 hours a day, five days a week, and for 13 weeks, we could observe weight, activity, long term weight, blood and blood biochemical influence from the exposure of test substance. No-observed effect level (NOEL) was determined below $100{\sim}400ppm$ inboth male and female. This material falls under the Category 2 ($50{\sim}250ppm/6hours/90days$) in the GHS (Globally Harmonized System) standard trace long-term whole body toxicity repeated exposure, and can be classified as a harmful substance in accordance with the Industrial Safety and Health Law harmful substance standard $NOEL{\leq}0.5mg/L/6hr/90day$ (rat).

• 약학회지
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• 제58권1호
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• pp.62-70
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• 2014

A 28-day repeated-dose oral toxicity test was performed to determine the no-observed-effect level (NOEL) and establish an optimum dose of the highly toxic Aconiti Ciliare Tuber (ACT) used as a folk remedy. Repeated oral doses of 1,250, 2,500, and 5,000 mg/kg/day of the hot water extract of ACT were administered to five male and five female Sprague-Dawley rats in each group for 4 weeks. The indicators for toxicity included results of examination of common symptoms and changes in weight and feed intake, eye test, urinalysis, hematological and serum biochemical analyses, and post-mortem weight measurement of organs, and visual inspections. All animals survived at the end of the experiment; in addition, we observed no specific test substance-mediated symptoms. We observed no test substance-mediated changes in body weight and feed intake. We observed statistically significant changes in male OB and pH levels (p<0.05). Further, the biochemical test showed statistically significant changes in the IP value of male rats and $CL^-$valueoffemalerats (p<0.05). However, all changes were within historical data. The post-mortem examinations showed no test substance-mediated changes. Moreover, statistically significant changes under the test conditions were confirmed to have been caused by factors other than the test substance. Thus, the maximum NOEL of ACT extract in rats was estimated to be 5,000 mg/kg/day.

• 보건교육건강증진학회지
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• 제20권3호
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• pp.61-76
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• 2003

Substance abuse among teenagers has been spreading widely and become a serious social problem. However, teachers hardly realize its importance. Recently, substance abuse prevention programs show a tendency towards one time education. This study aims to research the effect of substance abuse prevention on high school students using the Life Skills Training Program. Two classes(36 students in the experimental group, 35 in the control group) at W High School in Daejeon were randomly sampled for this study from May to June 2002. Substance knowledge and attitude, problem solving, and assertiveness were examined as Pre and Post-Tests. The data was analyzed using frequencies, t-test, means, and covariance(ANCOVA). The results of this study were as follows； 1. Compared with the control group, substance knowledge in the experimental group was significantly improved(F＝176.317, P＝.000). And compared with the control group, substance attitudes in the experimental group were improved significantly.(F＝207.682, P＝.000). 2. Compared with the control group, cognitions to problem solving in the experimental group was significantly improved(F＝100.937, P＝.000). 3. Compared with the control group, assertiveness behaviors in the experimental group were increased significantly(F＝207.255, P＝.000). The study showed that Substance Abuse Prevention of High School Students was effective in improving substance knowledge and attitude, cognition to problem solving, and assertiveness behavior. Some suggestions based on the result are as follows； 1. Substance abuse preventive programs must be practiced properly and systematically with high school students in their regular classes. 2. Various preventive education programs must be developed for substance abuse where high school students can join in a community center, such as Community Welfare Center, Alcoholic Counseling Center, and Mental Health Center. 3. For the furthering of substance abuse preventive education, there must be continued research about not only students with problems of substance misuse and abuse, but also students without them. 4. There must be early determination of students with problems of substance misuse to be able provide school social workers with the opportunity for intervention.

• Asian Pacific Journal of Cancer Prevention
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• 제17권8호
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• pp.4113-4116
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• 2016

Background: Acceptance and commitment therapy (ACT) increases the psychological flexibility of people afflicted with cancer, and consequently improves their adaptability. The present research was conducted with the aim of determining the effectiveness of ACT for people afflicted with cancer. Materials and Methods: The present research was of semi-pilot type with a pre-test and post-test plan for the proof group. The demographics of the community were composed of all the women with cancer who were under treatment in Tehran's Dehshpour therapeutic center in 2015. The sample was composed of 24 people who were selected as available and chosen randomly in two groups of test and proof. All the participants responded to Snyder questionnaire in two pre-test and post-test stages, and the test group participated in treatment sessions after conducting the pre-test. Results: After collecting the information, data analysis was conducted in two description and inferential levels. The test results of covariance analysis showed that the two groups' hope was meaningfully different. Hope in the test group, compared to the proof group, increased meaningfully. Conclusions: The results show that the ACT is effective in increasing hope of patients with cancer.

• Korean Journal of Acupuncture
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• 제39권2호
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• pp.54-62
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• 2022

Objectives : The purpose of this study was to evaluate the potential of the test substance, SU-Eohyeol Pharmacopuncture (SUEP), to induce micronuclei in bone marrow cells of Sprague-Dawley (SD) Rats. Methods : The dose range preliminary study was performed first. 1 ml/animal was selected as the high dose of this study. Two additional lower dose levels (0.5 and 0.25 ml/animal) were produced by applying a geometric ratio of 2. In addition, the positive and negative control groups were set. Then, after intramuscular administration (1 ml/animal) of SUEP to 8-week-old male SD rats, an in vivo micronucleus test was performed to evaluate the induction of micronuclei in SD rat bone marrow cells. Results : As a result of the main study, the incidence of micronucleated polychromatic erythrocytes (MNPCE) in polychromatic erythrocytes (PCE) in the test substance SUEP groups was not statistically significantly different from the negative control group. In addition, the ratio of PCE to total erythrocytes in the test substance SUEP groups was not statistically significantly different from the negative control group. In the positive control group, the incidence of MNPCE in PCE was statistically significantly increased when compared to the negative control group. The ratio of PCE to total erythrocytes in the positive control group was not statistically significantly different from the negative control group. Conclusions : Based on these results, the test substance, SUEP, did not have any potential to induce micronuclei formation in bone marrow cells of rats under the conditions of this study.

• 대한예방한의학회지
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• 제3권2호
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• pp.91-100
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• 1999

Today, toxicology is used for many purpose, in many fields. Classification of special toxic effect is related next 4 important principles. 1. The chemical substance must move to target organ or tissue that can induce Biological effect. For this movement, we have to understand the physical-chemical characteristic of substance, and the rout of absorption, metabolism, diffusion and excretion of toxic substance. 2. Every biological effect that induced by chemical substance is not harmful. For example, some specific chemical substance is not harmful in liver enzyme system. 3. The strength of biological effect induced by chemical substance is deep related with dose. Nearly all substance is not effective below the specific dose, and it may toxic to death over the specific dose. It is the 'Dose - response relationship' But carcinogen may toxic whether it is law dose or not. 4. The information that was obtained by experimental animal test, could have to adapt in human biology. Because biological effect of chemical substance could be different in every biological species. In past, drugs was obtained by animal or plants. But in the future, it could be obtained by biochemistry, and genome project. Therefore, in Oriental medicine, research and approach is needed at this time, and have to develop new method of experience in toxic method.