• Title/Summary/Keyword: Quasi-drug

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A Proposal for Research Process of Botanical Drug based Clinical Traditional Korean Medicine - Historical Evidence-Based Medicine II - (한의학임상에 기초를 둔 천연물신약 연구과정에 대한 소고 - 역사적 근거 발굴부터 천연물신약 임상시험계획승인신청까지 -)

  • Eom, Seok-ki;Kim, Se-hyun;Kim, Kyung-suk;Park, Sang-jae;Eo, Wan-kyu;Choi, Won-cheol
    • Journal of Korean Medical classics
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    • v.23 no.4
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    • pp.63-102
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    • 2010
  • Purpose : To propose various types of clinical research which is feasible for botanical new drug (IND) development processes, and suggest essential steps to development of study protocol for IND. Methods : Literature-based discussions and one research group's experience is given regarding domestic act, regulation, and system. Results : In order to get an approval of IND for botanical drug in Korea there are several types of clinical research to conduct. In quality control steps for standardized medicinal herbs, case reports or case series can be conducted, and for good manufacturing practice(GMP) steps, we can conduct case reports, case series, and retrospective cohort studies. In addition, as long as we gathered good laboratory practice(GLP) data we can conduct up to quasi-experimental studies and clinical trials including investigator initiated trials. In order to conduct these studies development of study protocol is essential. First, we obtain historical evidence including target disease and indication, efficacy, safety, and endpoints by reviewing medical classics. Second, we obtain clinically and statistically important data by conducting non-clinical studies, observation studies, and quasi-experimental studies. Third, we generate research hypotheses and purposes and explore methodologies, endpoints, clinical practice guidelines, cost-effectiveness, and commercial potential. Finally, we develop study protocol with aid of biostatistician or expert in contract research organization. Discussions and conclusions : This study have obvious limitations in that most thoughts, suggestions, and proposes are from one research group's experience. Therefore, we hope to see various types of research in this topic and process from other research group as well.

The Development and Effects of WEB Instruction Programs for Drug Abuse Prevention in Korean Adolescents (청소년의 약물남용예방을 위한 웹 활용 학습 프로그램 개발 및 효과)

  • Min, Young-Sook
    • Journal of Korean Academy of Nursing
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    • v.30 no.4
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    • pp.1055-1065
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    • 2000
  • The purpose of this study was to develop, through the integration of instructional theory, a Courseware and to investigate the effectiveness of a web-based computer assisted instruction(WBI) program for preventing drug abuse, a serious problem for youth problem. During the first stage of this study done "Drug Abuse Prevention" Courseware was developed based on, Gagn & Brigg's instructional design theory, Keller's ARCS theory and the CAI model of Hannafin & Peck. For the second stage, the courseware was used to provide education for students adolescents in drug abuse prevention. This study used an quasi-experimental, one-group pretest-posttest design with a convenience sample of 36 male high school students who were at one high school located in Seoul. Data were collected using self-reported questionnaires which included a learning achievement tool, the Keller's IMMS (Instructional Material Motivation Survey), on attitudes to drug use, and on responses to the WBI instruction. Prior to the experiment, the "drug abuse prevention" learning method and the procedures of the study were explained to the students, and then the learning achievement of the subjects was measured as a pretest. The students were then given 2 weeks WBI utilizing the courseware. A post-test which included the pre-test learning achievement questionnaire and a survey of learning motivation and attitudes toward drug were given two weeks after the education was completed. The data analysis was done using SPSS/PC. Paired t-test was used to analyze the differences between the pre-test and post-test scores for learning achievement. The results of the analysis are as follows: There were significant differences in learning achievement between the pre-test and post-test(t=-18.62, p=0.000). The hypothesis, that learning achievement will be higher, after the class has used the courseware, than before was supported. The scores for learning motivation and attitudes toward drugs were also higher than the results of existing studies. In conclusion, this study suggests that WBI is an effective learning method in the prevention of drug abuse for adolescents as it can be used for self-learning and repeated learning as assisted instruction. Recommendation would be given that further research needs to be develped in the courseware by cognitive learning style and by multimedia courseware and virtual reality system.

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Investigation for the Management Methods of Pure Tar Color Additives for Drugs and Quasi-drugs (의약품과 의약외품에 사용되는 타르순색소의 관리방안을 위한 조사연구)

  • Kim, Kwang Joon;Kim, Ji Yeon;Park, Sunhee;Bang, Joon Seok;Lee, Wonjae
    • Korean Journal of Clinical Pharmacy
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    • v.23 no.2
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    • pp.97-105
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    • 2013
  • Background: This study was aimed to establish the systematic management methods of tar color additives used in Korea for drugs and quasi-drugs. Although tar color additives have been used in various areas, safety problems are continuously being reported by several studies. For that reason, major countries like US, Japan, Europe are trying to update the safety information of tar color additives and the related management methods, and Korea also need to complement them based on the updated information for their safer use. Method: This report includes the compared information of all legally used tar color additives of each country, such as color additive name, compound name and chemical abstracts service registry number. Conclusion: It is expected that these investigated results will be useful as the basic materials for proper management guidelines of tar color additives in Korea.

Efficacy Evaluation of Anti-wrinkle Products in Japan

  • Masaki Hitoshi
    • Journal of the Society of Cosmetic Scientists of Korea
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    • v.29 no.2 s.43
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    • pp.67-77
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    • 2003
  • Two categories of cosmetic products, cosmetics and quasi-drugs, have been established by the Ministry of Health, Labor and Welfare (MHLW) in Japan. Japanese pharmaceutical law has defined that products categorized as cosmetics do not exhibit any effects on human skin. In fact, cosmetic products are not permitted to claim any efficacy. On the other hand, products in the quasi-drug category can claim several efficacies such as anti-inflammatory effects, whitening/lightning effects, hair growth effects and so on. Unfortunately, the Japanese MHLW has not yet approved the efficacy of anti-aging/anti-wrinkle effects as a claim point. However, the population is aging, and the demand for anti-aging/anti-wrinkle products is increasing year by year. Japanese cosmetic companies have proposed to the MHLW that anti-aging/anti-wrinkle agents be approved as a claim concept of a quasi-drug. However, unified evaluation methods for anti-aging/anti-wrinkle effects have not been established. Currently, each company evaluates the efficacy of products/materials using their own original methods. Thus, to request approval of the MHLW, the establishment of a unified evaluation method is needed. Consequently, the Japan Cosmetic Industry Association (JCIA) has established a task force to develop guidelines for evaluating anti-wrinkle effects in 1998. In conclusion, the JCIA would like to adopt visual and image analysis scales to evaluate the anti-wrinkle effects objectively. Generally, wrinkles are roughly classified into three groups as fine wrinkles, linear deep wrinkles and crow's feet. However, academic societies of dermatology or cosmetics have not yet established a definition of wrinkles in Japan. Thus, in advance of setting up an evaluation method, the definition of wrinkles f3r evaluation must be decided. Wrinkles are defined by the task force of the JCIA as follows; furrows that people can recognize visually and that appear on the forehead, the corners of the eyes and the backs of the neck with aging. In addition, furrows are emphasized by exposure to solar light and by dry conditions. Visual evaluation is the most sensitive method and can be applied to most types of wrinkles. However, visual evaluation is hard to express digitally as results. Besides, in the case of image analysis, comparisons of data obtained from distinct examinations can not be done, because data from image analysis are relative values. Thus, to enhance the reliability of the evaluations, the adoption of an objective scale was required. The principle of the evaluation method is to analyze images taken from silicone replicas of wrinkle areas using several parameters, such as the proportion of the wrinkle $area({\%})$, the mean depth of the wrinkles (mm), the mean depth of the deepest wrinkle (m) and the deepest point on the deepest wrinkle. Lights are shown on the skin replica from an orthogonal direction of the main orientation of the wrinkle, and the resulting shadow images are quantified by the image analysis method. To increase the precision of the data or to allow comparisons of independent examinations, a scale with furrows of several depths, 200, 400, 600, 800, and $1000{\mu}m$, is adapted in the evaluation system. I will explain the guidelines established by the JCIA in the presentation.

Review of Nursing Research on Psychotropic Drugs in Korea (정신약물 복용과 관련된 국내 간호연구의 고찰)

  • Lee, Jongeun;Bae, Jeongyee;Im, Sookbin
    • Journal of Korean Public Health Nursing
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    • v.27 no.2
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    • pp.338-356
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    • 2013
  • Purpose: This study critically reviewed nursing research psychotropic drugs that has been published in Korean journals. Another aim of this study was to identify trends in nursing research on psychotropic drugs and make suggestions for further study in Korea. Methods: Data were collected from degree theses and original articles on psychotropic drugs published in Korean journals from 1992 to 2013. Thirty-four articles were analyzed of which at least one nursing author participated in the study. Search keywords were "psychotropic drug" and "mentally ill patient & medication". Results: For the research design, quasi-experimental study was 58.8%, descriptive study was 17.7%, descriptive correlational study was 8.8%, qualitative study was 8.8% and model development research was 5.9%. Variables measured were knowledge of medication & symptom management, knowledge of disease, side effects, drug attitude, medication pattern, diet & activity, quality of life, and self-care. Conclusion: Despite recent increased interest in psychiatric medication, research on psychotropic drugs remains very limited, particularly regarding findings from a nurse's perspective. More research project should be designed to develop programs for the treatment of side effects from a nursing view-point.

Effects of a Full Body Massage on Uterine Contraction, Length of Labor, Type of Delivery, and Drug Intervention for Primipara during Labor (분만 중 전신마사지가 초산부의 자궁수축, 분만소요시간, 분만형태 및 약물사용에 미치는 효과)

  • Lee, Kun-Ja;Chang, Chun-Ja;Jo, Hyun-Sook;Kim, Mi-Ran
    • Women's Health Nursing
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    • v.8 no.4
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    • pp.538-549
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    • 2002
  • This study was designed to test the effects of a full body massage on uterine contraction, length of labor, type of delivery, and drug intervention for primipara during labor. Data were collected using a quasi-experiment method (nonequivalent control group, pre-post test design) from November 1, 2001 to July 31, 2002. The subjects of this experiment consisted of 28 women in the experimental group and 29 in the control group, out of 57 primipara hospitalized at the U OB & GYN hospital in Inchon. The experimental group was given a 20 minute full body massage for each of the three delivery phases (latent, active, and transition). The control group was given conventional delivery care. Three (3) parameters were analyzed in this experiment. (1) The interval, duration, and strength of uterine contraction, using an electric tocodynamometer (2) The elapsed time for stage 1 and stage 2 labor. (3) The types of deliveries and drug interventions, using postpartum medical records The data collected were analyzed using the repeated measures analysis of variance (ANOVA), t-test, and $x^2$ test of the SPSS program. The results of the experiment are as follows: 1) Uterine contraction interval was significantly reduced (F=3.210, p=.050). Duration of uterine contraction showed significant increase only during the transition phase (t=-2.319, p=.023). Strength of uterine contraction showed no significant difference. 2) Total length of labor was significantly shortened (t=-5.245, p=.000). The length of 1st stage labor was significantly shortened (t=-5.164, p=.000), with latent phase showing (t=-4.709, p=.000), active phase (t=-2.973, p=.005), and transition phase (t=-2.031, p=.047). The length of 2nd stage labor showed no significant difference. 3) The number of natural deliveries were significantly increased ($x^2$=13.127, p=.004). 4) The number of drug interventions were significantly fewer ($x^2$= 4.493, p=.034). In conclusion, this study shows that a full body massage has a significantly positive effect on uterine contraction interval, length of labor, type of delivery, and drug intervention. Therefore, this study suggests that a full body massage be used clinically to help primipara during labor.

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The Effects of Nursing Education about Recognition on Adolescent Problem Behaviors (청소년 문제행동인식에 관한 간호교육의 효과)

  • Park, Young-Suk
    • The Journal of Korean Academic Society of Nursing Education
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    • v.18 no.2
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    • pp.276-283
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    • 2012
  • Purpose: This study was carried out to identify the effects of classroom lectures on adolescent nursing education in distance education. Method: The design of this study was a quasi-experimental research with nonequivalent control group, pretest-posttest design. The subjects of this study were 434 nurses in K open university. Data were collected from April to June, 2009 by the adolescent delinquency measurement scale and questionnaire for awareness of the issue in adolescent health education. Result: The both groups perceived the biggest problem as the lack of assigned education time in adolescent health education. After receiving education, the experimental group improved significantly more than the control group in recognition of adolescent problem behavior which is in interpersonal, intermaterial, order, drug, sex, position, alcohol/smoking delinquency and psychiatric problem. Conclusion: This adolescent nursing education is an effective education for nurses and could improve their recognition of adolescent problem behavior.

The Fundamental Understanding Of The Real Options Value Through Several Different Methods

  • Kim Gyutai;Choi Sungho
    • Proceedings of the Korean Operations and Management Science Society Conference
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    • 2003.05a
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    • pp.620-627
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    • 2003
  • The real option pricing theory has emerged as the new investment decision-making techniques superceding the traditional discounted cash flow techniques and thus has greatly received muck attention from academics and practitioners in these days the theory has been widely applied to a variety of corporate strategic projects such as a new drug R&D, an internet start-up. an advanced manufacturing system. and so on A lot of people who are interested in the real option pricing theory complain that it is difficult to understand the true meaning of the real option value. though. One of the most conspicuous reasons for the complaint may be due to the fact that there exit many different ways to calculate the real options value in this paper, we will present a replicating portfolio method. a risk-neutral probability method. a risk-adjusted discount rate method (quasi capital asset pricing method). and an opportunity cost concept-based method under the conditions of a binomial lattice option pricing theory.

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The Effects of Aroma Foot Reflex Massage on Sleep, Depression and Problem Behaviors on Elderly with Dementia (아로마 발반사 마사지가 경증 치매노인의 수면, 우울 및 문제행동에 미치는 효과)

  • Yang, Hee-Jeong;Kang, Hee-Young;Kim, In-Sook
    • Korean Journal of Adult Nursing
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    • v.23 no.6
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    • pp.574-583
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    • 2011
  • Purpose: The purpose of this study was to evaluate the effects of aroma foot massage and reflexology on sleep, depression and problem behaviors on elderly with dementia. Methods: The study was a none equivalent control group pre-post test quasi-experimental design. The participants were 62 elderly with mild mentia. Using a coin toss, 31 participants were assigned to the experimental group and 31 to the control group. The aroma reflex foot massage comprised of aroma foot massage and foot reflexology. The intervention was conducted twice a week for six weeks. Results: There were significant differences in reported sleep and depression between the two groups. However, the issue of problem behaviors was not significant. Conclusion: Aroma reflex foot massage can be utilized as an effective intervention for sleep and depression in conjunction with drug therapy for the management of elderly with mild dementia.

Medication Status and the Effects of a Medication Management Education Program for the Elderly in a Community (지역사회 노인의 약물복용실태와 약물관리 프로그램의 효과)

  • Park, Young-Im;Lee, Kang-Yi;Kim, Dong-Oak;Uhm, Dong Choon;Kim, Ji-Hyun
    • Research in Community and Public Health Nursing
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    • v.25 no.3
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    • pp.170-179
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    • 2014
  • Purpose: This study investigated medication status by examining the effects of a medication management education program on the knowledge of medications and medication misuse behaviors in the elderly in a local community. Methods: This study used a non-equivalent control group quasi-experimental design. For the study, 116 subjects were assigned to the control group and another 116 subjects were assigned to the experimental group. The medication management education program consisted of 1:1 education, practice in medication management, consultation, and discussion. Data were analyzed using the SPSS 21.0 program. Results: Statistically significant differences were found between the experimental and control groups in terms of their knowledge of medications and medication misuse behaviors. Conclusion: The results indicate that the medical management education program is effective in improving the knowledge of medications and decreasing medication misuse behaviors. Therefore, this education program can be used as an intervention to improve the medication behaviors of the elderly in local communities.