• Title/Summary/Keyword: drug classification system

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Regulatory System of Quasi-drugs in Korea (우리나라 의약외품 허가심사제도 고찰 및 개선 방안)

  • Sohn, Hyun-Soon;Shin, Hyun-Taek;Song, In-Sook;Jun, Hyo-Jung
    • Korean Journal of Clinical Pharmacy
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    • v.16 no.2
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    • pp.123-130
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    • 2006
  • The study was aimed to recommend the ways for improving regulatory system of quasi-drugs in governmental authority by comparing with other countries. According to the regulations, the scope of quasi-drugs includes 3 categories of 1) the health aids made of textile, rubber and paper, 2) the health aids which have very minimal effects or no any effects on humans, and 3) disinfectants and pesticides. In US, these quasi-drugs in Korea are classified into 5 categories of medical device, cosmetics, OTC drugs, dietary supplements and pesticides. To improve quasi-drugs administration in Korea, it is concluded that several measures should be implemented : 1) establish clear criteria for classifying into quasi-drugs and more detailed guidelines on designation of quasi-drugs, 2) reform current regulations to meet 3-categories characteristics, supplement detailed guidelines on quasi-drugs administration for effective application process, and update relevant regulations for efficacy, safety and quality, 3) update quasi-drug monographs, 4) re-evaluate current classification of individual quasi-drugs, 5) develop comprehensive list by ingredients, 6) reform post-marketing management system for safety and quality, 7) strengthen the review agency function by increasing the number of experts, 8) develop the database for quasi-drugs for effective information management.

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THE RELATIONSHIP OF INTESTINAL ABSORPTION CLEARANCE AND PARTITION COEFFICIENT OF NINE BETA-BLOCKERS IN RATS

  • Cho, Hea-Young;Lee, Suk;Kang, Hyun-Ah;Lee, Yong-Bok
    • Proceedings of the PSK Conference
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    • 2002.10a
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    • pp.411.3-412
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    • 2002
  • On the basis of recognizing that physicochemical properties (lipophilic/hydrophilic), intestinal absorption clearance and pharmacokinetic characteristics of drug are the fundamental parameters controlling the rate and the extent of drug absorption, the biopharmaceutics classification system for the correlation between drug lipid- solubility and intestinal absorption clearance is proposed. (omitted)

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The literature of External therapy for prostatitis (전립선염(前立腺炎) 외치법(外治法)에 대한 문헌적(文獻的) 고찰(考察))

  • Kim, Dae-bok;Cho, Chung-sik;Kim, Chul Jung
    • Journal of Haehwa Medicine
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    • v.11 no.1
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    • pp.91-101
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    • 2002
  • According to the literature on the, the results were as follows. 1. The mechanism of External therapy for prostatitis is some medicicne to come into prostate have anti-inframation and the other medicine to come into nerve system control pain. 2. For the method are uesed hip bath, enema and sticking the pacth to the umbilicus etc. 3. For the medicine are used safflower(紅花), patrinia(敗醫草), chrysanthemum flower(菊花) and Cortex Phellodendri(黃栢). nature and flavor of the medicine is almost cold, bitter in taste and hot in taste. 4. For the classification of medicine are used drug to induce diuresis to elominate stranguria(利尿通淋藥) and drug to induce diuresis to dispersing swelling(利水退腫藥). sometimes they are used to Heat-clearing and detoxifying drug(淸熱解毒藥) and blood-quickening aget(活血祛瘀藥).

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The Relationship of in vitro Dissolution and Intestinal Membrane Permeability with in vivo Bioavailability (시험관내 용출 및 장관막 투과도와 생체이용률과의 상관성)

  • 서수경;손수정;박인숙;최기환;김순선;유태무;조혜영;이용복;김동섭
    • YAKHAK HOEJI
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    • v.44 no.5
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    • pp.424-431
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    • 2000
  • A biopharmaceutics drug classification system for correlation between in vitro dissolution and in vivo bioavailability is proposed based on recognizing that drug dissolution and gastrointestinal permeability are the fundamental parameters controlling the rate and extent of drug absorption. The objective of this study was to assess whether in vitro dissolution profiles of immediate-release beta-blocker tablets can be correlated with intestinal membrane permeability and/or in vivo bioavailability In vitro dissolution of the beta-blocker tablets was examined using KP VII Apparatus II methods at various pH. Intestinal membrane permeability was determined in vitro using the diffusion chamber method. Bioavailablity parameters were cited from literatures. The dissolution profiles did not accurately represent the in vivo bioavailablity However there were good correlations between intestinal membrane permeability and log P (noctanol/buffer). The correlations obtained in this study indicated that in vitro diffusion chamber method could be used to predict intestinal absorption in vivo.

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Current Research Trend of Herbal Medicine in Pharmacoepidemiology (약물역학분야의 한약연구동향)

  • Woo, Yeonju
    • Journal of Society of Preventive Korean Medicine
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    • v.22 no.3
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    • pp.11-19
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    • 2018
  • Objectives : The aim of this study is to investigate the current research trend of herbal medicine based on the published articles in pharmacoepidemiologic journals. Methods : A total of 3 electronic journals, Pharmacoepidemiology and Drug Safety(PDS), Drug Safety and Journal of Pharmacoepidemiology and Risk Management(JPERM) from January 2013 to August 2018 were used for searching articles about herbal medicine. Selected articles were reviewed and classified under 5 categories-collection of adverse events in herbal medicine, statistical modeling and methodology, pharmaco-epidemiologic outcome study, drug utilization review(DUR), risk management system and regulation. Results : A total of 8 articles were finally included for analysis. 2 articles were categorized in collection of adverse events in herbal medicine, 1 was statistical modeling and methodology, 2 were pharmacoepidemiologic outcome study and 3 were risk management system and regulation. There was no article in DUR. And then pharmacoepidemiologic research trends of herbal medicine were summarized in classification of 5 categories. Conclusions : To sum up with these 8 articles of herbal medicine in pharmacoepidemiologic journals, herbal medicine was of interesting concern among researchers. The need for research on safety and risk management of herbal medicine is steadily increasing, pharmacoepidemiologic research about herbal medicine must be activated in Korea.

Patterns of Over-the-Counter Drug Use and Interactions between Over-the-Counter Drugs and Prescription Drugs in Adults Visiting a Community Pharmacy (지역약국 방문 성인의 일반의약품 복용실태 및 일반의약품과 처방의약품과의 상호작용 연구)

  • Chae, Min Kyoung;Bang, Joon Seok;Lee, Yu Jeung
    • Korean Journal of Clinical Pharmacy
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    • v.23 no.1
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    • pp.49-56
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    • 2013
  • Objective: The purpose of this study was to evaluate the patterns of Over-the-Counter (OTC) drugs and their interactions with prescription drugs in adults visiting a community pharmacy. Method: The subjects were 151 adults aged over 20 years visiting a community pharmacy in Asan-si from December 16th 2011 to February 1st 2012. We used a survey questionnaire. The survey inquired about the prevalence and the details of any OTC drug use and the characteristics of the study subjects. The drug interaction classification system from Lexicomp's Lexi-interact data fields was used to identify OTC drugs likely to have clinically significant interactions with prescription drugs. Results: The patterns of OTC drug use were related to thirties (from 30 to 40 years old), female gender, higher education, non-smoking, sometimes use of alcohol, and self-perceived normal health status. The most commonly used OTC drug category was antipyretic-analgesics (n=104, 53.3%), and the most commonly used ingredient was acetaminophen (n=67, 64.4%). The biggest motivation for taking OTC drugs was suggestion by pharmacists, reported by 55.6%. After reviewing each patient's prescription drugs and OTC drugs, 14 patients (36.8%) of 38 patients using prescription drugs were taking drug combinations with potential for clinically significant interactions. The concomitant use of OTC drugs with prescription drugs may lead to increased potentially harmful interactions. Conclusion: It is suggested that health-care professionals should be more aware of the potential and possible interactions and take into better account their patients' OTC drug use.

Comparison between Use Levels of Food Additives by Codex and Korea (국내 및 Codex에서 식품첨가물의 사용기준 비교)

  • Lee Mi-Gyung;Lee Su-Rae;Park Sung-Kwan;Hong Ki-Hyoung;Lee Tal-Soo;Jang Young-Mi;Kwon Yong-Kwan;Park Seong-Guk
    • Journal of Food Hygiene and Safety
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    • v.21 no.1
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    • pp.14-22
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    • 2006
  • It is anticipated that difficulties are encountered in comparing the use levels of food additives between Korean and Codex systems because of the differences in the use level pattern and food classification method. This study was attempted to construct comparison tables between Korean and Codex standards for benzoic acid, food red No. 2, sulfur dioxide and polysorbate as well as for soybean paste, hot soybean paste and intstant noodle. Difficulties were found to be due to the food category system in use levels by additives and due to the mixed pattern of use level setting in Korea in use levels by food commodities. The comparison tables proposed in this study will be utilized momentously by regulatory authorities and food processing industry. This study showed the necessity to pay attention in comparing the use levels of food additives by country and food commodity.

Application of metabolic profiling for biomarker discovery

  • Hwang, Geum-Sook
    • Proceedings of the Korean Society of Applied Pharmacology
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    • 2007.11a
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    • pp.19-27
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    • 2007
  • An important potential of metabolomics-based approach is the possibility to develop fingerprints of diseases or cellular responses to classes of compounds with known common biological effect. Such fingerprints have the potential to allow classification of disease states or compounds, to provide mechanistic information on cellular perturbations and pathways and to identify biomarkers specific for disease severity and drug efficacy. Metabolic profiles of biological fluids contain a vast array of endogenous metabolites. Changes in those profiles resulting from perturbations of the system can be observed using analytical techniques, such as NMR and MS. $^1H$ NMR was used to generate a molecular fingerprint of serum or urinary sample, and then pattern recognition technique was applied to identity molecular signatures associated with the specific diseases or drug efficiency. Several metabolites that differentiate disease samples from the control were thoroughly characterized by NMR spectroscopy. We investigated the metabolic changes in human normal and clinical samples using $^1H$ NMR. Spectral data were applied to targeted profiling and spectral binning method, and then multivariate statistical data analysis (MVDA) was used to examine in detail the modulation of small molecule candidate biomarkers. We show that targeted profiling produces robust models, generates accurate metabolite concentration data, and provides data that can be used to help understand metabolic differences between healthy and disease population. Such metabolic signatures could provide diagnostic markers for a disease state or biomarkers for drug response phenotypes.

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The Classification System and Information Service for Establishing a National Collaborative R&D Strategy in Infectious Diseases: Focusing on the Classification Model for Overseas Coronavirus R&D Projects (국가 감염병 공동R&D전략 수립을 위한 분류체계 및 정보서비스에 대한 연구: 해외 코로나바이러스 R&D과제의 분류모델을 중심으로)

  • Lee, Doyeon;Lee, Jae-Seong;Jun, Seung-pyo;Kim, Keun-Hwan
    • Journal of Intelligence and Information Systems
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    • v.26 no.3
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    • pp.127-147
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    • 2020
  • The world is suffering from numerous human and economic losses due to the novel coronavirus infection (COVID-19). The Korean government established a strategy to overcome the national infectious disease crisis through research and development. It is difficult to find distinctive features and changes in a specific R&D field when using the existing technical classification or science and technology standard classification. Recently, a few studies have been conducted to establish a classification system to provide information about the investment research areas of infectious diseases in Korea through a comparative analysis of Korea government-funded research projects. However, these studies did not provide the necessary information for establishing cooperative research strategies among countries in the infectious diseases, which is required as an execution plan to achieve the goals of national health security and fostering new growth industries. Therefore, it is inevitable to study information services based on the classification system and classification model for establishing a national collaborative R&D strategy. Seven classification - Diagnosis_biomarker, Drug_discovery, Epidemiology, Evaluation_validation, Mechanism_signaling pathway, Prediction, and Vaccine_therapeutic antibody - systems were derived through reviewing infectious diseases-related national-funded research projects of South Korea. A classification system model was trained by combining Scopus data with a bidirectional RNN model. The classification performance of the final model secured robustness with an accuracy of over 90%. In order to conduct the empirical study, an infectious disease classification system was applied to the coronavirus-related research and development projects of major countries such as the STAR Metrics (National Institutes of Health) and NSF (National Science Foundation) of the United States(US), the CORDIS (Community Research & Development Information Service)of the European Union(EU), and the KAKEN (Database of Grants-in-Aid for Scientific Research) of Japan. It can be seen that the research and development trends of infectious diseases (coronavirus) in major countries are mostly concentrated in the prediction that deals with predicting success for clinical trials at the new drug development stage or predicting toxicity that causes side effects. The intriguing result is that for all of these nations, the portion of national investment in the vaccine_therapeutic antibody, which is recognized as an area of research and development aimed at the development of vaccines and treatments, was also very small (5.1%). It indirectly explained the reason of the poor development of vaccines and treatments. Based on the result of examining the investment status of coronavirus-related research projects through comparative analysis by country, it was found that the US and Japan are relatively evenly investing in all infectious diseases-related research areas, while Europe has relatively large investments in specific research areas such as diagnosis_biomarker. Moreover, the information on major coronavirus-related research organizations in major countries was provided by the classification system, thereby allowing establishing an international collaborative R&D projects.

Analysis of Nursing Interventions Performed by Gynecological Nursing Unit Nurses Using the Nursing Interventions Classification (간호중재분류 (NIC)에 근거한 부인과 간호단위의 간호중재 분석)

  • Hong, Sung-Jung;Lee, Sung-Hee;Kim, Hwa-Sun
    • Women's Health Nursing
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    • v.17 no.3
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    • pp.275-284
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    • 2011
  • Purpose: The purpose of this study was to identify nursing intervention performed by nurses on gynecological nursing units. Methods: The instrument in this study is based on the fifth edition of Nursing Interventions Classification (NIC) (2008). Data was collected by Electronic Medical record from August, 2010 to October, 2010 at one hospital and analyzed by using frequencies in the Microsoft Excel 2010 program. Results: Of a total of 82 NIC, domains of the nursing interventions showed higher percentages for physiological: basic (36.3%) and physiological: complex (34.5%). The classes of nursing interventions showed higher percentage for health system medication (12.1%), perioperative care (10.0%), and drug management (8.6%). The most frequently used top interventions were Discharge Planning. The thirty least used interventions was environmental management. Top thirty most frequently used interventions belonged to the domain of physiological: basic (37.9%), physiological: complex (31.1%), and behavioral (5.4%). Conclusion: These findings will help in the establishment of a standardized language for gynecological nursing units and enhance the quality of nursing care.