• 제목/요약/키워드: drug classification system

검색결과 79건 처리시간 0.026초

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

  • 손현순;신현택;송인숙;전효정
    • 한국임상약학회지
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    • 제16권2호
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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
    • 대한약학회:학술대회논문집
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    • 대한약학회 2002년도 Proceedings of the Convention of the Pharmaceutical Society of Korea Vol.2
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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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전립선염(前立腺炎) 외치법(外治法)에 대한 문헌적(文獻的) 고찰(考察) (The literature of External therapy for prostatitis)

  • 김대복;조충식;김철중
    • 혜화의학회지
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    • 제11권1호
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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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시험관내 용출 및 장관막 투과도와 생체이용률과의 상관성 (The Relationship of in vitro Dissolution and Intestinal Membrane Permeability with in vivo Bioavailability)

  • 서수경;손수정;박인숙;최기환;김순선;유태무;조혜영;이용복;김동섭
    • 약학회지
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    • 제44권5호
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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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약물역학분야의 한약연구동향 (Current Research Trend of Herbal Medicine in Pharmacoepidemiology)

  • 우연주
    • 대한예방한의학회지
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    • 제22권3호
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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.

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

  • 채민경;방준석;이유정
    • 한국임상약학회지
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    • 제23권1호
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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.

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

  • 이미경;이서래;박성관;홍기형;이달수;장영미;권용관;박성국
    • 한국식품위생안전성학회지
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    • 제21권1호
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    • pp.14-22
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    • 2006
  • 국내와 Codex에서의 식품첨가물 사용기준패턴 및 식품분류방법에 따른 차이 때문에 양자간의 첨가물 사용기준을 비교하는 데 많은 어려움이 예상되었다. 따라서 본 연구에서는 benzoic acid, food red No. 2, sulfur dioxide, polysorbate 60에 대해 첨가물별 사용기준 대조표와 된장, 고추장, 라면에 대해 식품별 사용기준 대조표를 작성하였다. 첨가물별 사용기준 대조표의 작성에서는 식품분류방법에서의 차이 때문에, 그리고 식품별 사용기준 대조표에서는 국내 첨가물 사용기준 설정 패턴의 혼용 때문에 많은 문제점과 어려움이 있었다. 본 연구에서 제시한 사용기준대조표는 규제당국 및 식품산업계에서 긴요하게 활용될 수 있을 것이며 사용기준의 국가간, 식품간 비교시 세심한 주의가 요구된다는 점을 보여주었다.

Application of metabolic profiling for biomarker discovery

  • Hwang, Geum-Sook
    • 한국응용약물학회:학술대회논문집
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    • 한국응용약물학회 2007년도 Proceedings of The Convention
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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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국가 감염병 공동R&D전략 수립을 위한 분류체계 및 정보서비스에 대한 연구: 해외 코로나바이러스 R&D과제의 분류모델을 중심으로 (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)

  • 이도연;이재성;전승표;김근환
    • 지능정보연구
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    • 제26권3호
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    • pp.127-147
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    • 2020
  • 세계는 신형 코로나바이러스 감염증(COVID-19)으로 수 많은 인명 피해와 경제적 손실을 기록하고 있는 상황이다. 우리나라 정부는 연구개발(Research & Development)을 통해 국가 감염병 위기를 극복하려는 전략을 수립하고 실행하기 위한 투자방향을 수립하였다. 기존 기술분류나 과학기술 표준분류에 따른 통계를 활용하면 특정 R&D 분야의 특이점 및 변화를 발견하기 어렵다는 한계가 존재해왔다. 최근 우리나라 감염병 연구개발 과제를 대상으로 수요자의 목적에 맞게 분류체계를 수립하고 연구비 비교 분석을 통해 투자가 요구되는 연구 분야를 제시하는 연구들이 진행되었다. 하지만 현재 국가 보건 안보와 신성장 산업육성이라는 목표를 달성하기 위한 실행방안으로 요구되고 있는 전염병 연구분야의 국가간 협력전략 수립에 필요한 정보를 체계적으로 제공하고 있지 못한 상황이다. 따라서 국가 공동 연구개발 전략 수립을 위한 분류체계와 분류모델기반의 정보서비스에 대한 연구가 요구되고 있다. 우선 감염병관련 NTIS 과제데이터를 기반으로 정성분석을 통해 7개의 분류체계를 도출하였다. 스코퍼스(Scopus) 데이터와 양방향 RNN모델을 사용하여, 분류체계 모델을 학습시켰다. 최종적인 모델의 분류 성능은 90%이상의 높은 정확도와 강건성을 확보하였다. 실증연구를 위해 주요 국가의 코로나바이러스 연구개발 과제를 대상으로 전염병 분류체계를 적용하였다. 주요 국가의 감염병(코로나바이러스) 연구개발 과제를 분류체계별로 분석한 결과, 세계적으로 유행하는 바이러스의 예상치 못한 창궐이 확산되는 속도에 비해 백신과 치료제 개발이 제대로 이뤄지지 않는 원인의 배경을 간접적으로 확인할 수 있었다. 국가별 비교분석을 통해 미국과 일본은 상대적으로 모든 영역에 골고루 연구개발 투자를 하고 있는 것으로 나타난 반면, 유럽은 상대적으로 특정 연구분야에 많은 투자를 하는 집중화 전략을 취하는 것으로 나타났다. 동시에 주요 국가의 코로나 바이러스 주요 연구조직에 대한 정보를 분류체계별로 제공하여 국제 공동R&D 전략의 기초정보를 제공하였다. 본 연구 결과를 통해 세 가지 정책적 의미를 도출할 수 있다. 첫째, 데이터기반 과학기술정책 관점에서 수요자 관심분야에 대한 국가 R&D사업의 정보를 글로벌 기준으로 문서를 분류하는 방안을 제시하였다. 둘째, 감염병관련 국가 R&D사업 영역에 대한 정보분석 서비스 기획의 기반을 마련하였다. 마지막으로 국가 감염병 R&D 분류체계 수립을 통해 분류 체계의 궁극적 목표인 산업, 기업, 정책 정보를 제공할 수 있는 기반을 마련한 것이다.

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

  • 홍성정;이성희;김화선
    • 여성건강간호학회지
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    • 제17권3호
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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.