• Title/Summary/Keyword: OTC system

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OTC Drug Regulatory System of Korea Comparing to Other Countries (일반의약품 허가제도의 국가간 비교 및 발전 방향)

  • Sohn, Hyun-Soon;Shin, Hyun-Taek
    • Korean Journal of Clinical Pharmacy
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    • v.15 no.2
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    • pp.127-138
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    • 2005
  • This is to examine the OTC regulatory system of Korea in comparison with those of Japan, UK and US, and suggest the possible regulatory actions to harmonize it to international standards. Individual countries have their own regulatory requirements and processes far OTC application based on established drug monographs and safety profiles from clinical experiences. Categories of OTC drug monographs are being expanded with transparent establishment procedure according to detailed guidelines, and public opinions as well as professional experts for assessing appropriateness of wide usage without physician's prescription. In line with trend of self-medication worldwide, the number of OTC drugs is increasing and more efficient and professional drug review is underway in the separate OTC division in regulatory agency. For improving OTC regulatory system in Korea, settlement of optimal drug classification policy and management for encouraging OTC drug use, development of more detailed and specific guidelines for OTC drug application, expansion of OTC drug monographs, transparent process for OTC monographs establishment, and establishment of OTC division in health authority, are suggested.

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Long-term Climate Change Research Facility for Trees: CO2-Enriched Open Top Chamber System (수목의 장기 기후변화 연구시설: CO2 폭로용 상부 개방형 온실)

  • Lee, Jae-Cheon;Kim, Du-Hyun;Kim, Gil-Nam;Kim, Pan-Gi;Han, Sim-Hee
    • Korean Journal of Agricultural and Forest Meteorology
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    • v.14 no.1
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    • pp.19-27
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    • 2012
  • The open-top chamber (OTC) system is designed for long term studies on the climate change impact on the major tree species and their community in Korea. In Korea Forest Research Institute (KFRI), the modified OTC system has been operating since September 2009. The OTC facility consists of six decagon chambers (10 meters in diameter by 7 meters high) with controlled gas concentration. In each chamber, a series of vertical vent pipes are installed to disperse carbon dioxide or normal air into the center of the chamber. The OTC is equipped with remote controlled computer system in order to maintain a stable and elevated concentration of carbon dioxide in the chamber throughout the experimental period. The experiment consisted of 4 treatments: two elevated $CO_2$ levels ($1.4{\times}$ and $1.8{\times}$ ambient $CO_2$) and two controls (inside and outdoors of the OTC). Average operational rate was the lowest (94.2%) in June 2010 but increased to 98% in July 2010 and was 100% during January to December 2011. In 2010~2011, $CO_2$ concentrations inside the OTCs reached the target programmed values, and have been maintained stable in 2011. In 2011, $CO_2$ concentrations of 106%, 100% and 94% of target values has been recorded in control OTC, $1.4{\times}$ $CO_2$-enriched OTC and $1.8{\times}$ $CO_2$-enriched OTC, respectively. With all OTC chambers, the difference between outside and inside temperatures was the highest ($1.2{\sim}2.0^{\circ}C$) at 10 am to 2 pm. Temperature difference between six OTC chambers was not detected. The relative humidity inside and outside the chambers was the same, with minor variations (0~1%). The system required the highest amount of $CO_2$ for operation in June, and consumed 11.33 and 17.04 ton in June 2010 and 2011, respectively.

A Study on Building Electronic Trading System for OTC Derivatives Market Using XML (XML을 이용한 장외파생상품 전자거래시스템 구축방안에 관한 연구)

  • Lim, Byung-Ha
    • International Commerce and Information Review
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    • v.6 no.3
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    • pp.101-119
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    • 2004
  • Since the early 1980's there has been explosive growth in the trading of financial derivatives, particularly in the OTC(over-the-counter) derivatives market. While the market has exploded in term; of growth, much of this activity is still conducted over the phone or fax. Currently, over 2,083 trillion Korean Wons are spent during 2003 by the OTC derivatives industry. XML provides an excellent framework for representing these highly structured products. FpML is the emerging XML-based tool for enabling e-Business in the OTC derivatives market. This paper discusses the application of FpML in building electronic platform designed to promote efficiencies for this market and propose the framework for STP(Straight Transaction Processing) system for OTC derivatives processing which can solve the problems with manual operations.

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Preparation and evaluation of microcrystallized cellulose xanthate-metal-oxytetracycline complexes as antibacterial agents with prolonged antibacterial activity

  • Kong, Hyo-Sik;Lee, You-Na;Lee, Yong-Hyun;Kim, Young-Mi;Jung, Yun-Jin
    • Journal of Pharmaceutical Investigation
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    • v.39 no.2
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    • pp.85-91
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    • 2009
  • Microcrystallized cellulose xanthate-metal-oxytetracycline complexes (MCX-metal-OTC) were prepared and evaluated as a controlled release system for the antibiotics. Microcrystallized cellulose (MC) was chemically modified to xanthated microcrystallized cellulose (MCX). One-bath method, where MCX was reacted with OTC-metal complexes, afforded greater amount of OTC bound to the polymeric matrix than did two-bath method, where MCX-metal complexes were treated with OTC. The OTC release from MCX-metal-OTC was greatly sustained compared with that from a mixture of MC/metal/OTC. Furthermore, MCX-metal-OTC manifested antibacterial activity, which lasted for 11-18 days. These results suggest that MCX-metal-OTC is a polymeric antibiotics with prolonged antibacterial activity.

단순의약품(OTC) 판매제도 개선에 관한 연구

  • 김창호
    • Journal of Distribution Research
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    • v.2 no.2
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    • pp.173-199
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    • 1997
  • The main purpose of this paper is to propose an alternative system of the distribution of OTC drugs in Korea. We first investigate the characteristics and the regulations on the distribution of the Korean medicine market and compare it with some foreign countries. We also examine the buying behavior of Korean customers. We propose three different alternatives. A passive policy is to expand the range of OTC drugs. Another one would be to amend the relevant laws. An active alternative is to arrange a separate organization to control the distribution of OTC drugs. The time and the execution of the proposed policies could vary.

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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.

Anti-fibrotic effects of L-2-oxothiazolidine-4-carboxylic acid via modulation of nuclear factor erythroid 2-related factor 2 in rats

  • Kim, In-Hee;Kim, Dae-Ghon;Hao, Peipei;Wang, Yunpeng;Kim, Seong-Hun;Kim, Sang-Wook;Lee, Seung-Ok;Lee, Soo-Teik
    • BMB Reports
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    • v.45 no.6
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    • pp.348-353
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    • 2012
  • L-2-Oxothiazolidine-4-carboxylic acid (OTC) is a cysteine prodrug that maintains glutathione in tissues. The present study was designed to investigate anti-fibrotic and anti-oxidative effects of OTC via modulation of nuclear factor erythroid 2-related factor 2 (Nrf2) in an in vivo thioacetamide (TAA)-induced hepatic fibrosis model. Treatment with OTC (80 or 160 mg/kg) improved serum liver function parameters and significantly ameliorated liver fibrosis. The OTC treatment groups exhibited significantly lower expression of ${\alpha}$-smooth muscle actin, transforming growth factor-${\beta}1$, and collagen ${\alpha}1$ mRNA than that in the TAA model group. Furthermore, the OTC treatment groups showed a significant decrease in hepatic malondialdehyde level compared to that in the TAA model group. Nrf2 and heme oxygenase-1 expression increased significantly in the OTC treatment groups compared with that in the TAA model group. Taken together, these results suggest that OTC restores the anti-oxidative system by upregulating Nrf2; thus, ameliorating liver injury and a fibrotic reaction.

Comparison of Approval Process for Nonprescription Drugs in Different Countries (비처방의약품 허가 제도의 국가별 비교 연구 및 고찰)

  • Kim, Joo Hee;Yee, Jeong;Lee, Gwan Yung;Lee, Kyung Eun;Gwak, Hye Sun
    • Korean Journal of Clinical Pharmacy
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    • v.28 no.4
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    • pp.263-272
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    • 2018
  • Nonprescription drugs have become increasingly important in Korean healthcare. By leveraging lower-cost drugs and reducing expenditure associated with fewer physician visits, the nonprescription segment can deliver tremendous value to individual consumers and the Korean healthcare system. Many countries have provided simpler and more rapid routes to market entry for qualifying nonprescription drug products, using the established data on drug safety and efficacy, as well as public and professional opinion. In US, the FDA waived the pre-approval process for over-the-counter (OTC) drugs marketed through the OTC Monograph Process. In Australia and Canada, different OTC product application levels are defined, with a reduced level of assessment required when the risks to consumers are considered low. Japan established a new OTC evaluation system in 2014 to facilitate the Rx-to-OTC switch process. The legislative framework for medicinal products in the European Union allows for drugs to be approved with reference to appropriate bibliographic data for old active substances with well-established uses. Through a comparison of the regulatory framework and the requirements for nonprescription approval process in different countries, several ways to improve regulatory practice for the evaluation of nonprescription drugs in Korea have been suggested.

An Implementation of Realtime Remote-Monitoring System for Distributed Photovoltaic Power Plants (분산형 태양광 발전 시스템을 위한 실시간 원격 모니터링 시스템 구현)

  • Kim, Chang-Joon;Kim, Jung-Ki;Jang, Kyung-Sik
    • Journal of the Korea Institute of Information and Communication Engineering
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    • v.19 no.10
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    • pp.2450-2456
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    • 2015
  • In this paper, we propose a real-time remote monitoring system for distributed solar power generation system. The proposed system consists of PVC, UTC, OTC and monitoring server. PVC collects the operational information from the PV's inverter via serial interface. The sensing data is transmitted to the server by wireless communications and stored in the DB server. The PV's status is monitored via UTC, and the operating of PVC and UTC are managed by OTC. In addition, by providing information about the power generated by PV system and failure diagnosis in real time, the proposed system shows the possibility of reducing the maintenance costs and improved failure recovery time.