• Title/Summary/Keyword: Study guideline Development

Search Result 1,136, Processing Time 0.035 seconds

Development of Aceclofenac Soft Capsule (Clanza S Soft Capsule) (아세클로페낙 연질캡슐(클란자 에스 연질캡슐)의 개발)

  • Yong, Chul-Soon;Lee, Kyung-Hee;Choi, Jin-Suck;Park, Byung-Joo;Jung, Se-Hyun;Kim, Yong-Il;Park, Sang-Man;Bae, Myung-Soo;Kim, Gui-Ja;Gill, Young-Sig;Yu, Chang-Hun;Kang, Sung-Lyoung;Yoo, Bong-Kyu;Rhee, Jong-Dal;Choi, Han-Gon
    • Journal of Pharmaceutical Investigation
    • /
    • v.34 no.1
    • /
    • pp.49-55
    • /
    • 2004
  • To develop a aceclofenac soft capsule, four preparations with various solubilizers were prepared and their dissolution test was carried out. Among four preparations tested, a preparation with ethanolamine was selected as a formula of aceclofenac soft capsule (Clanza $S^{TM}$), since it showed the fastεst dissolution rate. Bioequivalence of aceclofenac tablet, $Airtal^{TM}$ (Dae-Woong Pharmaceutical Co., Ltd.) and aceclofenac soft capsule, Clanza $S^{TM}$ (Korea United Pharmaceutical Co., Ltd.) was evaluated according to the guideline of KA Fourteen normal male volunteers (age 20 - 25 years old) were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After oral administration of one tablet or capsule containing 100 mg of aceclofenac, blood was taken at predetermined time intervals and the concentration of aceclofenac in plasma was determined with an HPLC method under UV detector The pharmacokinetic parameters ($C_{max}$ and $AUC_t$) were calculated and ANOVA was utilized for the statistical analysis of parameters using logarithmetically transformed $AUC_t$, $C_{max}$ and $T_{max}$. The results showed that the differences in $AUC_t$, $C_{max}$ and $T_{max}$ between Aral tablet and Clanza soft capsule were 2.89%, 0.18% and 43.0%, respectively. There were no sequence effects between two formulations in these parameters. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of log(0.8) to log(15) (e.g. log(0.81) -log(1.23) ad log(0.89) -log(1.4)) fo $AUC_t$ and $C_{max}$, respectively. Thus, the criteria of the KFDA guidelines for the equivalence was satisfied, indicating that Clanza $S^{TM}$ soft capsule is bioequivalent to$Airtal^{TM}$ tablet.

Rewetting Strategies for the Drained Tropical Peatlands in Indonesia (인도네시아의 배수된 열대 이탄지에 대한 재습지화 전략)

  • Roh, Yujin;Kim, Seongjun;Han, Seung Hyun;Lee, Jongyeol;Son, Yowhan
    • Korean Journal of Environmental Biology
    • /
    • v.36 no.1
    • /
    • pp.33-42
    • /
    • 2018
  • The tropical peatlands have been deforested and converted to agricultural and plantation areas in Indonesia. To manage water levels and increase the overall productivity of crops, canals have been constructed in tropical peatlands. The canals destructed the structure of the tropical peatlands, and increased the subsidence and fire hazard risks in the region. The Indonesian government enacted regulations and a moratorium on tropical peatlands, in order to reduce degradation. A practical method under the regulations of rewetting tropical peatlands was to permit a canal blocking. In this study, four canal blocking projects were investigated regarding their planning, construction priority, design, building material, construction, monitoring, time and costs associated with the canal blockings. In the protected areas, regulations restricted the development of the tropical peatlands areas that were noted as deeper than 3 m, and the administration stopped issuing new concessions for future work projects for this noted criteria of land use. A noted purpose of canal blockings in these areas was to effectuate the restoration of the lands in the region. The main considerations of the restoration efforts were to maintain a durability of the blockings, and to encourage the participation of the area stakeholders. In the case of a concession area, regulations were set into place to restrict clear-cutting and shifting cultivation, and to maintain groundwater level in the tropical peatland. The most significant priorities identified in the canal blocking project were the efficiency and cost-effectiveness of the project. Nevertheless, the drainage of tropical peatlands has been continued. On the basis of a literature review on regulations and rewetting methods in tropical peatlands of Indonesia, we discussed the improvements of the regulations, and adequate canal blockings to serve the function to rewet the tropical peatlands in Indonesia. Our results would help establishing an adequate direction and recommended guideline on viable rewetting methods for the restoration of drained tropical peatlands in Southeast Asia.

Development of Simultaneous Analytical Method for Determination of Isoxaflutole and its Metabolite (Diketonitrile) residues in Agricultural Commodities Using LC-MS/MS (LC-MS/MS를 이용한 농산물 중 Isoxaflutole과 대사산물(Diketonitrile)의 동시시험법 개발)

  • Ko, Ah-Young;Kim, Heejung;Do, Jung Ah;Jang, Jin;Lee, Eun-Hyang;Ju, Yunji;Kim, Ji Young;Chang, Moon-Ik;Rhee, Gyu-Seek
    • The Korean Journal of Pesticide Science
    • /
    • v.20 no.2
    • /
    • pp.93-103
    • /
    • 2016
  • A simultaneous analytical method was developed for the determination of isoxaflutole and metabolite (diketonitrile) in agricultural commodities. Samples were extracted with 0.1% acetic acid in water/acetonitrile (2/8, v/v) and partitioned with dichloromethane to remove the interference obtained from sample extracts, adjusting pH to 2 by 1 N hydrochloric acid. The analytes were quantified and confirmed via liquid chromatograph-tandem mass spectrometer (LC-MS/MS) in positive-ion mode using multiple reaction monitoring (MRM). Matrix matched calibration curves were linear over the calibration ranges ($0.02-2.0{\mu}g/mL$) for all the analytes into blank extract with $r^2$ > 0.997. For validation purposes, recovery studies were carried out at three different concentration levels (LOQ, 10LOQ, and 50LOQ) performing five replicates at each level. The recoveries were ranged between 72.9 to 107.3%, with relative standard deviations (RSDs) less than 10% for all analytes. All values were consistent with the criteria ranges requested in the Codex guideline (CAC/GL40, 2003). Furthermore, inter-laboratory study was conducted to validate the method. The proposed analytical method was accurate, effective, and sensitive for isoxaflutole and diketonitrile determination in agricultural commodities.

Optimization of Processing Process for Functional Anchovy Fish Sauce in Addition with Raw Sea Tangle (다시마를 첨가한 기능성 멸치액젓 제조조건 확립)

  • Jeong, Min-Hong;Jeong, Woo-Young;Gyu, Hyeon-Jin;Jeong, Sang-Won;Park, Hun-Kyu;Cho, Young-Je;Shim, Kil-Bo
    • Journal of Fisheries and Marine Sciences Education
    • /
    • v.25 no.6
    • /
    • pp.1408-1418
    • /
    • 2013
  • To investigate the quality properties of functional anchovy fish sauce added with raw sea tangle, 2%, 5%, and 10% (w/w) of sea tangle was added to 25% (w/w) salted anchovy and then fermented at $20^{\circ}C$. During fermentation period, the amino nitrogen contents were increased at all groups and the highest contents were at 450 days of fermentation with $11.99{\pm}0.08$, $12.51{\pm}0.08$, and $11.95{\pm}0.08mg/mL$ at 2%, 5%, and 10% addition of raw sea tangle, respectively. After later, the contents were keeping at a similar level. VBN contents were continuously increased until 270 days of fermentation with $208.10{\pm}3.50$, $210.00{\pm}4.10$, $215.15{\pm}1.50mg/100ml$ at 2%, 5%, 10% addition of raw sea tangle, respectively. Alginic acid recovery was gradually increased in fermentation duration, showed the highest concentration at 540 days of fermentation with 67.00, 67.25, 67.90% at 2%, 5% and 10% addition of raw sea tangle, respectively. Dietary fiber recovery was rapidly increased at the beginning of fermentation and then decreased slowly as the fermentation is progressed. The highest recovery was at 30 days with 18.7, 18.6, and 17.9%, and the lowest was at 360 days with 8.7 and 11.1% at 2 and 10% addition of raw sea tangle, respectively, and 450 days with 11.4% at 5% sea tangle. The lowest fucoidan contents were exhibited at 30 days of fermentation with 0.07% at both of 2% and 5% addition, and 90 days with 0.10% at 10% addtion of sea tangle. The highest fucoidan contents were 270 days showing 0.24, 0.25, and 0.23% at 2, 5, and 10% addition, respectively. All groups adding different sea tangle concentration were not significantly different at all properties. However, the newly developed products were sufficient to the standard guideline of Korea Food Drug Adminstration. The best processing process of functional anchovy fish sauce in addition with raw sea tangle is 2% addition of raw sea tangle and fermented more than 450 days. The results obtained in this study indicated that the fish sauce added with sea tangle is superior in taste, functions to traditional fish sauce and could be competitive fishery fermented food.

Performance Evaluation of Advance Warning System for Transporting Hazardous Materials (위험물 운송을 위한 조기경보시스뎀 성능평가)

  • Oh Sei-Chang;Cho Yong-Sung
    • The Journal of The Korea Institute of Intelligent Transport Systems
    • /
    • v.4 no.1 s.6
    • /
    • pp.15-29
    • /
    • 2005
  • Truck Shipment Safety Information, which is a part of the development of NERIS is divided into Optimal Route Guidance System and Emergency Response System. This research is for establishing an advance warning system, which aims for preventing damages(fire, explosion, gas-escape etc.) and detecting incidents that are able to happen during transporting hazardous materials in advance through monitoring the position of moving vehicles and the state of hazardous materials in real-time. This research is peformed to confirm the practical possibility of application of the advance warning system that monitors whether the hazardous materials transport vehicles move the allowed routes, finds the time and the location of incidents of the vehicles promptly and develops the emergency system that is able to respond to the incidents as well by using the technologies of CPS, CDMA and CIS with testing the ability of performance. As the results of the test, communication accuracies are 99$\%$ in freeway, 96$\%$ in arterial, 97$\%$ in hilly sections, 99$\%$ in normal sections, 96$\%$ in local sections, 99$\%$ in urban sections and 98$\%$ in tunnels. According to those results, the system has been recorded a high success rate of communication that enough to apply to the real site. However, the weak point appeared through the testing is that the system has a limitation of communication that is caused in the rural areas and certain areas where are fewer antennas that make communication possible between on-board unit and management server. Consequently, for the practical use of this system, it is essential to develop the exclusive en-board unit for the vehicles and find the method that supplements the receiving limitation of the GPS coordinates inside tunnels. Additionally, this system can be used to regulate illegal acts automatically such as illegal negligence of hazardous materials. And the system can be applied to the study about an application scheme as a guideline for transporting hazardous materials because there is no certain management system and act of toxic substances in Korea.

  • PDF

GIS-based Market Analysis and Sales Management System : The Case of a Telecommunication Company (시장분석 및 영업관리 역량 강화를 위한 통신사의 GIS 적용 사례)

  • Chang, Nam-Sik
    • Journal of Intelligence and Information Systems
    • /
    • v.17 no.2
    • /
    • pp.61-75
    • /
    • 2011
  • A Geographic Information System(GIS) is a system that captures, stores, analyzes, manages and presents data with reference to geographic location data. In the later 1990s and earlier 2000s it was limitedly used in government sectors such as public utility management, urban planning, landscape architecture, and environmental contamination control. However, a growing number of open-source packages running on a range of operating systems enabled many private enterprises to explore the concept of viewing GIS-based sales and customer data over their own computer monitors. K telecommunication company has dominated the Korean telecommunication market by providing diverse services, such as high-speed internet, PSTN(Public Switched Telephone Network), VOLP (Voice Over Internet Protocol), and IPTV(Internet Protocol Television). Even though the telecommunication market in Korea is huge, the competition between major services providers is growing more fierce than ever before. Service providers struggled to acquire as many new customers as possible, attempted to cross sell more products to their regular customers, and made more efforts on retaining the best customers by offering unprecedented benefits. Most service providers including K telecommunication company tried to adopt the concept of customer relationship management(CRM), and analyze customer's demographic and transactional data statistically in order to understand their customer's behavior. However, managing customer information has still remained at the basic level, and the quality and the quantity of customer data were not enough not only to understand the customers but also to design a strategy for marketing and sales. For example, the currently used 3,074 legal regional divisions, which are originally defined by the government, were too broad to calculate sub-regional customer's service subscription and cancellation ratio. Additional external data such as house size, house price, and household demographics are also needed to measure sales potential. Furthermore, making tables and reports were time consuming and they were insufficient to make a clear judgment about the market situation. In 2009, this company needed a dramatic shift in the way marketing and sales activities, and finally developed a dedicated GIS_based market analysis and sales management system. This system made huge improvement in the efficiency with which the company was able to manage and organize all customer and sales related information, and access to those information easily and visually. After the GIS information system was developed, and applied to marketing and sales activities at the corporate level, the company was reported to increase sales and market share substantially. This was due to the fact that by analyzing past market and sales initiatives, creating sales potential, and targeting key markets, the system could make suggestions and enable the company to focus its resources on the demographics most likely to respond to the promotion. This paper reviews subjective and unclear marketing and sales activities that K telecommunication company operated, and introduces the whole process of developing the GIS information system. The process consists of the following 5 modules : (1) Customer profile cleansing and standardization, (2) Internal/External DB enrichment, (3) Segmentation of 3,074 legal regions into 46,590 sub_regions called blocks, (4) GIS data mart design, and (5) GIS system construction. The objective of this case study is to emphasize the need of GIS system and how it works in the private enterprises by reviewing the development process of the K company's market analysis and sales management system. We hope that this paper suggest valuable guideline to companies that consider introducing or constructing a GIS information system.

Nomenclature of the Seas Around the Korean Peninsula Derived From Analyses of Papers in Two Representative Korean Ocean and Fisheries Science Journals: Present Status and Future (국내 대표 해양·수산 과학논문 분석을 통한 우리나라 주변 바다 이름표기에 대한 제언)

  • BYUN, DO-SEONG;CHOI, BYOUNG-JU
    • The Sea:JOURNAL OF THE KOREAN SOCIETY OF OCEANOGRAPHY
    • /
    • v.23 no.3
    • /
    • pp.125-151
    • /
    • 2018
  • We grouped the names attributed to the seas surrounding the Korean Peninsula in maps published in two major Korean ocean and fisheries science journals over the period from 1998 to 2017: the Journal of the Korean Society of Oceanography (The Sea) and the Korean Journal of Fisheries and Aquatic Science (KFAS). The names attributed to these seas in maps of journal paper broadly were classified into three groupings: (1) East Sea and Yellow Sea; (2) East Sea, Yellow Sea, and South Sea; or (3) East Sea, West Sea and South Sea. The name 'East Sea' was dominantly used for the waters between Korea and Japan. In contrast, the water between Korea and China has been mostly labelled as 'Yellow Sea' but sometimes labelled as 'West Sea'. The waters between the south coast of Korea and Kyushu, Japan were labelled as either 'Korea Strait' or 'South Sea'. This analysis on sea names in the maps of 'The Sea' and 'KFAS' reveals that domestic researchers frequently mix geographical and international names when referring to the waters surrounding the Korean Peninsula. These inconsistencies provide the motivation for the development of a basic unifying guideline for naming the seas surrounding the Korean Peninsula. With respect to this, we recommend the use of separate names for the marginal seas between continental landmasses and/or islands versus for the coastal waters surrounding Korea. For the marginal seas, the internationally recognized names are recommended to be used: East Sea; Yellow Sea; Korea Strait; and East China Sea. While for coastal seas, including Korea's territorial sea, the following geographical nomenclature is suggested to differentiate them from the marginal sea names: Coastal Sea off the East Coast of Korea (or the East Korea Coastal Zone), Coastal Sea off the South Coast of Korea (or the South Coastal Zone of Korea), and Coastal Sea off the West Coast of Korea (or the West Korea Coastal Zone). Further, for small or specific study areas, the local region names, district names, the sea names and the undersea feature names can be used on the maps.

Development and Validation of an Analytical Method for Ametoctradin Residue Determination in Domestic Agricultural Commodities by HPLC-PDA (HPLC-PDA를 이용한 국내 유통 농산물 중 ametoctradin 잔류량 분석법 개발 및 검증)

  • Do, Jung-Ah;Kwon, Ji-Eun;Lee, Eun-Mi;Kim, Mi-Ra;Kuk, Ju-Hee;Cho, Yoon-Jae;Kang, Il-Hyun;Kim, Hyung-Su;Kwon, Kisung;Oh, Jae-Ho
    • Korean Journal of Food Science and Technology
    • /
    • v.45 no.3
    • /
    • pp.285-292
    • /
    • 2013
  • This study was carried out to validate the safety of ametoctradin residues in agricultural commodities by developing an official analysis method. An analytical method was developed and validated using HPLC-PDA detectors. The samples were extracted with methanol, subsequently partitioned with dichloromethane and purified with florisil column chromatograph using acetone/hexane (30/70, v/v) as solvent. The method was validated by using grape, hulled rice, mandarin, and potato spiked with ametoctradin at 0.05 and 5.0 mg/kg, and pepper at 0.05 and 2.0 mg/kg. Average recoveries were 76-114.8% with relative standard deviation less than 10%, and the limit of detection and limit of quantification were 0.0125 and 0.05 mg/kg, respectively. The result of recoveries and overall coefficient of variation of the laboratory results from Gwangju regional Food and Drug Administration (FDA) and Daejeon regional FDA was accorded with Codex Alimentarius Commission Guideline (CAC/GL 40). Based on these results, this method was found to be appropriate for ametoctradin residue determination and can be used as the official method of analysis.

Development of a Mobile Application for Promoting Risk Communication on Food Additives Based on the Information Needs of Parents (학부모의 정보요구도에 기초한 식품첨가물 위해정보전달 스마트폰 애플리케이션의 개발)

  • Kim, Suna;Kim, Ye jee;Kim, Ji-Sun;Kim, Jeong-Weon
    • Journal of Food Hygiene and Safety
    • /
    • v.30 no.2
    • /
    • pp.132-142
    • /
    • 2015
  • The purpose of this study was to investigate the perception and information needs about food additives from the parents of elementary school children, and to develop a smartphone application (App) providing information about food additives, and finally to assess its educational effects. A survey was conducted in April 2013 by using a self-administered questionnaire, and total 358 responses were collected from the parents living in Seoul and Gyeonggi province. While purchasing processed foods, parents considered safety (40.5%) as the most important factor, and first checking item except production and expiration dates was origin labelling (35.4%), and chose foods with less food additives (63.1%). Parents recognized food additives as the most dangerous (42.7%), and 75.1% responded the level of danger as 'very dangerous'. However, 82.4% of parents didn't have experiences to get educations about food additives. Based on their information needs including the safety, legal standards and the foods containing food additives. a smartphone App designated as 'Catch up Food Additives' consisting of the definition, safety, food labelling guideline, management, animation about food additives was developed. When the App was exposed to the parents (n = 27), their negative perceptions on food additives were improved significantly. These results showed that providing information and education about food additives using smartphone App was very fast and effective for the promotion of risk communication on food additives with the parents.

Development and Validation of the Determination of Sorafenib in Human Plasma using Tandem Mass Spectrometry Coupled with Liquid Chromatography (고속액체크로마토그래피 텐덤질량분석기법을 이용한 사람 혈장 내 소라페닙 농도분석법의 개발 및 검정)

  • Park, Daejin;Lee, Sunggon;Kim, Woomi
    • Journal of Life Science
    • /
    • v.22 no.11
    • /
    • pp.1456-1462
    • /
    • 2012
  • Sorafenib is a multikinase inhibitor and an oral anticancer drug approved for the treatment of patients with advanced renal cell carcinoma and those with unresectable hepatocellular carcinoma. The purpose of this study was to develop an efficient method of the determination of sorafenib in human plasma using tandem mass spectrometry coupled with liquid chromatography (LC/MS/MS) and validate the method by the guidelines of the Korean Food and Drug Administration (KFDA). Plasma samples ($100{\mu}l$) were added with chlorantraniliprole as an internal standard and then mixed with the 0.1% formic acid-containing extraction solution composed of isopropyl alcohol and ethyl acetate (1:4, v/v). After centrifugation, the supernatant was concentrated at $45^{\circ}C$ under negative pressure and centrifugal force. The residue was reconstituted with a mobile phase and injected into the HPLC instrument using a reverse phase Waters XTerra$^{TM}$ C18 column (particle size $3.5{\mu}m$). Liquid chromatography was carried out within the run time of 5 min using a mobile phase composed of buffer (0.1% formic acid and 10 mM ammonium formate), methanol, and acetonitrile (1:6:3, v/v/v). The analytes were monitored by tandem mass spectrometry in the multiple reaction monitoring method programmed to detect sorafenib at 'm/z 465.2 ${\rightarrow}$ 252.5' and chlorantraniliprole at 'm/z 484.4 ${\rightarrow}$ 286.2' with positive electrospray ionization mode ($ES^+$). The result showed the proper linearity ($r^2$ > 0.99) over the range of 2,000-5,000 ng/ml with good accuracy (90.7-103.9%) and precision (less than 10%). The newly developed method using LC/MS/MS was validated by the guideline of KFDA and identified as more sensitive compared to the previous methods.