• Title/Summary/Keyword: FDA system development

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Development of Clean Water Supplying System for Greenhouse Cultivation and Convenience Water (I) - Development of the FDA System - (시설용수 및 영농편의용수 공급시스템 개발 (I) - FDA 시스템 개발 -)

  • Lee, Kwang-Ya;Choi, Kyung-Sook
    • Journal of The Korean Society of Agricultural Engineers
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    • v.51 no.5
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    • pp.95-100
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    • 2009
  • The water purification systems have been hardly used for agricultural purpose due to their complicated compositions and high costs for farmers, while only simple filtrations have been applied to irrigation systems in order to prevent the system from clogging problems. This study therefore developed a clean water supplying system, the Filter-Disinfection-Adsorption (FDA) system, especially for greenhouse cultivation of where low quality of water is available. This system has also been produced for providing convenience water to farmers in the areas of no water supply service systems for the purpose of washing their bodies or agricultural machineries after farm work. The FDA system consists of three stages of purification processes with an integral module, including disk and teflon filtrations and Ultraviolet (UV) sterilization processes. Indoor experiments were undertaken with a trial product of the FDA system to test its performance. The operation test of the process was performed as well as the condition check of each item including UV module, filters, control panel, pump, valves, etc. The results shows good performance of each test with no critical problems. The initial and maintenance costs were also analysed with other purification systems. From the comparisons, the FDA system found to be very economical and easy to use.

System Dynamics Modeling for FDA Regulation Effect of Pharmaceutical Industry (제약산업에서 FDA규제 영향에 관한 시스템 다이내믹스 모델링: FDA규제가 R&D비용에 미치는 영향을 중심으로)

  • Ko, Seong-Pil;Choi, Jeong-Hwan;Nam, Dong-Wok;Lee, Jeong-Dong
    • Korean System Dynamics Review
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    • v.13 no.4
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    • pp.57-80
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    • 2012
  • This research studies effect of FDA regulations in pharmaceutical industry on new drug development. System dynamics is implemented to demonstrate dynamic relationship between FDA regulations and R&D costs, firm's profits, sales. This research is focused on clinical trials of new medical entity process 50~60% portion of total development cost. Simulation results say that firm's profit is more sensitive to increasing the regulation than alleviating the regulation and effect of regulation policy make different result depending on the intensity of regulation and policy direction. Our simulation model provides the instrumental means for the policy makers and strategic decision in pharmaceutical industry.

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Effects of in Utero Exposure of Di(n-butyl)phthalate and Flutamide on the Development of Reproductive Organs in Male Rats

  • Shin, Jae-Ho;Lee, Su-Jung;Kim, Tae-Sung;Moon, Hyun-Ju;Kang, Il-Hyun;Kim, In-Young;Whang, Sung-Jo;Han, Soon-Young
    • Proceedings of the Korean Society of Toxicology Conference
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    • 2003.10b
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    • pp.181-181
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    • 2003
  • The aims of present study were to compare the effects of in utero exposure of several chemicals which have antiandrogenic characteristics on the development of reproductive organs and to investigate the specific mechanisms related to the abnormalities observed in the male reproductive system.(omitted)

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Development of Clean Water Supplying System for Greenhouse Cultivation and Convenience Water (II) - Assessment of the FDA System through a Site Application - (시설용수 및 영농편의용수 공급시스템 개발 (II) - FDA 시스템 현장적용성 평가 -)

  • Lee, Kwang-Ya;Choi, Kyung-Sook
    • Journal of The Korean Society of Agricultural Engineers
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    • v.51 no.5
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    • pp.101-106
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    • 2009
  • The previous study developed the Filter-Disinfection-Adsorption (FDA) system to provide clean irrigation water for greenhouse cultivation as well as convenience water to farmers. In this study, the field examination was undertaken to assess performance of the FDA system. The field application was made in the suburb of Daegu, one of the large city in Korea. The study area located near by down-stream of Gum-Ho river is suffering low irrigation water quality problems with no water supply service facilities. Four water quality parameters including Suspended Solid (SS), Biological Oxygen Demand (BOD), coliform, and turbidity were selected to test the purification performance of FDA system. Also in order to improve the system, this study investigated the defects of using the FDA system through field monitoring. As results, it was found that this system can be used to supply good quality of irrigation water for greenhouse cultivation and also provide convenience water to farmers in the field areas of no water supply services.

Studies on the development of removal technique of residual pesticides in ginseng concentration (인삼농축액의 잔류농약 제거기술 개발에 관한 연구)

  • Sin, Yeong-Min;Son, Yeong-Uk;Lee, Seon-Hwa;Jeong, Ji-Yoon;Won, Young-Jun;Lee, Chang-Hee;Kim, Woo-Seong;Chae, Kab-Ryong;Hong, Moo-Ki
    • The Korean Journal of Pesticide Science
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    • v.9 no.1
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    • pp.41-50
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    • 2005
  • For the removal of residual pesticides in ginseng extracts, we estabilished the removal process using pilot plant system, the characteristic components of ginseng maintains only. According to the agricultural chemical removal process, we monitored residual pesticides of 155 species, compraing the characteristic components of ginseng. The process of 4 types of agricultural chemical removal process compared to the control test was appeared that the residual pesticides were eliminated. As results above, the most efficient method of the possibility of raising the removal ratio of the agricultural chemical construction process was dried process of hexane after dipping and also remaining quality of the hexane appeared lowly. Besides, the removal process had an effected on the ginsenocide os ginseng, only the residual pesticides will be able to remove.

Design of a Tracking & Recall Management System for Implantable Devices (이식형 의료기기의 추적 및 회수 관리를 위한 통합전산관리시스템 설계)

  • Park, Soon-Mahn;Yoo, Sun-Kook
    • Journal of the Institute of Electronics Engineers of Korea SC
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    • v.48 no.5
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    • pp.74-80
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    • 2011
  • Medical implant devices are one of the targets of the US's Food & Drug Administration (FDA) for tracking in case of a serious adverse event since they are directly connected to the lives of patients. The US law stipulates that the public health agency shall order implantable device makers to track their product down to the patient level if a serious adverse event has occurred or defects have been discovered; in reality, however, the agency can pass on the responsibility for tracking or recalling faulty devices to the manufacturers or use mass media. This article proposes an efficient tracking and recall management system and examines four main virtual scenarios based on such. This research seeks to suggest a system that enables FDA to perform accurate and prompt tracking and recall management for patients' enhanced safety.

Development and validation of analytical methods for pyrifluquinazon residues determination on agricultural commodities by HPLC-UVD (HPLC-UVD를 이용한 농산물 중 pyrifluquinazon 잔류시험법 개발 및 검증)

  • Do, Jung-Ah;Kwon, Ji-Eun;Kim, Mi-Ra;Lee, Eun-Mi;Kuk, Ju-Hee;Cho, Yoon-Jae;Chang, Moon-Ik;Kwon, Kisung;Oh, Jae-Ho
    • Analytical Science and Technology
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    • v.26 no.3
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    • pp.174-181
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    • 2013
  • Pyrifluquinazon is classified with a quinazoline insecticide that regulates food intake by controling the feeding behavior acting on the endocrine or nervous system of pests such as aphids and white fly. To keep safety on pyrifluquinazon residues in agricultural commodities a simple, accurate and rapid analytical method was developed and validated using high performance liquid chromatograph (HPLC-UVD). The pyrifluquinazon residues acidified with 1% formic acid in samples were extracted with acetonitrile and partitioned with hexane subsequently to dichloromethane then purified with silica solid phase extraction (SPE) cartridge. The purified samples were detected using HPLC-UVD. The method was validated using apple and pear spiked with pyrifluquinazon at 0.02, 0.05 and 0.1 mg/kg and hulled rice, pepper, soybean at 0.05 and 0.1 mg/kg. Average recoveries were 70.5~107.9% with relative standard deviation less than 10%. The result of recoveries and overall coefficient of variation of a laboratory results in Gwangju regional FDA and Daejeon regional FDA was followed with Codex guideline (CODEX CAC/GL 40). This method is appropriated at pyrifluquinazon residues determination and will be used as official method of analysis.

Application of Molecular Diagnostics Technology in the Development of a Companion Diagnostics for Malignant Solid Tumors (악성 고형암의 항암제 동반진단 기술에서 분자진단기술의 적용)

  • Kim, Jin-Hee
    • The Journal of the Korea Contents Association
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    • v.19 no.3
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    • pp.365-374
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    • 2019
  • Unlike benign tumors, malignant tumors are capable of metastasis, easy to relapse, poor survival, and low quality of life. In Korea, here is a tendency to treat the tumors collectively according to the General Principles of Cancer Chemotherapy(GPCC) of the Health Insurance Review & Assessment Service (HIRA). But recently, companion diagnostics(CDx) is recommended rather than unilateral medication because biomarker-based molecular diagnostics is possible to predict the drug response of patients before drug treatment. Not only domestic but also overseas Food and Drug Administratio (FDA) recommends the development of the CDx system at the stage of drug development to ensure the responsiveness and safety of medicines. In this study, I focused on the necessity of CDx development direction as well as CDx development status through literature review. Furthermore I also discussed CDx types according to the molecular diagnostic technology such as immunohistochemistry (IHC), polymerase chain reaction (PCR), in situ hybridization (ISH), and next-generation sequencing (NGS) not only in the approved CDx but also in the developing one by US FDA. And I suggested the technology issue of CDx development process such as a selection of molecular diagnostics at the time of release, a clear understanding of the CDx mechanism, and a convergence of drug with CDx development. The necessity of social insurance system also was proposed for CDx development.

A Case Study of National Food Safety Control System Assessment in the U.S. (미국의 국가식품안전관리체계 평가 사례연구)

  • Lee, Heejung
    • Journal of Food Hygiene and Safety
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    • v.32 no.3
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    • pp.179-186
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    • 2017
  • For more efficient and proactive safety control of imported food, new trend in U.S. is emerging, which assesses the food safety control systems of exporting countries using Systems Recognition Assessment Tool and helps ensure safety of imported foods. This study examines trends in development and application of assessmemnt tool and country assessment reports in U.S. where an active discussion on this issue is in progress. The expert interviews were also conducted. U.S. Systems Recognition Assessment Tool was developed by FDA to recognize the potential value in leveraging the expertise of foreign food safety systems and help ensure safety of imported food. The tool is comprised of ten standards and provides an objective framework for determining the robustness of trading partners' overall food safety systems. Using its own tool, the U.S. FDA conducted a preliminary assessment of the food safety control systems of New Zealand and Canada. According to the U.S.-New Zealand and the U.S.-Canada assessment reports, the overall structure of the systems was similar between the countries. In summarizing the opinions of experts, such a trend in National Food Safety Control System Assessment may be utilized in the sanitary assessment and the control of imported food border inspection frequency before importing food. It would contribute to more effective distribution of national budget and increased public trust. Additionally, international collaboration as well as securing of qualified experts and sufficient budget appear to be crucial to further increase the utility of National Food Safety Control Systems Assessment. In conclusion, firstly, it is critically important for the competent authority of South Korea to proactively respond to international trend in National Food Safety Control System Assessment by identifying the details of its background, assessment purpose, core assessment elements, and assessment procedures. Secondly, it is necessary to identify and complement the weaknesses of Korea's food safety control system by reviewing it with U.S. Systems Recognition Assessment Tool. Thirdly, by adapting the assessment results from imported countries' food safety control systems to the imported food inspection intensity, the resources previously used in inspecting the imported food from accredited countries can be redistributed to inspecting the imported food from unaccredited countries, and it would contribute to more efficient imported food safety control. Fourthly, the competent authority of South Korea should also consider developing its own assessment tool designed to reflect the unique characteristics of its food safety control system and international guidelines.

Development of A New Herbal Composition HemoHIM as An Immune-Improving Agent Using Irradiated Animal Models (방사선조사 동물모델 이용 면역기능개선-생약복합물 헤모힘(HemoHIM)개발)

  • Jo, Seong-Gi
    • Radioisotope journal
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    • v.21 no.4
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    • pp.38-45
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    • 2006
  • A new herbal composition. HemoHIM, was developed using irradiated animal models and was successfully applied as an immune-improving agent. In a view that the protection and recovery of immune, hematopoietic and self-renewal tissues are essential for radioprotective agents, HemoHIM was developed based on a novel combination of three edible herbs (Angelica Radix, Cnidii Rhizoma. Paeonin Radix) that meet all those requirements. HemoHIM significantly protected the immune and hematopoietic system and enhanced their recovery in y-irradiated mice. For the application of HemoHIM as a health functional food and a supplementary agent for the cancer patients, the efficacy of HemoHIM to improve the immune functions was further evaluated in immune-depressed animals and humans. Animal studies demonstrated that HemoHIM significantly improved the immune functions in cyclophosphamide-treated mice, aged mice, and dexamethasone-treated mice. In human studies, HemoHIM enhanced the immune activity and cytokine secretion in sub-healthy volunteers, and alleviated the severe leukocyre depression in cancer patients during radiation and chemotherapy. Based on these results, HemoHIM was approved by Korea FDA as a material of health functional food for immune function improvement and will be commercially available soon. This case of HemoHIM research and development suggested that irradiated animals can be good models for biological degenerations such as immune depression, self-renewal tissue damage, and aging for the development of biological modulators.

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