• Title/Summary/Keyword: Evaluation and Standardization

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An Evaluation of the Standardization of Records Management (준현용 기록관리 표준화의 평가)

  • Seol, Moon-Won
    • Journal of the Korean Society for Library and Information Science
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    • v.43 no.3
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    • pp.355-377
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    • 2009
  • In 2005, the National Archives of Korea (NAK) set up the Records Management Standards Plan in the process of public records management innovation and released 55 standards and guidelines based on this plan. This study is to evaluate the standardization for records management so far with a critical view and suggest implications for rebuilding standardization strategies. For evaluation, it analyses records management standardization policies and the status of standard development through NAK's standardization policy documents and interviews records managers in central government agencies via e-mail. The categories of evaluation are the selection for the standardization areas, the quality of standard content, the standardization procedures, and the policies for sustainable standardization. It evaluates qualitatively with criteria set up in each category and then suggests some recommendations for the improvement of records management standardization.

Comparative Study of the Korean Pharmacopoeia with North Korean Pharmacopoeia (남.북한 약전에 대한 비교조사연구)

  • Choi, Myoeng-Sin;Kang, Chan-Soon;Kim, Hye-Soo;Kim, Eun-Jung;Hong, Chong-Hui;Ko, Yong-Seok;Kim, Sang-Hyun;Jang, Sung-Jae
    • Journal of Pharmaceutical Investigation
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    • v.34 no.5
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    • pp.427-433
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    • 2004
  • With the Sunshine policy, exchange of materials and cultures inter Koreas has been broadened and expectancy of reunification is getting higher. Especially, medical supplies and medicines are one of the biggest parts in the exchange goods. So, preparing an unified official drug standard preparing new medical administration system is required. We compared the Korean pharmacopoeia with North Korean Pharmacopoeia. Two pharmacopoeias have been developed in different direction and have many differences in the nomenclature and format. In this study, we compared general notices, general rules for preparations and crude drugs, monographs, general tests, processes and apparatus.

Cardioprotective effect of ginsenoside Rb1 via regulating metabolomics profiling and AMP-activated protein kinase-dependent mitophagy

  • Hu, Jingui;Zhang, Ling;Fu, Fei;Lai, Qiong;Zhang, Lu;Liu, Tao;Yu, Boyang;Kou, Junping;Li, Fang
    • Journal of Ginseng Research
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    • v.46 no.2
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    • pp.255-265
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    • 2022
  • Background: Ginsenoside Rb1, a bioactive component isolated from the Panax ginseng, acts as a remedy to prevent myocardial injury. However, it is obscure whether the cardioprotective functions of Rb1 are related to the regulation of endogenous metabolites, and its potential molecular mechanism still needs further clarification, especially from a comprehensive metabolomics profiling perspective. Methods: The mice model of acute myocardial ischemia (AMI) and oxygen glucose deprivation (OGD)-induced cardiomyocytes injury were applied to explore the protective effect and mechanism of Rb1. Meanwhile, the comprehensive metabolomics profiling was conducted by high-performance liquid chromatography and quadrupole time-of-flight mass spectrometry (HPLC-Q/TOF-MS) and a tandem liquid chromatography and mass spectrometry (LC-MS). Results: Rb1 treatment profoundly reduced the infarct size and attenuated myocardial injury. The metabolic network map of 65 differential endogenous metabolites was constructed and provided a new inspiration for the treatment of AMI by Rb1, which was mainly associated with mitophagy. In vivo and in vitro experiments, Rb1 was found to improve mitochondrial morphology, mitochondrial function and promote mitophagy. Interestingly, the mitophagy inhibitor partly attenuated the cardioprotective effect of Rb1. Additionally, Rb1 markedly facilitated the phosphorylation of AMP-activated protein kinase α (AMPKα), and AMPK inhibition partially weakened the role of Rb1 in promoting mitophagy. Conclusions: Ginsenoside Rb1 protects acute myocardial ischemia injury through promoting mitophagy via AMPKα phosphorylation, which might lay the foundation for the further application of Rb1 in cardiovascular diseases.

Tests for Volume of Injections in Containers (주사제의 실용량시험법에 관한 조사)

  • Choi, Myung-Hee;Park, Seung-Hee;Choi, Bo-Kyung;Kang, Chan-Soon;Lee, Suk-Ho;Kim, Kil-Soo
    • Journal of Pharmaceutical Investigation
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    • v.30 no.3
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    • pp.223-228
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    • 2000
  • Testing the volume of injection in container is to ensure that the nominal content of a container can be administered to the patient. The method to test the volume of injection in container is described in European Pharmacopeia (EP) and United States Pharmacopeia (USP). However there is no method to test the volume of injection in Korean Pharmacopeia (KP). So we surveyed the method practiced by 53 pharmaceutical companies in Korea by a questionnaire and tested commercially available injections by discharged volume. As the result, we agreed with the International Conference on Harmonization (ICH) test method for discharged volume. It was suggested that the ICH test method for discharged volume of injection in container would be adopted.

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The Quality Regulation of Drug Excipients (의약품첨가물과 규격관리)

  • Choi, Myoeng-Sin;Hong, Chong-Hui;Jang, Seung-Jae;Kang, Chan-Soon
    • Journal of Pharmaceutical Investigation
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    • v.33 no.1
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    • pp.67-71
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    • 2003
  • Drug excipients are material used in the formulation of pharmacologically active drugs. They have a variety of roles including dilutents/fillers/bulking agents, binders/adhesives, propellant, disintegrants, lubricants/dlidants, colors, flavors, coating agents, polising agents, fragrance, sweeteening agent, polymers and waxes. Excipient should be inert or inactive and does not interfere with the test. Nowadays within industry there has been a recent surge of interest in novel excipient for novel dosage forms. The purpose of the review is to introduce the administration systems of drug excipient about kinds, matters to be attended to change of excipients.

Strategic Development Plan of Standardization on Korean Medicine : Comparison with Traditional Medicine Policies between Korea and China (한의약 표준화 발전방안 연구: 한-중 전통의학 표준화 정책비교를 바탕으로)

  • Lee, Juyeon;Lee, Minho;Choi, Sun-mi;Kim, Yong-suk;Koh, Byunghee;Moon, Jinseok
    • The Journal of Korean Medicine
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    • v.37 no.3
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    • pp.97-111
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    • 2016
  • Objectives: This study aims to investigate the policy status of traditional medicine standardization between Korea and China as well as to derive a strategic development plan for Korean medicine standardization. Methods: The existing national plans and preceding studies on traditional medicine standardization in Korea and China were reviewed, and scope of the study was categorized as having three main aspects: infrastructure; standard development and standardization activities; and application and diffusion. Results: Nine development plans for Korean medicine standardization derived under the study were as follows: With regard to infrastructure of standardization, 1) standardization plan of Korean medicine shall be established based on involvement of multi-government ministries. 2) It shall be set with a consistent cooperation process among standardization-related organizations, as well as 3) encourage the industry to participate in standardization activities. To activate standards development, 4) launching the R&D-standardization-industrialization linked project, 5) supporting Korean medicine society and the mirror committee for motivation, and 6) planning the international joint research for development of standard and expanding standardization activities are recommended. In the aspect of application, there is a need for 7) expanding certification systems for the industry and 8) evaluation and feedback on the life-cycle of standardization. Lastly, 9) educational programs for training experts of standardization shall be developed and implemented. Conclusions: In order to invigorate standardization activities for Korean medicine, enhancement of planning and evaluation capacity, ensuring the strategic development of standards, broadening boundaries of international standardization activities, and training professionals are required.

A Study on Test ST Evaluation Standardization of Biometrics Industry (생체인식 산업의 시험평가부문 표준화에 관한 연구)

  • 강병노;송수정
    • Proceedings of the Safety Management and Science Conference
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    • 2003.05a
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    • pp.115-120
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    • 2003
  • The purpose of this study is to carry out comparative analysis of the differences between the trend of biometrics-related test St evaluation standardization in the world and that of Korea, and to suggest ideal directions and building plans for domestic biometrics industry. Its purpose also includes constructing promptly a standardization of domestics biometrics industry based on the suggested standards.

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Chemical transformation and target preparation of saponins in stems and leaves of Panax notoginseng

  • Wang, Ru-Feng;Li, Juan;Hu, Hai-Jun;Li, Jia;Yang, Ying-Bo;Yang, Li;Wang, Zheng-Tao
    • Journal of Ginseng Research
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    • v.42 no.3
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    • pp.270-276
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    • 2018
  • Background: Notoginsenoside Ft1 is a promising potential candidate for cardiovascular and cancer disease therapy owing to its positive pharmacological activities. However, the yield of Ft1 is ultralow utilizing reported methods. Herein, an acid hydrolyzing strategy was implemented in the acquirement of rare notoginsenoside Ft1. Methods: Chemical profiles were identified by ultraperformance liquid chromatography coupled with quadruple-time-of-flight and electrospray ionization mass spectrometry (UPLC-Q/TOF-ESI-MS). The acid hydrolyzing dynamic changes of chemical compositions and the possible transformation pathways of saponins were monitored by ultrahigh-performance LC coupled with tandem MS (UHPLC-MS/ MS). Results and conclusion: Notoginsenoside Ft1 was epimerized from notoginsenoside ST4, which was generated through cleaving the carbohydrate side chains at C-20 of notoginsenosides Fa and Fc, and vinaginsenoside R7, and further converted to other compounds via hydroxylation at C-25 or hydrolysis of the carbohydrate side chains at C-3 under the acid conditions. High temperature contributed to the hydroxylation reaction at C-25 and 25% acetic acid concentration was conducive to the preparation of notoginsenoside Ft1. C-20 epimers of notoginsenoside Ft1 and ST4 were successfully separated utilizing solvent method of acetic acid solution. The theoretical preparation yield rate of notoginsenoside Ft1 was about 1.8%, which would be beneficial to further study on its bioactivities and clinical application.

The Guidelines for the Nomenclature of Drugs (의약품명명법 가이드라인)

  • Choi, Myoeng-Sin;Choi, Bo-Kyung;Han, Kyu-Won;Kim, Kil-Soo;Jang, Seung-Jae;Kang, Chan-Soon
    • Journal of Pharmaceutical Investigation
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    • v.32 no.4
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    • pp.331-337
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    • 2002
  • Nonproprietary name may be used without restriction by the public at large and can be called common name, generic name. Nomenclature agencies exist in US, Great Britain, Japan and so on. The agencies maintain liaison with onε another in an effort to secure the wide adoption of thε most appropriate and universally acceptable designation for each drug. To prevent the confusion which arises when several nonproprietary names are used for a single drug, either in the same country or in several different countries, the WHO has assumed the responsibility of coordination existing nomenclature at the international level. In this study, the nomenclature for new drugs and the terminology to harmonize specifications for revision of Korean Pharmacopoeia (KP) were established.

Cytotoxicity Evaluation on Hydrogels for Medical Devices based on the International Organization for Standardization (국제표준화기구 기준에 의한 의료기기용 하이드로겔의 세포독성 평가)

  • Kim, Hyun-Ki;Kim, Ye-Tae;Cho, Yang-Ha;Roh, Hye-Won;Kim, Min-A;Kim, So-Yeon;Huh, Kang-Moo;Park, Jeong-Sook
    • Journal of Pharmaceutical Investigation
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    • v.39 no.2
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    • pp.127-131
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    • 2009
  • Hydrogels for medical devices such as hydrophilic dressing, moisturizing healing band, hydrophilic intravenous catheter and soft contact lens were evaluated for their cytotoxicity according to the International Organization for Standardization (ISO) procedures. To test indirect cytotoxicity of hydrogel products, dissolution medium and dissolution condition were selected based on the guideline for medical devices. Cytotoxicity was low in all the case of hydrogel products. Soft contact lens showed no significant difference in dissolution between complete medium and saline. Currently, there is no specific guidelineto test hydrogel for medical devices in Korea with consideration of characteristics of hydrogel. Thus, proper method of cytotoxicity evaluation should be selected depending on the characteristics and usages of hydrogels for medical devices.