• 제목/요약/키워드: PMDA

검색결과 53건 처리시간 0.015초

한약을 사용하는 아시아권 국가의 유해사례 보고 양식에 관한 비교 연구 (Comparison about adverse drug reaction report forms among Asian's countries using herbal medicine)

  • 선승호;이은경;장보형;박선주;고호연;전찬용;고성규
    • 대한예방한의학회지
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    • 제19권3호
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    • pp.91-102
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    • 2015
  • Objective : The purpose of this study is to find out the possibility of application to herbal medicine's report form for adverse drug reaction (ADR) by reviewing and analyzing Asian countries's ADR report forms. Method : We investigated, compared, and analyzed ADR report forms (ADR-RF) of Asian countries's ADR institutions (ACAI), such as, Korea institute of drug safety & risk management and Dongguk university Ilsan oriental hospital (DUIOH) in Korea, national center for ADR monintoring (NCAM) in China, pharmaceuticals and medical devices agency (PMDA) in Japan, Ministry of Health and Welfare (MOHW) in Taiwan, and drug office, department of health, the government of the Hong Kong special administrative region (GHKSAR) in Hong Kong. Results : ADR-RF for ACAI included common contents, such as, patients information (name(initial), gender, age, weight), adverse event (AE)'s report information (Recognition and report for AE occurrence, first or follow up report, Severe AE), the detailed information of AE (the title of AE, onset & closing date of AE symptoms, the progress & results detailed test of AE), the information of AE's medicine (the types of medicine, product name, ingredient name, suspected or combination drug, single dose & frequency, dosage form, administration route, dealing for AE-suspected medicine), and AE reporter's information (reporter's information, institution's information). Taiwan had ADR-RF and the department exclusively for herbal medicine (HM), but others (except DUIOH) had not only no ADR report form but also contents for HM. Conclusion : ADR-RF for HM have to include the common contents of ACAI at least, as well as HM information related to ADR, such as the title, composition and types of HM, history related to HM's ADR, and the contents of drug-induced liver injury and so on. In addition, the main department of government for HM's ADR will be needed.

알킬기가 도입된 올리고 아믹산 구조를 가진 고내열 친유기 층상 실리케이트의 제조 및 이를 이용한 나노복합재의 특성평가 (Synthesis and Characterization of Heat Resistant Organophilic Layered Silicate Modified with Oligo(amic acid)s Having Alkyl Side Chains and Their Nanocomposites)

  • 한지연;원종찬;이재홍;서경도;김용석
    • 폴리머
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    • 제29권5호
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    • pp.451-456
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    • 2005
  • 폴리이미드 나노복합재의 나노충전제를 설계함에 있어 가장 중요한 요소는 나노충전제의 내열성 및 매트릭스 고분자인 폴리이미드와의 상용성이다. 본 연구에서는 두 가지의 요소를 만족시키기 위하여, 알킬사슬을 가지며 말단기가 아민인 올리고 아믹산을 설계하였고 이를 이용하여 층상 실리케이트의 표면을 개질하는 연구를 수행하였다. 분자량이 2000g/mol로 조절되고 말단기가 아민인 올리고 아믹산을 제조하였고 이후 이온 교환반응을 통하여 고내열 친유기 층상 무기소재를 제조하였다. 본 연구에서 제조된 고내열 친유기 층상 무기물은 TGA로 분석한 결과 초기분해 온도가 $280^{\circ}C$ 이상이었으며, XRD로 분석한 결과, 개질하지 않은 층상 무기물에 비해 최소 $4{\AA}$ 이상의 층간거리 증가를 나타내었다. 또한 이들의 나노복합필름의 경우 X선 실험을 통해 친유기성 층상 무기물이 고르게 분산되어 있음을 알았으며, 친유기성 층상 무기물의 함량이 증가함에 따라 CTE 역시 최대 $26\%$ 감소함을 TMA실험 결과를 통해 확인하였다.

규제과학 및 규제과학 전문가 양성 프로젝트의 국내외 동향분석: 미국, 일본, 싱가포르, 한국을 중심으로 (Analysis of Trends in Regulatory Science and Regulatory Science Experts Training Projects: US, Japan, Singapore, and Korea)

  • 박재홍;신호철;김지원;김민수;도인구;임희연;이지원;이윤지;정선영;강원구;김하형;최영욱;김은영
    • 한국임상약학회지
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    • 제31권4호
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    • pp.257-267
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    • 2021
  • Background: The need for regulatory science development to evaluate advanced regulatory products is gradually increasing without hindering the technological development. Creating a research environment and fostering experts through the establishment of regulatory agency-led policies are essential for the development of regulatory science. Method: This is a comparative study of the United States, Japan, Singapore, and Korea. The literature and websites of each regulatory agency were reviewed, and the focus was on advantages and comparing advantages based on definition, development trends, and expert training projects. Results: The United States is striving to develop regulatory science in response to changes in the new pharmaceutical industry through the regulatory science report, and to foster expert both inside and outside the Food and Drug Administration (FDA). Japan is promoting regulatory science centered on regulatory science centers, and is focusing on researching work-related regulatory science within the Pharmaceuticals and Medical Devices Agency (PMDA) and improving employees' ability to make regulatory decisions. Singapore was aiming to improve Southeast Asia's regulatory capabilities under the leadership of Centre of Regulatory Excellence (CoRE) within Duke-NUS University. In 2021, Korea is in its early stages, starting to run a university's degree program related to regulatory science this year. Conclusion: Regulatory science should be developed with the aim of improving the regulatory ability of the Ministry of Food and Drug Safety with Korea's independent concept of regulatory science.