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임상시험용 의약품의 안전성 정보 보고 제도 : 국제의약품규제조화위원회의 가이드라인 및 미국, 유럽, 일본의 제도를 중심으로
박순제,심다영,박상준,이하은,신주영 한국보건사회약료경영학회 2021 한국보건사회약료경영학회지 Vol.9 No.1
The Development Safety Update Report(DSUR) is the periodic safety report on drugs under clinical trials( including marketed drugs that are under further study). The main objective of a DSUR is to present a comprehensive, thoughtful annual review and evaluation of pertinent safety information collected during the reporting period. The guidelines of International Council of Harmonization(ICH) play a standard role in pharmaceutical industries among the ICH regions(including U.S., EU and Japan) and in the case of DSUR, ICH guidelines E2F(ICH E2F) works as a standard. Those countries above(U.S., EU and Japan) already establish DSUR systems based on ICH E2F and in South Korea, Ministry of Food and Drug Safety(MFDS) is planned to implement the DSUR and make the submission mandatory gradually from 2021 to 2024. So in this report, with the implementation of the DSUR ahead off, we first reviewed ICH E2F guideline and compared with the DSUR systems of U.S., EU and Japan, then we discuss current situation and implication in South Korea including specific plan, legislation and advantages it would offer.
韓國 東亞棉의 種分類에 關한 細胞學的 硏究 : Ⅰ. 韓國東亞棉 ×G. arboreum 檢定種
許文會,박순제 서울대학교 1968 서울대학교 論文集 Vol.19 No.-
Sixteen Asiatic cotton varieties collected from Korea, Manchuria, China and Japan were crossed to G.arboreum tester stocks to identify their species. From the cytological results that very few meiotic irregularities were observed, those Asiatic collections tested are considered to belong to G. arboreum.
산화티탄 광촉매를 이용한 VOC 가스 처리효과에 관한 연구
윤석영,노준형,박순제,이승호,Yun, Seok-Yeong,No, Jun-Hyeong,Park, Sun-Je,Lee, Seung-Ho 한국재료학회 2000 한국재료학회지 Vol.10 No.5
The photocatalyst of $TiO_2$coated on glass bead was prepared from sol-gel method to remove the VOC (vola-tile organic compounds) by the photocatalytic reaction. The coated films were characterized by X-ray diffraction(XRD), specific surface area(BET), and scanning electron microscopy observation (SEM), The gas-phase photocatalytic degradation of trichloroethylene(TCE) and benzene with coated titanium dioxide on glass beads was in-vestigated using a fixed bed reactor. The degradation was calculated by the concentration difference with the retained on the reactor with aid of gas chromatography. At steady state, conversion yields were obtained for 80% of trichloroeth-vlene in 400 ppmv concentration and 65% on benzene in the range of concentration from 50 to 300 ppmv, respectively. 산화티탄의 광촉매 반응을 이용하여 휘발성 유기화합물(VOC)를 분해제거 하기 위하여 산화티탄을 glass bead에 sol-gel법으로 코팅하였다. 코팅막의 물성은 XRD, BET, SEM을 통해 분헉하였으며, 산화티탄이 galss bead를 채운 실험실규모의 광촉매 반응기를 이용 VOC중 벤젠 및 TCE 가스의 광촉매반응에 의한 분해효율에 대해 연구 컴토하였다. 반응기내의 잔류시간에 따른 가스농도 차이를 gas chromatography로 비교 분석하여 그 분해효율을 계산하였다. 이와 같은 정적인 상태의 실험결과, 400ppmv의 농도의 TCE인 경우 80%의 분해효율을 얻었으며, 50ppmv에서 300ppmv 농도의 벤젠인 경우 65%의 분해효율을 얻었다.
한국동아면의 종분류에 관한 세포학적 연구 -II. 한국동아면 ${\times}$ G. herbaceum 검정종
허문회,채영암,박순제,Mun-Hue Heu,Young-Am Chae,Soon-Jai Park 한국작물학회 1969 Korean journal of crop science Vol.- No.7
To make clear the species of Korean Asiatic cotton, 21 Asiatic cotton varieties collected from China, Manchuria, Japan and Korea and preserved at suwon Crop Experiment Station were crossed to the tester stocks and cytological studies were made for their $F_1$ pollen mother cells. The results were summarized as follows: 1. In the all $F_1$ hybrids between the 21 collections and G. herbaceum tester stocks always one ring-four association was observed. 2. In the $F_1$ hybrids between additional 5 collections and G. arboreum tester stock ring-four or chain-four was not observed. 3. In the $F_1$ hybrids between G. herbaceum tester stocks and between G. arboreum tester stocks no ring-four or chain-four was observed, while in the $F_1$ hybrids between G. herbaceum tester stock and G. arboreum tester stock always one ring-four was observed. In the $F_1$ hybrids between collections also no ring-four or chain-four was observed. 4. From above results and together with the results reported in previous paper the species of Asiatic collections was inferred to the D.U. Gerstel's G. arboreum and their race was inferred to the J. Hutcinson's G. arboreum L. race sinense. 한국에 재배되어 온 동아면의 종을 밝히고져 한국 및 중국 제주 일본등지에서 귀집 보존되어 오는 21개 품종을 검정종과 교배하여 그 $F_1$ 의 화분모세포를 세포학적으로 검토하였는데 그 결과 및 결론은 다음과 같다. 1. 귀집종과 G. herbaceum 검정종과의 $F_1$에서는 항상 1개의 4련염색체가 나타났다. 2. 추가된 귀집종과 G. arboreum 검정종과의 $F_1$에서는 전보에서와 같이 4련염색체가 나타난 조합이 없었다. 3. G. herbaceum의 검정종간에서나 G. arboreum검정종간에서는 4련염색체가 나타나지 않았고 G. herbaceum 검정종과 G. arboreum 검정종간에서는 항상 1개의 4련염색체가 관찰되었다. 4. 귀집종간의 $F_1$에서도 4련염색체를 볼수 없었다. 5. 이상의 결과를 Gerstel의 세포학적 근거에 비쳐 공시된 귀집종들은 G. arboreum에 속하는 것이라고 추정하고 race에 관해서는 Hutchinson의 지리적 분포론에 따라 race sinense라고 함이좋을 것이라고 고찰하였다.