• Title/Summary/Keyword: ICH

Search Result 353, Processing Time 0.023 seconds

Spatial distribution of pigment concentration around the East Korean Warm Current region derived from Satellite data

  • Kim, Sang-Woo;Kim, Young-Seup;Yoon, Hong-Joo;Saitoh, Sei-ich
    • Proceedings of the KSRS Conference
    • /
    • 2002.10a
    • /
    • pp.655-655
    • /
    • 2002
  • Spatial distribution of phytoplankton pigment concentration (PPC) and sea surface temperature (SST) around the East Korean Warm Current (EKWC) was described, using both ocean color images and advanced very high resolution radiometer (AVHRR) images. Water mass in this region can be classified into five categories in the horizontal profile of PPC and SST, nLw(normalized water-leaving radiance) images: (1) coastal cold water region associated with concentrations of dissolved organic material or yellow colored substances and suspended sediments, (2) cold water region of thermal frontal occurred by a combination of phytoplankton absorption and suspended materials, (3) warm water overlay region by the phytoplankton absorption than the suspended materials; (4) warm water region occurred by the low phytoplankton absorption, and (5) offshore region occurred by the high phytoplankton absorption. In particular, the highest PPC area appeared in the ocean color and SST images with a band shaped distribution of the thermal front and ocean color front region, which is located the coastal cold waters along western thermal front of the warm streamer of the EKWC.

  • PDF

A Study on Amendment of Approval Specifications for Traditional Korean Medicines (한약제제 허가기준 개선방안 연구(I))

  • Han Byong-Hyon;Hwang Gwi-Seo
    • Journal of Society of Preventive Korean Medicine
    • /
    • v.5 no.1
    • /
    • pp.57-75
    • /
    • 2001
  • This study was conducted to improve the current regulation guidelines for developing traditional Korean medicines with effectiveness and productivity, in order to cope with the upcoming ICH on specifications on oriental herbal drugs. Also, major purposes of this study are to motivate R&D and to pioneer foreign markets for domestic herbal drug companies. First, after examining concepts of traditional Korean medicines and comparing the numbers and differentiation of herbal drugs registered on Pharmacopeia among Korea, China, and Japan, the current new drug development requirements for traditional Korean medicines were reviewed in detail, followed by comparison of foreign regulation systems including USA, EU, China, and Japan. Second, empirical cases on failure of development for new traditional Korean medicines under the current regulation system in the domestic companies including Dong-A, Kwangdong, and Samchondang, were collected and analyzed. As a result, hanbangsaengyak, the new category for traditional Korean medicines was newly developed on the basis of scientification of data between saengyak and hanyak, from the perspectives of harmonization between oriental medicine and western medicine and of balance between food and drug, in terms of industrialization, publicity, modernization, and effectiveness of administration. In addition, the new regulation requirements for the new hanbangsaengyak preparations were discussed by establishing principles of reinforcing preclinical test and of simplifying clinical trials in Korea. Finally, the further researches to articulate the complete specifications for pre-clinical and clinical requirements for traditional Korean medicines were strongly suggested.

  • PDF

Analytical Study on Inter-Cell Handover via Non-Concentric Circles in Wireless Heterogeneous Small Cell Networks

  • Gu, Hangyu;Li, Shuangchun;Havyarimana, Vincent;Wang, Dong;Xiao, Zhu
    • KSII Transactions on Internet and Information Systems (TIIS)
    • /
    • v.12 no.5
    • /
    • pp.2029-2043
    • /
    • 2018
  • In this paper, we propose a novel inter-cell handover approach from a new perspective in dense Heterogeneous and Small Cell Networks (HetSNets). We first devise a cell selection mechanism to choose a proper candidate small cell for the UEs that tend to implement inter-small cell handover (ICH). By exploiting the property of a typical non-concentric circle, i.e., circle of Apollonius, we then propose a novel analytical method for modeling inter-cell handover regions and present mathematical derivation to prove that the inter-small cell handover issues fit the property of the circle of Apollonius. We design an inter-cell handover algorithm (ICHA) by means of our proposed handover model to dynamically configure hysteresis margin and properly implement handover decision in terms of UE's mobility. Simulation results demonstrate that the proposed ICHA yields lower call drop rate and radio link failure rate than the conventional methods and hence achieve high Handover Performance Indicator (HPI).

Analytical Method Validation of (-)Epicatechin gallate in Penthorum chinense Pursh Extract using HPLC

  • Kwon, Jin Gwan;Jung, Yeon Woo;Seo, Changon;Hong, Seong Su;Lee, Ji Eun;Shin, Hyun Tak;Jung, Su Young;Choi, Chun Whan;Kim, Jin Kyu
    • Proceedings of the Plant Resources Society of Korea Conference
    • /
    • 2019.04a
    • /
    • pp.100-100
    • /
    • 2019
  • This study attempted to establish a High Performance Liquid Chromatography (HPLC) analysis method for the determination of (-)-epicatechin gallate as a part of the quality control for the development of functional cosmetic materials from Penthorum chinense Pursh extracts. HPLC was performed on a Unison US-C18 column ($4.6{\times}250mm$, $5{\mu}m$) with a gradient elution of 0.05% (v/v) trifluoroacetic acid (TFA) and methyl alcohol at a flow rate of 1.0 mL/min at $30^{\circ}C$. The analyte was detected at 280 nm. The HPLC method was performed in accordance with the International Conference on Harmonization (ICH) guideline (version 4, 2005) of analytical procedures with respect to specificity, precision, accuracy, and linearity. The limits of detection and quantitation were 0.11 and 0.33 mg/mL, respectively. Calibration curves showed good linearity (r2 > 0.9999), and the precision of analysis was satisfied (less than 0.6%). Recoveries of quantified compounds ranged from 99.51 to 101.92%. This result indicates that the established HPLC method is very useful for the determination of marker compound in P. chinense Pursh extracts.

  • PDF

New evaluation of ship mooring with friction effects on mooring rope and cost-benefit estimation to improve port safety

  • Lee, Sang-Won;Sasa, Kenji;Aoki, Shin-ich;Yamamoto, Kazusei;Chen, Chen
    • International Journal of Naval Architecture and Ocean Engineering
    • /
    • v.13 no.1
    • /
    • pp.306-320
    • /
    • 2021
  • To ensure safe port operations around the world, it is important to solve mooring problems. In particular, the many ports that face open seas have difficulties with long-period waves. As a countermeasure, the installation of a breakwater is proposed for mooring safety. However, this often cannot be put into practice because of financial issues. Instead, port terminals control berthing schedules with weather forecasting. However, mooring problems remain unsolved, because of inaccurate wave forecasting. To quantify the current situation, numerical simulations are presented with ship motions, fender deflections, and rope tensions. In addition, novel simulations for mooring ropes are proposed considering tension, friction, bending fatigue, and temperature. With this novel simulation, the optimal mooring method in terms of safety and economic efficiency was confirmed. In terms of safety, the optimal mooring method is verified to minimize dangerous mooring situations. Moreover, the optimal mooring method shows economic benefits and efficiency. It can help to reinforce the safety of port terminals and improve the efficiency of port operations.

Analytical Quality by Design Methodology Approach for Simultaneous Quantitation of Paeoniflorin and Decursin in Herbal Medicine by RP-HPLC Analysis

  • Kim, Min Kyoung;Park, Geonha;Hong, Seon-Pyo;Jang, Young Pyo
    • Natural Product Sciences
    • /
    • v.27 no.4
    • /
    • pp.264-273
    • /
    • 2021
  • Simultaneous quantification of multiple marker compounds in herbal medicine by high performance liquid chromatography (HPLC) analysis is still a challenge due to the complexity in various parameters to be considered and co-existing multi-components. As a case study, a reliable HPLC method for simultaneous quantification of paeoniflorin from Paeoniae Radix and decursin from Angelicae Gigantis Radix in various commercial herbal medicine was developed based on analytical quality by design (AQbD) strategy. As a first step, risk assessment was performed to select the critical method parameters (CMPs) which were decided as organic mobile phase ratio and column oven temperature. In order to evaluate the effect of the CMPs on critical method attributes (CMAs) of peak resolution and tailing, central composite design (CCD) was employed. The final chromatographic conditions were optimized as follows: column- C18, 4.6 × 250 mm, 5 ㎛ particle size; mobile phase- A: acetonitrile, B: 0.1% acetic acid water; detection wavelength- 235 nm for paeoniflorin, 325 nm for decursin; column oven temperature- 25℃; flow rate- 1.0 mL/min; gradient mobile phase system as Time (min) : % A, 0:14, 25:14, 30:50, 60:50, 61:100, 65:100, 66:14, 75:14. The method was successfully validated according to the International Conference on Harmonization (ICH) guidelines and piloted for ten commercial herbal medicines.

Automated radiosynthesis for the routine production of [18F]FPEB for imaging metabotropic glutamate receptor 5 (mGluRS)

  • Kyung Rok Nam;Sang Jin Han;Kyo Chul Lee;Jae Yong Choi
    • Journal of Radiopharmaceuticals and Molecular Probes
    • /
    • v.8 no.1
    • /
    • pp.3-8
    • /
    • 2022
  • Alteration of the mGluR5 density is closely related to various brain diseases including schizophrenia, depression, Parkinson's disease, and Alzheimer's disease. Therefore, mGluR5 is considered as a valuable imaging biomarker for brain disease and many radiopharmaceuticals have been developed so far. Among them, [18F]FPEB has favorable pharmacokinetic characteristics, and this is the most frequently used radiopharmaceutical for preclinical and clinical studies. In the present study, we want to introduce the optimized radiosynthetic method for the routine production of [18F]FPEB using a GE TRACERlabTM FXFN pro module. In addition, the entire process was monitored with a webcam to solve the problems arising from the synthetic process. As a result, [18F]FPEB was prepared by nucleophilic substitution from its nitro- precursor at 120℃ for 20 min in dimethyl sulfoxide. Radiochemical yield was 13.7 ± 5.1% (decay-corrected, n = 91) with the molar activity of 84 ± 17 GBq/µmol at the end of synthesis. The radiochemical purity was determined to be above 96%. The manufactured [18F]FPEB injection for quality controls were carried out in accordance with an KIRAMS approved protocol, as per ICH and USP guidelines.

Numerical Study on Heat Transfer Performance of PCHE With Supercritical CO2 as Working Fluid (초임계 이산화탄소를 작동유체로 하는 인쇄기판형 열교환기의 형상변수에 따른 전열성능 수치모사)

  • Jeon, Sang Woo;Ngo, Ich-long;Byon, Chan
    • Transactions of the Korean Society of Mechanical Engineers B
    • /
    • v.40 no.11
    • /
    • pp.737-744
    • /
    • 2016
  • The printed circuit heat exchanger (PCHE) is regarded as a promising candidate for advanced heat exchangers for the next-generation supercritical $CO_2$ power generation owing to its high compactness and rigid structure. In this study, an innovative type of PCHE, in which the channel sizes for the heat source fluid and heat sink fluid are different, is considered for analysis. The thermal performance of the PCHE, with supercritical $CO_2$ as the working fluid, is numerically analyzed. The results have shown that the thermal performance of the PCHE decreases monotonically when the channel size of either the heat source channel or the heat sink channel, because of the decreased flow velocity. On the other hand, the thermal performance of the PCHE is found to be almost independent of the spacing between the channels. In addition, it was found that the channel cross sectional shape has little effect on the thermal performance when the hydraulic diameter of the channel remains constant.

Recent Advanced Toxicological Methods for Environmental Hazardous Chemicals (환경 오염물질의 진보된 독성 평가 기법)

  • 류재천;최윤정;김연정;김형태;방형애;송윤선
    • Environmental Analysis Health and Toxicology
    • /
    • v.14 no.1_2
    • /
    • pp.1-12
    • /
    • 1999
  • Recently, several new methods for the detection of genetic damages in vitro and in vivo based on molecular biological techniques were introduced according to the rapid progress in toxicology combined with cellular and molecular biology. Among these methods, mouse lymphoma thymidine kanase (tk) gene forward mutation assay, single cell gel electrophoresis (comet assay) and transgenic animal and cell line model as a target gene of lac I (Big Blue) and lac Z (Muta Mouse) gene mutation are newly introduced based on molecular toxicological approaches. The mouse lymphoma tk$\^$+/-/ gene assay (MOLY) using L5178Y tk$\^$+/-/ mouse lymphoma cell line is one of the mammalian forward mutation assays, and has many advantages and more sensitive than hprt assay. The target gene of MOLY is a heterozygous tk$\^$+/-/ gene located in 11 chromosome, so it is able to detect the wide range of genetic changes like point mutation, deletion, rearrangement, and mitotic recombination within tk gene or deletion of entire chromosome 11. The comet assay is a rapid, simple, visual and sensitive technique for measuring and analysing DNA breakages in mammalian cells, Also, transgenic animal and cell line models, which have exogenous DNA incorporated into their genome, carry recoverable shuttle vector containing reporter genes to assess endogenous effects or alteration in specific genes related to disease process, are powerful tools to study the mechanism of mutation in vivo and in vitro, respectively. Also in vivo acridine orange supravital staining micronucleus assay by using mouse peripheral reticulocytes was introduced as an alternative of bone marrow micronucleus assay. In this respect, there was an International workshop on genotoxicity procedure (IWGTP) supported by OECD and EMS (Environmental Mutagen Society) at Washington D. C. in March 25-26, 1999. The objective of IWGTP is to harmonize the testing procedures internationally, and to extend to finalization of OECD guideline, and to the agreement of new guidelines under the International Conference of Harmonization (ICH) for these methods mentioned above. Therefore, we introduce and review the principle, detailed procedure, and application of MOLY, comet assay, transgenic mutagenesis assay and supravital staining micronucleus assay.

  • PDF

Development of Guidance on the Pharmacokinetic Studies of Therapeutic Biologics (생명공학의약품의 약동학 시험 지침 개발 연구)

  • Lee, Hae-Won;Lim, Mi-Sun;Seong, Sook-Jin;Lee, Joo-Mi;Park, Sung-Min;Noh, Keum-Han;Park, Sung-Ho;Kim, Eun-Jung;Kang, Won-Ku;Yoon, Young-Ran
    • Korean Journal of Clinical Pharmacy
    • /
    • v.22 no.1
    • /
    • pp.21-29
    • /
    • 2012
  • Modern biologics are biotechnology-derived therapeutics, including recombinant therapeutic proteins like monoclonal antibodies, cytokines and tissue growth factors. Although the pharmacokinetics of therapeutic biologics should be evaluated based on the same general principles as small molecules, careful considerations should be given to bioanalytics and pharmacokinetics when designing pharmacokinetic studies of biologics during their drug development, due to their different physicochemical properties compared with small molecules. The aim of this study was to develop a draft guidance on pharmacokinetic studies of therapeutic biologics in clinical studies. All the elements outlined in the current Food and Drug Administration (FDA), European Medicinal Agency (EMEA), and International Conference on Harmonisation (ICH) guidelines and regulations, and the related literatures previously published were searched and evaluated. In this draft guidance, the specific problems related to the pharmacokinetics of therapeutic biologics that need special consideration during drug development process were addressed, and differences in pharmacokinetic characteristics between biologics and small molecules affecting the content of the development programme were presented.