• 제목/요약/키워드: Physicochemical factors

검색결과 310건 처리시간 0.034초

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

  • 이혜원;임미선;성숙진;이주미;박성민;노금한;박성호;김은정;강원구;윤영란
    • 한국임상약학회지
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    • 제22권1호
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    • pp.21-29
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    • 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 The aim of this study was to develop a draft guidance on pharmacokinetic studies of therapeutic biologics in clinical studies.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 In this draft guidance, the specific problems related to the pharmacokinetics of therapeutic biologics that need special consideration during drug development process were addressed,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.

Effects of Onion Powder and Baking Temperature on the Physicochemical Properties of Cookies

  • Kim, Hye-Ran;Seog, Eun-Ju;Lee, Jun-Ho
    • Preventive Nutrition and Food Science
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    • 제12권3호
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    • pp.160-166
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    • 2007
  • Response surface methodology (RSM) was used for the optimization of the baking process of cookies made with onion powders (onion cookie). Experiments were carried out according to a central composite design, selecting onion powder content $(1.15{\sim}8.86%)$ and baking temperature $(155.9{\sim}184.1^{\circ}C)$ as independent variables and pH, titratable acidity, moisture content, density, spread factor, CIE color parameters $(L^{\ast}-$, $a^{\ast}-$, and $b^{\ast}-values)$, and hardness as response variables. pH decreased with increasing amount of onion powder and baking temperature. Moisture content also decreased as the baking temperature increased. $L^{\ast}-$ and $b^{\ast}-values$ decreased but $a^{\ast}-values$ increased with increasing onion content and baking temperature. Most polynomial models developed by RSM were highly effective to describe the relationships between the studied factors and the responses. Overall optimization, conducted by overlaying the contour plots under investigation, was able to point out the optimal range of the independent variables within which the six responses were simultaneously optimized. The point chosen as representative of this optimal region corresponded to 4.01% onion powder content and $161.84^{\circ}C$ baking temperature. The predicted dependent or response values in the optimal region were: pH=6.87, moisture content=2.77%, $L^{\ast}-value=68.45$, $a^{\ast}-value=1.98$, $b^{\ast}-value=34.64$, and spread factor=9.41.

J 하수 처리장 방류수 중 세균의 성장 거동 및 염소 소독 효율 고찰 (Study on Microorganism Multiplication Behavior and Efficiency of Chlorine Disinfection in the Sewage Effluent from J Municipal Waste Water Treatment Plant)

  • 이운기;이윤진;정규연
    • 공업화학
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    • 제19권1호
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    • pp.122-128
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    • 2008
  • 본 연구에서는 J 하수 처리장의 최종 방류수를 대상으로 종속영양세균의 증식과 수중 물리, 화학적 영향인자와의 관계를 고찰하였다. 하수 중의 용존 유기물질 농도는 종속영양세균의 성장과 가장 밀접한 관계를 보였다. 미생물의 영양원인 단백질, 지방, 전분, 섬유소, 팩틴의 분해 세균 분포를 파악한 결과 하수 중 단백질 및 지방세균의 비율은 전체의 81%로 가장 높았다. 종속영양세균은 연중 8월에 가장 높은 수치를 나타냈다. 하수 방류수에 대해 10 mg/L의 유리염소를 주입하여 15 min간 접촉시 THMs의 농도는 $71{\mu}/L$ (< $100{\mu}/L$- 먹는 물 수질기준)의 값을 나타내어 높지 않았다.

Effect of Transglutaminase Addition on the Physicochemical Properties of Sodium Caseinate and Whey Proteins

  • Jeong, Ji-Eun;Hong, Youn-Ho
    • 한국축산식품학회지
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    • 제29권4호
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    • pp.415-422
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    • 2009
  • In this study, several factors were analyzed in an effort to determine the effects of transglutaminase (TGase) treatment on sodium caseinate (NaCN), ${\alpha}--lactalbumin$ (${\alpha}-La$), and ${\beta}-lactoglobulin$ (${\beta}-Lg$) polymerization reactions. The results of SDSPAGE showed that NaCN was slightly hydrolyzed to molecular weights of 50-400 kDa according to activation time. ${\alpha}-La$ formed high-molecular polymers of 30-300 kDa, whereas ${\beta}-Lg$ remained almost completely unhydrolyzed. Melting temperatures of NaCN, ${\alpha}-La$ with and without TGase were all in the range of $100{\pm}10^{\circ}C$ under the endothermic curve, and the melting temperature of ${\beta}-Lg$ with TGase was lower than that with TGase. When the proteins were incubated for 3 h with TGase, the micrographic structures showed a small quantity of sediment and broad layers. The final ${\alpha}-La$ residues remained at a level of 21.38%, and the TGase-treated ${\alpha}-La$ was confirmed to have undergone a profound loss of mass, to 18.25%. The DPPH-radical scavenging activity of NaCN and ${\beta}-Lg$ with TGase treatment was higher than that observed in the untreated sample, while those of ${\alpha}-La$ increased with concentration.

인조기판 위에서 해양 부착생물의 발달 및 천이 (Development and Succession of Marine Fouling Organisms on Artificial Substrata)

  • 심재형;정문섭
    • 한국해양학회지
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    • 제22권4호
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    • pp.257-270
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    • 1987
  • 1982-1983년 진해항 및 마산만에서 발달하는 부착생물 군집을 슬라이드 글라스 및 浸漬基板실험에 의하여 연구하였다. 15일의 침적실험후 세균의 개체수는 1.7$\times$$10^{4}$CFU/$cm^{2}$로 산출되었고, 微小生物群集에서 발달한 저생 규조류 는 총 46분류군이었다. 부착생물군집의 順次的 변화과정을 명백히 볼 수 있었고, 우 점 규조류 종은 Licmophora flavellata, Navicula grevillei, 및 Nitzschia closterium 로 나타났다. 대형생물군집의 주요 종은 Mytilus edulis, Balanus amphitrite mphitrite, Hydroides ezoensis및Celleporina sp. 로서 5개월의 침적후에 500g/100cm $^{2}$이상의 생물량을 보였다. 두 조사해역에서의 군집발달양상이 큰 차이를 보이 는데 이는 주로 주변수의 물리화학적 안정성 및 영양상태에 기인하는 것으로 판단 된다. 부착생물군집의 발달과정은 유생의 생성시기 및 성장률에 매우 큰 영향을 받 는 것으로 밝혀졌고, 군집발달의 전 과정은 다음과 같이 요약이 된다. 세균 및 규조류-다세포해조류-따개비류, 홍합류 및 다모류-해면류, 말미잘류 및 해초류.

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PMF모델을 이용한 대기 중 PM-10 오염원의 정량적 기여도 추정 (Estimation of Quantitative Source Contribution of Ambient PM-10 Using the PMF Model)

  • 황인조;김동술
    • 한국대기환경학회지
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    • 제19권6호
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    • pp.719-731
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    • 2003
  • In order to maintain and manage ambient air quality, it is necessary to identify sources and to apportion its sources for ambient particulate matters. The receptor methods were one of the statistical methods to achieve reasonable air pollution strategies. Also, receptor methods, a field of chemometrics, is based on manifold applied statistics and is a statistical methodology that analyzes the physicochemical properties of gaseous and particulate pollutant on various atmospheric receptors, identifies the sources of air pollutants, and quantifies the apportionment of the sources to the receptors. The objective of this study was 1) after obtaining results from the PMF modeling, the existing sources of air at the study area were qualitatively identified and the contributions of each source were quantitatively estimated as well. 2) finally efficient air pollution management and control strategies of each source were suggested. The PMF model was intensively applied to estimate the quantitative contribution of air pollution sources based on the chemical information (128 samples and 25 chemical species). Through a case study of the PMF modeling for the PM-10 aerosols, the total of 11 factors were determined. The multiple linear regression analysis between the observed PM-10 mass concentration and the estimated G matrix had been performed following the FPEAK test. Finally the regression analysis provided quantitative source contributions (scaled G matrix) and source profiles (scaled F matrix). The results of the PMF modeling showed that the sources were apportioned by secondary aerosol related source 28.8 %, soil related source 16.8%, waste incineration source 11.5%, field burning source 11.0%, fossil fuel combustion source 10%, industry related source 8.3%, motor vehicle source 7.9%, oil/coal combustion source 4.4%, non-ferrous metal source 0.3%. and aged sea- salt source 0.2%, respectively.

Biotic ligand model에 근거한 중금속 오염지역의 Pb 및 Cd 위해오염도 평가기법 개발 (Assessment of Risk Based Pollution Level of Pb and Cd in Metal Contaminated Soils Using Biotic Ligand Model)

  • 안진성;정슬기;문희선;남경필
    • 한국지하수토양환경학회지:지하수토양환경
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    • 제16권4호
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    • pp.23-30
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    • 2011
  • Risk based pollution level of Pb and Cd in metal contaminated soils depending on physicochemical properties of soil in a target site was assessed using biotic ligand model. Heavy metal activity in soil solution defined as exposure activity (EA) was assumed to be toxic to Vibrio fischeri and soil organisms. Predicted effective activity (PEA) determined by biotic ligand model was compared to EA value to calculate risk quotient. Field contaminated soils (n = 10) were collected from a formes area and their risk based pollution levels were assessed in the present study using the calculated risk quotient. Concentrations of Pb determined by aqua regia were 295, 258, and 268 mg/kg in B, H and J points and concentrations of Cd were 4.73 and 6.36 mg/kg in G and I points, respectively. These points exceeded the current soil conservation standards. However, risk based pollution levels of the ten points were not able to be calculated because concentrations of Pb and Cd in soil solution were smaller than detection limits or one (i.e., non toxic). It was because heavy metal activity in soil solution was dominant toxicological form to organisms, not a total heavy metal concentration in soil. In addition, heavy metal toxicity was decreased by competition effect of major cations and formation of complex with dissolved organic carbon in soil solution. Therefore, it is essential to consider site-specific factors affecting bioavailability and toxicity for estimating reliable risk of Pb and Cd.

Rhizopus nigricans 에 의한 Progesterone 의 Hydroxylation(I): 반응 조건의 영향 (Progesterone Hydroxylation by Rhizopus nigricans(I): The effects of reaction conditions)

  • 김명희;김말남
    • 한국균학회지
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    • 제15권1호
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    • pp.23-28
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    • 1987
  • R. nigricans Ehrenberg 에 의한 progesterone 의 $11{\alpha}-hydroxyprogesterone$에 영향을 미치는 여러 물러 화학적 요인에 대하여 조사하였다. Progesterone의 농도가 낮을수록 $11{\alpha}-hydroxyprogesterone$이 최고의 수득율에 도달하는데 소요되는 시간이 짧았으며, 높은 기질 농도에서의 Progesterone은 $11{\alpha}-hydroxyprogesterone$의 hydroxylation을 저해하였다. 이 반응에 대한 최적 pH와 온도 범위는 비교적 넓은 범위로 나타났으며, 균사제의 성장 죄적 조건과 유사하였다. 일정 속도 이상의 진탕 속도와 당류들은 $11{\alpha}-hydroxyprogesterone$ 반응을 촉진시키는 효과를 보였으매, 균사체에서 보다 포자를 효소원으로 사용하였을 때 glucose의 효과는 더 크게 나타났다. 유기 용매는 효소 활성 저해제로 작용하었으며, 저해 정도는 유기 통매 농도가 높을수록, 용매에 처리한 시간이 길어질수록 높게 나타났다.

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도시공원의 생태기능 향상을 위한 토양 이화학적 특성 기준에 대한 연구 (Study on Soil Physico-Chemical Properties Criteria for Improving Ecosystem Services in Urban Parks)

  • 공민재;권태근;김창현;김남춘;신유경;안난희;이상민;손진관
    • 한국환경과학회지
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    • 제29권4호
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    • pp.325-337
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    • 2020
  • The purpose of this study was to analyze the soil environment of urban neighborhood parks and to use them as basic data for evaluating the ecological functions of urban parks such as groundwater regeneration, flood control, microclimate regulation, adsorption and purification. The landscape design criteria were generally evaluated as advanced, and further monitoring and studies are needed to evaluate the various ecological functions. It is also necessary to improve the phosphoric acid and nitrogen contents, which tended to be low. In addition, continuous monitoring is needed to assess the proper soil environment according to the biological species, and to evaluate the ecological functions. The results of this study can be used to evaluate the groundwater recharge of urban parks. In particular, when the land of the neighboring park is used for various purposes, the level of access of the user may be increased. Therefore, factors that may adversely affect the user's health, such as heavy metals and organic matters, should be selected and selected as management criteria. In addition, follow-up studies considering fertilization standards suitable for trees and growth of introduced vegetation, etc. are needed urgently to improve the soil environment.

쌀의 품질평가 현황과 전망 (Trend and Prospect of Rice Quality Evaluation)

  • 김재현;이정일;윤영환;김제규;황흥구;문헌팔;손종록
    • 한국작물학회:학술대회논문집
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    • 한국작물학회 2002년도 춘계 학술대회지
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    • pp.53-57
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    • 2002
  • Quality evaluation must be more developed in order to offer the sufficient information for producer, distribution centers buyer, consumer. There are many parameters which influence the rice quality and cooked rice. It is difficult to evaluate the quality of rice and cooked rice by only some parameters. In the case of rice quality evaluation in Korea, physicochemical inspection is performed by examining the minimum and maximum limits of brown rice recovery, moisture content, damaged kernel, and colored kernel as inspection standard. Marketing standard of rice defines the limits of perfect, white core and belly, colored, damaged kernels, and broken rice, classifying into special, excellent, and normal grades. As a research direction for the development of rice quality evaluation, establishment as parts of technical field, must be further developed as follows : more detailed measure of characters, search of unknown taste-related components, creation and grade classification of quality evaluation factors at each management stages of treatment after harvesting, evaluation as food material as well as cooking rice, method development for simple evaluation and establishment of equation for palatability. In the side of policy, the following concerns must be conducted: price discrimination in conformity to rice cultivar and grade under the basis of qualify evaluation method developed, fixation of head rice branding, and introduction of low temperature circulation.

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