• 제목/요약/키워드: human trial

검색결과 438건 처리시간 0.023초

Rapid and Sensitive Analysis of Valproic Acid in Human Red Blood Cell by LC-MS/MS

  • Han, Song-Hee;Kim, Yun-Jeong;Jeon, Ji-Young;Hwang, Min-Ho;Im, Yong-Jin;Jeong, Jin-A;Lee, Chang-Seop;Chae, Soo-Wan;Kim, Min-Gul
    • Bulletin of the Korean Chemical Society
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    • 제33권5호
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    • pp.1681-1685
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    • 2012
  • A sensitive liquid chromatography-tandem mass spectrometric (LC-MS/MS) method was developed to determine valproic acid in human red blood cell (RBC). It is important to measure the drug concentration of the RBC as well as that of the plasma because of drug partitioning for pharmacokinetic and pharmacodynamic study. The method was linear over the dynamic range of 1-100 ${\mu}g$/mL with a correlation coefficient $r$ = 0.9997. The linearity of this method was established from 1 to 100 ${\mu}g$/mL for valproic acid in red blood cell with accuracy and precision within 15% at all concentrations. The intra-run and inter-run assay accuracy and coefficient of variations are all within 15% for all QC samples prepared in plasma and red blood human samples. Then, valproic acid amount by protein precipitation in plasma was quantified by LC-MS/MS mass spectrometry. The distribution ratio of VPA in RBC and plasma was analyzed by clinical samples. Based on measurement of the valproic acid in human red blood cell, this method has been applied to clinical research for study of distribution ratio of valproic acid in blood.

인체 혈장 및 소변 중 에르타페넴의 정량을 위한 LC-MS/MS 분석법 검증 (Validation of LC-MS/MS method for determination of ertapenem in human plasma and urine)

  • 김윤정;한송희;전지영;황민호;임용진;채수완;김민걸
    • 분석과학
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    • 제25권1호
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    • pp.19-24
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    • 2012
  • LC-MS/MS를 이용하여 혈장과 소변 중 에르타페넴의 신속하고 정확한 분석법을 개발하고 이 분석법에 대한 검증을 수행하였다. 혈장과 소변 분석을 위하여 내부 표준 물질인 세프타지딤을 첨가한 후 메탄올로 단백질을 침전시키고, 그 상층액을 취하여 메탄올로 희석하여 LC-MS/MS로 분석하였다. MS/MS의 MRM (multiple reaction monitoring) 방법을 이용하여 혈장과 소변 중의 에르타페넴을 어떠한 분석의 방해물 없이 선택적으로 검출할 수 있었다. 혈장 중 에르타페넴의 표준 검량선은 1~100 ${\mu}g/mL$의 농도 범위에서 우수한 직선성($r^2$ = 0.9996)을 보였으며, 일내, 일간 재현성은 변동계수 8.9% 이하, 정확성은 97.2~106.2% 이었다. 또한 소변 중 에르타페넴의 분석 결과는 좋은 상관관계($r^2$ = 0.9992)를 보였고, 일내, 일간 재현성이 변동계수 7.2% 이하, 정확성이 97.9~111.6% 이었다. 결과적으로 에르타페넴의 약동학 연구에 적용되기에 충분한 감도와 특이성, 직선성, 정밀성 및 정확성을 가지고 있음을 확인하였다.

자외선 차단제의 일반 물, 인공 해수, 자연 해수의 내수성 차단지수를 비교하기 위한 시험 (A Test to Compare the Water Resistance Sun Protection Factor of General Water, Artificial Seawater, and Natural Seawater of Sunscreen)

  • 황형훈;강은영;김수영;정희정;양준성;홍원규;김홍석
    • 대한화장품학회지
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    • 제49권4호
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    • pp.349-354
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    • 2023
  • 자외선 차단제는 자외선을 차단 및 산란시켜 자외선으로부터 보호하는 제품으로 이제 화장품을 넘어서 생활필수품으로 자리 잡고 있다. 자외선 차단제 바르기는 일반적이면서도 손쉬운 자외선에 의한 피부 손상 예방법이다. 이러한 중요성에 따라 자외선 차단제 평가시험은 1978 년 Fod and Drug Administration (FDA)에서 규정을 마련한 이후, 현재는 International Organization For Standardization (ISO)에서 표준화된 방법까지 발전되었다. 더불어 물이나 땀 등 신체활동에 의한 자외선 차단제 손실을 평가하기 위해 국내 식약처와 ISO에서 내수성 자외선 차단지수 평가시험을 제정하고 있다. 그러나 지금까지의 내수성 자외선 차단지수 평가시험은 주로 일반 물을 사용한 시험 방법에 국한되어 있으며, 해변에서의 레저, 스포츠 및 여가활동에 의한 해수의 영향을 고려한 시험 방법은 아직 정립되지 않았다. 본 연구는 기존의 내수성 자외선 차단지수 평가시험 방법 가이드라인을 기반으로 일반 물, 인공 해수(소금물) 및 자연 해수(바닷물)에서의 내수성 자외선 차단지수를 비교하여 해양 레저, 스포츠 및 여가활동 등과 같은 실제 상황에서의 자외선 차단지수를 평가할 수 있는 방법에 대하여 조사하였다. 이러한 결과를 통해 일반 물과 인공 해수 및 자연 해수에서의 내수성 자외선 차단지수 평가시험의 차이를 비교하여 자연 해수를 이용한 내수성 자외선 차단지수 평가시험 방법을 제시할 수 있었다.

The effects of dietary self-monitoring intervention on anthropometric and metabolic changes via a mobile application or paper-based diary: a randomized trial

  • Taiyue Jin;Gyumin Kang;Sihan Song;Heejin Lee;Yang Chen;Sung-Eun Kim;Mal-Soon Shin;Youngja H Park;Jung Eun Lee
    • Nutrition Research and Practice
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    • 제17권6호
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    • pp.1238-1254
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    • 2023
  • BACKGROUND/OBJECTIVES: Weight loss via a mobile application (App) or a paper-based diary (Paper) may confer favorable metabolic and anthropometric changes. SUBJECTS/METHODS: A randomized parallel trial was conducted among 57 adults whose body mass indices (BMIs) were 25 kg/m2 or greater. Participants randomly assigned to either the App group (n = 30) or the Paper group (n = 27) were advised to record their foods and supplements through App or Paper during the 12-week intervention period. Relative changes of anthropometries and biomarker levels were compared between the 2 intervention groups. Untargeted metabolic profiling was identified to discriminate metabolic profiles. RESULTS: Out of the 57 participants, 54 participants completed the trial. Changes in body weight and BMI were not significantly different between the 2 groups (P = 0.11). However, body fat and low-density lipoprotein (LDL)-cholesterol levels increased in the App group but decreased in the Paper group, and the difference was statistically significant (P = 0.03 for body fat and 0.02 for LDL-cholesterol). In the metabolomics analysis, decreases in methylglyoxal and (S)-malate in pyruvate metabolism and phosphatidylcholine (lecithin) in linoleic acid metabolism from pre- to post-intervention were observed in the Paper group. CONCLUSIONS: In the 12-week randomized parallel trial of weight loss through a App or a Paper, we found no significant difference in change in BMI or weight between the App and Paper groups, but improvement in body fatness and LDL-cholesterol levels only in the Paper group under the circumstances with minimal contact by dietitians or health care providers.

자체점검 도구 개발을 위한 지적사항 및 임상연구의 품질에 작용하는 요인 분석 (Analysis of Indicated Points and Main Factors Affecting the Quality of Clinical Research for the Development of Internal Audit Tools)

  • 장혜윤;장정희;이윤진
    • 대한기관윤리심의기구협의회지
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    • 제5권1호
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    • pp.14-20
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    • 2023
  • Purpose: To obtain fundamental data on selection tools for an internal audit and develop a new guideline. We scored the indicated points from the internal audit, identified the research progress and problems that occurred, and confirmed the validity of the risk factors involved. Methods: Of the 63 internal audits conducted by Keimyung University Dongsan Hospital from 2014 to 2021, we analyzed 55 clinical trials with an inspection checklist. We excluded 8 that failed to transfer data and refused to comply with the internal audit. The statistical summary of the collected data was verified and interpreted by using frequency analysis and a chi-square test. Result: Of total 55 cases included in the internal audit, sponsor-initiated trial (SIT) was 63.6% (vs. investigator-initiated trial [IIT]), clinical trial for investigational drug was 71.0% (vs. nonclinical or clinical trial for investigational device), domestic multicenter trial was 60.0% (vs. single center or multinational multicenter trial), and trial requisition for MFDS approval was 69.1% (vs. exception for MFDS approval). The 10 areas of the clinical trial inspection checklist (reports, protection of subjects, compliance with protocols, records, management of investigational drug and/or device, delegation of duties, qualification of investigators, management of specimen, contract-agreement and approval of protocols, and preservation of recorded documents) were weighted between 2 to 5 points. The average of the total points was 16.09±13.2 and 20 clinical trials were above the average. As a result of comparing the average of the total points weighted by year, the highest score was in 2020. The 4 factors that play significant roles in determining the internal quality were (1) principal subjects that initiated the clinical trials (p=0.049), (2) type (p=0.003), (3) phase of clinical trials (p=0.024), and (4) number of registered subjects reported at the time of continuing deliberation (p=0.019). Of the 10 areas of the clinical trial inspection checklist, 'record' was the most inappropriate and insufficient. We found more indicated points; the quality of performance declined in IIT, nonclinical trials, and other clinical trials that were not in phase I1-IV4, and the study of more than 30 registered subjects at the time of continuing review. Conclusion: If an institution has an internal audit selection tool that reflects the aforementioned risk factors, it will be possible to effectively manage high-risk studies; thereby, contributing to an efficient internal audit and improving the quality of clinical trials.

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공간의 키네티시즘에 관한 연구 (A study on the space kineticism)

  • 임혜선;김주연
    • 한국실내디자인학회논문집
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    • 제30호
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    • pp.28-34
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    • 2002
  • We need to think that space is not static but dynamic because it becomes wide and narrow, newly appears and disappears by human's behavior. Generally such movement in a space is a thing of feeling and dynamic about movement. But it is extending the experience of the subject by scientific technique's development and anticipation about the feature. The practical movement is actively introduced into architecture and interior design scope and occurs a trial about this movement. By using four elements -a form, hue, movement, light- kineticism becomes visual arts united with art and science. It recovers the art's sociality and arises participation of spectators. In the environment and art field kineticism is not simple ostentation but a current trial for human's mind and sensitivility. Kineticism is four-dimensional space considered by human's experience and is related to an observer, or experiential subject of space. Now the space except human's mind feature re-illuminates kineticism, that is, the field of the formative arts in the early part of the 20th century and gets to be 'the consensus space'.

태반성 성선자극호르몬(HCG) 처리에 의한 독가시치, Siganus canaliculatus의 배란유도 (Induced Ovulation in rabbitfish, siganus canaliculatus, with Human chorionic Gonadotropin (HCG))

  • 황형규;이정의;양상근;노섬;강용진
    • 한국양식학회지
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    • 제12권3호
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    • pp.197-204
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    • 1999
  • Successful produciton of seedlings for marine fish species are highly influenced by the aquisiton of sufficient number of good-quality eggs on required time. human chorionic gonadotropin has been used to induce successful ovulation for the purpose. Rabbitfish, siganus canaliculatus, is inhabited along the coast of Cheju Province and treated valuably for raw fish and fish roasted with seasoning. Female wild-captured rabbitfish (314 to 279 g in body weigth) were injected into intraperitoneal space with human chorionic gonadotropin (HCG) of 5,00,1,000, and 1,500 IU/kg body weight during spawning season of July 14 (trial 1), and July 27 (trial 2). Test fish in trial 1 were injected two times, first on July 14 and second on July 21 with one weekinterval because of no ovulation symptoms, but just one time in trial 2. All females injected both 1,000 and 1,500 IU/kg body weight ovulated in all trials. Among 500 IU/kg injection treatments, just one female ovulated in trial 1 showing 25% of ovulation rate, but none ovulated in trial 2. Ovulation was not occurred in control goups during test period. Time to reach ovulation after injection was 172 to 270 hours in trial 1 and 77 to 132 hours in trial 2, showing shorter as spawning season approached. Generally, ovulation of smaller females were late than that of larger ones. Gonadosomatic index (GSI) and pseudo-gonadosomatic index (Pseudo-GSI) were ranged 22 to 33% and 19 to 28%, respectively. One female spawned 406,200 to 1,032,000 eggs, and obtainable eggs per 100g of body weight were calculated by 130,000 to 190,000. Spawning rates were comparatively high by 96.0 to 98.4%. Rates to reach embryo-formation and hatching were higher in 500 high by 96.0 to 98.4%. Rates to reach embryo-formation and hatching were higher in 500 and 1,000 IU/kg treatments than in 1,500 IU/kg treatment. The result of present study demontrates that HCG treatment during spawning season could become very useful for ovulation of rabbitfish and the suitable dosage was suggested as 1,000 IU/kg of body weight.

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패전 후 일본의 문예재판과 평화헌법 - '채털리 재판'의 의의 - (Japanese Postwar Literary Trial and Pacific Constitution of Japan: Significance of 'Chatterley Trial')

  • 김정희
    • 비교문화연구
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    • 제47권
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    • pp.27-51
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    • 2017
  • 본고는 패전 후 일본의 대표적인 문예재판인 '채털리 재판'을 중심으로 평화헌법(신헌법)이 보장하는 인권을 사수하려고 하는 변호인 측과 검찰 사법권으로 대표되는 공권력과의 대립을 판결문을 중심으로 고찰한 것이다. 판결문을 통해서 드러나는 재판소의 외설문서의 판단기준은 '성행위의 비밀성'과 '사회통념'인데, 이들을 판단할 때 재판소는 편파적이고 애매한 기준을 부여하고 있다. 또한 재판소는 이 작품의 예술성과 외설성에 대해서 양자는 전혀 다른 차원의 것임을 인정하면서도 예술성을 공공의 복지를 기준으로 공권력인 재판소가 판단해야 한다고 주장한다. 이에 대항하여 변호인 측은 평화헌법이 보장한 표현의 자유는 무제한적이며, 중요한 것은 작품의 내용이 비인도덕인지 아닌지 라고 역설하였다. 이러한 변호인 측의 주장은 패전 이전의 상황을 연상시키는 공권력에 맞선 것으로, 단지 풍속 단속에 대해서 항의하는 차원이 아닌 과거의 일본을 재현하지 않으려고 한 투쟁이었다고 할 수 있다.

결혼이민여성의 직업교육훈련 및 취업관련 시행계획의 비판적 검토 (Critical reviews of job training and employment support trial plans for immigrant women by marriage)

  • 성향숙
    • 한국산학기술학회논문지
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    • 제14권12호
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    • pp.6186-6195
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    • 2013
  • 본 연구의 목적은 현재 우리나라 결혼이민여성의 직업교육훈련과 취업지원에 관한 시행계획을 분석하여 분석결과를 도출함으로서 차기에 수립될 관련 계획과 시행계획의 수립과정과 내용에 반영되어야할 방향성을 제시하고자 하였다. 이를 위하여 건강가정기본계획, 다문화가족정책기본계획, 경력단절 여성 등의 경제활동촉진 기본계획에 제시된 직업교육훈련 시행계획을 분석대상으로 하였다. 분석방법은 닐 길버트와 폴테릴의 정책분석 방법론을 사용하였고, 분석결과는 첫째, 내일배움카드 취업성공패키지 특화과정의 미성숙 둘째, 인적자원개발시스템의 미흡 셋째, 정부 부처간 거버넌스의 미흡을 밝히고 이러한 결과를 토대로 제언을 하였다.

A STUDY ON THE DEVELOPMENT OF AN INTERPRETER FOR MAPPING HUMAN SENSIBILITY AND DESIGN PARAMETERS ON AUTOMOTIVE INTERIOR

  • Kang, Seon-Mo;Paik, Seung-Youl;Park, Peom
    • 한국감성과학회:학술대회논문집
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    • 한국감성과학회 1999년도 추계학술대회 논문집
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    • pp.31-31
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    • 1999
  • In the preliminary design stage of an automotive interior, human sensibility is first analyzed and applied to design parameters for satisfying consumers needs using optimization and engineering judgement. Then designers try to design components that meet these needs using empirical and trial-and-error procedures. This process usually yields poor results because it is difficult to find a feasible design that satisfies the targets by trial-and-error (a feasible design is one that satisfies consumers needs and design constraints). To improve this process, we need tools to link the human sensibility with the design parameters that define the geometry of the components of an automotive interior. A methodology is presented for developing a tool for design guidance of an automotive interior. This tool translates the human sensibility into the design parameters that define the geometry of the components of an automotive interior. This tool, called interpreter, rapidly predicts the human sensibility of a given automotive interior and presents design parameters that meet or exceed given human sensibility to satisfy consumers needs and design constraints. The methodology is demonstrated on the interior design of an actual automotive.

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