• Title/Summary/Keyword: human trial

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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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    • v.33 no.5
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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.

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

  • Kim, Yun-Jeong;Han, Song-Hee;Jeon, Ji-Young;Hwang, Min-Ho;Im, Yong-Jin;Chae, Soo-Wan;Kim, Min-Gul
    • Analytical Science and Technology
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    • v.25 no.1
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    • pp.19-24
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    • 2012
  • Liquid chromatography-tandem mass spectrometry (LC-MS/MS) method has been developed and validated for the quantitative determination of ertapenem in human plasma and urine. After addition of internal standard (ceftazidime), plasma and urine was diluted with methanol and analyzed by LC-MS/MS. Using MS/MS with multiple reaction monitoring (MRM) mode, ertapenem were selectively detected without severeinterference from human plasma and urine. The standard calibration curve for ertapenem was linear ($r^2$= 0.9996)over the concentration range 1~100 ${\mu}g/mL$ in human plasma. The intra- and inter-day precision over the concentration range of ertapenem was lower than 8.9% (correlation of variance, CV), and accuracy was between 97.2~106.2%. On the other hand, it was showed good relationship ($r^2$= 0.9992) and the precision (intra- and inter-day) over the concentration range of ertapenem was lower than CV 7.2%, and accuracy was between 97.9~111.6% for urine. This method has been successfully applied to the pharmacokinetic study of ertapenem in human plasma and urine.

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

  • Hyoung Hoon Hwang;Eun Young Kang;Su Yeong Kim;Hui Jeong Jung;Jun Seong Yang;Won Kyu Hong;Hong Suk Kim
    • Journal of the Society of Cosmetic Scientists of Korea
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    • v.49 no.4
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    • pp.349-354
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    • 2023
  • Sunscreen is a product that protects against ultraviolet rays by blocking and scattering ultraviolet rays, and has now become a daily necessity beyond cosmetics. Applying sunscreen is a common and easy way to prevent skin damage caused by ultraviolet rays. Due to its significance, the evaluation of sunscreen has evolved since its regulation by the FDA in 1978, progressing to standardized methods established by ISO. Additionally, to assess the loss of sunscreen due to activities such as water exposure or sweating, the Ministry of Food and Drug Safety in Korea and ISO have established protocols for evaluating the water-resistant sun protection factor (SPF). However, existing evaluations of water resistance have been mainly confined to test methods involving plain water, and methods accounting for the impact of seawater during activities like beach leisure, sports, and recreation are yet to be established. Based on the existing guidelines for testing the water-resistant UV protection index, this study compared the water-resistant UV protection index in water, artificial seawater (salt water) and natural seawater (sea water) to evaluate the UV protection index in real-world situations such as marine leisure, sports, and leisure activities. Through these results, we were able to compare the differences between water resistance sun protection index tests in ordinary water, artificial seawater, and natural seawater, and suggest a method for water resistance sun protection index tests using natural seawater.

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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    • v.17 no.6
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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.

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

  • Hye Yun Jang;Jung-Hee Jang;Yoon Jin Lee
    • The Journal of KAIRB
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    • v.5 no.1
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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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A study on the space kineticism (공간의 키네티시즘에 관한 연구)

  • 임혜선;김주연
    • Korean Institute of Interior Design Journal
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    • no.30
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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'.

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

  • Hwang, Hyung-Kyu;Lee, Jung-Uie;Yang, Sang-Geun;Rho, Sum;Kang, Yong-Jin
    • Journal of Aquaculture
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    • v.12 no.3
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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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Japanese Postwar Literary Trial and Pacific Constitution of Japan: Significance of 'Chatterley Trial' (패전 후 일본의 문예재판과 평화헌법 - '채털리 재판'의 의의 -)

  • Kim, Junghee
    • Cross-Cultural Studies
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    • v.47
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    • pp.27-51
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    • 2017
  • This paper considers opposition between lawyers to defend human rights which the Pacific Constitution of Japan guarantees and the public power represented by the prosecution's judicial power centered on sentencing in the 'Chatterley Trial' that was a Japanese representative literary trial which occurred after World War II. The lawyers' assertion is against the public power which reminds us of the Press Act before the war defeat. Although censorship is banned in the constitution, and it can be said that it is not a dimension just to protest the check of custom but the struggle not to reenact the past Japan.

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

  • Seong, Hyang-Sook
    • Journal of the Korea Academia-Industrial cooperation Society
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    • v.14 no.12
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    • pp.6186-6195
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    • 2013
  • The aim of this study was to learn what directions need to be reflected when establishing the next-term trial plans by analyzing the current trial plans being implemented in Korea regarding job training and employment support for immigrant women by marriage. For this purpose, the job training suggested in the Healthy Family Basic Plan and Multicultural Family Policy Basic Plan as well as in the Basic Economic Activity Stimulation Plans for Out-of-employment Women were analyzed. Based on this, job training was reconstructed into four categories: 1) education and training program; 2) human resource development; 3) employment support; and 4) delivery system. For the analysis, the policy analysis methods reported by N. Gilbert and P.Terrile were used. The results showed that the current trial plans exhibited immaturity in the Tomorrow Learning Card and Successful Employment Package as well as in the specialization process, lack of a human resource development system, and the absence of governance. Several proposals should consider these when making the next-term trial plans.

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
    • Proceedings of the Korean Society for Emotion and Sensibility Conference
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    • 1999.11a
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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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