• Title/Summary/Keyword: Human trials

Search Result 395, Processing Time 0.025 seconds

Trends of Innovative Clinical Drug Development using AMS (Accelerator Mass Spectrometry) and $^{14}C$-micro Tracer (가속질량분석기(Accelerator mass spectrometry, AMS)와 극미량 $^{14}C$-동위원소를 이용한 혁신적 임상시험개발동향)

  • Cho, Kyung Hee;Lee, Hee Joo;Choie, Hyung Sik;Lee, Kyoung Ryul;Dueker, Stephen R.;Shin, Young G.
    • YAKHAK HOEJI
    • /
    • v.57 no.6
    • /
    • pp.412-419
    • /
    • 2013
  • Drug discovery and development processes are time consuming and costly endeavors. It has been reported that on average it takes 10 to 15 years and costs more than $ 1billion to bring a molecule from discovery to market. Compounds fail for various reasons but one of the significant reasons that accounts for failures in clinical trials is poor prediction/understanding of pharmacokinetics and drug metabolism in human. In an effort to improve the number of compounds that exhibit optimal absorption, distribution, metabolism, elimination (ADME), and pharmacokinetic properties in human, drug metabolism, pharmacokinetic scientists have been continually developing new technologies and compound screening strategies. Over the last few years, accelerator mass spectrometry (AMS) and its applications to preclinical/clinical pharmacokinetics and ADME studies have significantly increased, particularly for new chemical/biological entities that are difficult to support with conventional radiolabel studies. In this review, the application of AMS for micro-dosing, micro-tracer absolute bioavailability, mass balance and metabolite profiling studies will be discussed.

The Effects of Season on Physiological Responses of Human Body, Clothing Microclimate, and Subjective Sensations (인체의 생리적 반응과 의복 기후, 주관적 감각에 미친 계절의 영향)

  • 김양원
    • Journal of the Korean Home Economics Association
    • /
    • v.30 no.4
    • /
    • pp.15-26
    • /
    • 1992
  • To investigate the seasonal effects on physiological responses of human body, clothing micro-climate, and subjective sensation, selected the cloths the most frequently dressed by men in spring and fall, and completed wearing trials in the climatic chamber. The results are as follows: 1. Rectal temp. ranged 36.8-37.1$^{\circ}C$ in either spring or fall, and no seasonal effect was found. 2. In skin temp., there was no seasonal effect in forehead, abdomen, and forearm. Skin temp. of chest was higher in spring than in fall. On the contrary, reverse was true in high and leg. Average skin temp. ranged 32.2-33.2$^{\circ}C$ in spring and 32.9-34.$0^{\circ}C$ in fall. 3. Average total sweat rate of spring, 79.4g/hr, was smaller than that of fall, 110.9g/hr. 4. Clothing temp. ranged 28.1-32.8$^{\circ}C$ in spring and 27.6-31.$0^{\circ}C$ in fall. Clothing humidity ranged 36.9-48.9% in spring and 38.2-51.1% in fall. Therefore, clothing microclimate was higher during fall than during spring. As results, skin temp. of the body core except chest did not show seasonal variation, but there was obvious seasonal variation in skin temp. of the extremities. Therefore, seasonal variation should be take into consideration in the experiments related to the cloth. In addition, standard for each season and the degree of work performance should be re-established in clothing micro-climate.

  • PDF

A Robotic System with Behavioral Intervention facilitating Eye Contact and Facial Emotion Recognition of Children with Autism Spectrum Disorders (자폐 범주성 장애 아동의 눈맞춤과 얼굴표정읽기 기능향상을 위한 행동 중재용 로봇시스템)

  • Yun, Sang-Seok;Kim, Hyuksoo;Choi, JongSuk;Park, Sung-Kee
    • The Journal of Korea Robotics Society
    • /
    • v.10 no.2
    • /
    • pp.61-69
    • /
    • 2015
  • In this paper, we propose and examine the feasibility of the robot-assisted behavioral intervention system so as to strengthen positive response of the children with autism spectrum disorder (ASD) for learning social skills. Based on well-known behavioral treatment protocols, the robot offers therapeutic training elements of eye contact and emotion reading respectively in child-robot interaction, and it subsequently accomplishes pre-allocated meaningful acts by estimating the level of children's reactivity from reliable recognition modules, as a coping strategy. Furthermore, for the purpose of labor saving and attracting children's interest, we implemented the robotic stimulation configuration with semi-autonomous actions capable of inducing intimacy and tension to children in instructional trials. From these configurations, by evaluating the ability of recognizing human activity as well as by showing improved reactivity for social training, we verified that the proposed system has some positive effects on social development, targeted for preschoolers who have a high functioning level.

Glucagon-like peptide-1 and glucagon-like peptide-1 receptor agonists in the treatment of type 2 diabetes

  • Lee, Seungah;Lee, Dong Yun
    • Annals of Pediatric Endocrinology and Metabolism
    • /
    • v.22 no.1
    • /
    • pp.15-26
    • /
    • 2017
  • The prevalence of type 2 diabetes (T2D) is increasing worldwide. Patients with T2D suffer from various diabetes-related complications. Since there are many patients with T2D that cannot be controlled by previously developed drugs, it has been necessary to develop new drugs, one of which is a glucagon-like peptide-1 (GLP-1) based therapy. GLP-1 has been shown to ameliorate diabetes-related conditions by augmenting pancreatic ${\beta}-cell$ insulin secretion and having the low risk of causing hypoglycemia. Because of a very short half-life of GLP-1, many researches have been focused on the development of GLP-1 receptor (GLP-1R) agonists with long half-lives such as exenatide and dulaglutide. Now GLP-1R agonists have a variety of dosing-cycle forms to meet the needs of various patients. In this article, we review the physiological features of GLP-1, the effects of GLP-1 on T2D, the features of several GLP-1R agonists, and the therapeutic effect on T2D.

Online-Effects of Transcranial Direct Current Stimulation on Bimanual Force Control Performances in Healthy Young Adults (실시간 비침습적 뇌전기 자극이 양손 힘 조절능력에 미치는 영향)

  • Tae Lee, Lee;Joon Ho, Lee;Nyeonju, Kang
    • Korean Journal of Applied Biomechanics
    • /
    • v.32 no.4
    • /
    • pp.121-127
    • /
    • 2022
  • Objective: The purpose of this study was to investigate potential effects of transcranial direct current stimulation (tDCS) on bimanual force control capabilities in healthy young adults. Method: Eighteen right-handed healthy young adults (10 females and 8 males; age: 23.55 ± 3.56 yrs) participated in this crossover design study. All participants were randomly allocated to both active-tDCS and sham-tDCS conditions, respectively. While receiving 20 min of active- or sham-tDCS interventions, all participants performed bimanual isometric force control tasks at four submaximal targeted force levels (i.e., 5%, 10%, 15, and 20% of maximal voluntary contraction: MVC). To compare bimanual force control capabilities including force accuracy, variability, and regularity between active-tDCS and sham-tDCS conditions, we conducted two-way repeated measures ANOVAs (2 × 4; tDCS condition × Force levels). Results: We found no significant difference in baseline MVC between active-tDCS and sham-tDCS conditions. Moreover, our findings revealed that providing bilateral tDCS including anodal tDCS on left primary motor cortex (M1) and cathodal on right M1 while conducting bimanual force control trials significantly decreased force variability and regularity at 5%MVC. Conclusion: These findings suggest that providing bilateral tDCS on M1 areas may improve bimanual force control capabilities at a relatively low targeted force level.

Classification of NOVCs and AVOCS for Healing Substance Measurement System Based on Gas Sensors Array in Forest Environment (가스센서 어레이를 이용한 산림환경 내 치유물질 측정시스템을 통한 자연적 휘발성 유기화합물(NVOCs)과 인위적 휘발성 유기화합물(AVOCs) 분류)

  • Joon-Boo Yu;Hyung-Gi Byun
    • Journal of Sensor Science and Technology
    • /
    • v.32 no.2
    • /
    • pp.95-99
    • /
    • 2023
  • Forest healing is an activity that enhances immunity and human health using various elements of nature, such as fragrance and scenery. Particularly, phytoncide composed of terpene, a natural volatile substance emitted by forest plants, activates the immune function and is an important raw material in health-related products, such as antibacterial and insect repellents. Moreover, phytoncide is used as a measure to evaluate the impact of the forest atmosphere on the human body. This study aims to implement a highly sensitive gas sensor system that can measure phytoncide in real-time, which is an essential element for realizing a forest healing environment. A gas generation apparatus was implemented by using an adsorption tube in consideration of filed applicability in a laboratory atmosphere to enable the measurement of α-pinene and limonene, which are among the main components of phytoncide. Throughout the experimental trials, the sensitivity of gas sensor arrays to α-pinene and limonene was confirmed. In addition, the classification results demonstrated the AVOCs and NVOCs can be well discriminated using PCA. The primary results confirmed the possibility of developing a high-sensitivity gas sensor system for phytoncide sensing in real time.

Non-invasive evaluation of embryo quality for the selection of transferable embryos in human in vitro fertilization-embryo transfer

  • Jihyun Kim;Jaewang Lee;Jin Hyun Jun
    • Clinical and Experimental Reproductive Medicine
    • /
    • v.49 no.4
    • /
    • pp.225-238
    • /
    • 2022
  • The ultimate goal of human assisted reproductive technology is to achieve a healthy pregnancy and birth, ideally from the selection and transfer of a single competent embryo. Recently, techniques for efficiently evaluating the state and quality of preimplantation embryos using time-lapse imaging systems have been applied. Artificial intelligence programs based on deep learning technology and big data analysis of time-lapse monitoring system during in vitro culture of preimplantation embryos have also been rapidly developed. In addition, several molecular markers of the secretome have been successfully analyzed in spent embryo culture media, which could easily be obtained during in vitro embryo culture. It is also possible to analyze small amounts of cell-free nucleic acids, mitochondrial nucleic acids, miRNA, and long non-coding RNA derived from embryos using real-time polymerase chain reaction (PCR) or digital PCR, as well as next-generation sequencing. Various efforts are being made to use non-invasive evaluation of embryo quality (NiEEQ) to select the embryo with the best developmental competence. However, each NiEEQ method has some limitations that should be evaluated case by case. Therefore, an integrated analysis strategy fusing several NiEEQ methods should be urgently developed and confirmed by proper clinical trials.

Vaccines development in India: advances, regulation, and challenges

  • Rakshita Salalli;Jyoti Ram Dange;Sonia Dhiman;Teenu Sharma
    • Clinical and Experimental Vaccine Research
    • /
    • v.12 no.3
    • /
    • pp.193-208
    • /
    • 2023
  • One of the most significant medical advancements in human history is the development of vaccines. Progress in vaccine development has always been greatly influenced by scientific human innovation. The main objective of vaccine development would be to acquire sufficient evidence of vaccine effectiveness, immunogenicity, safety, and/or quality to support requests for marketing approval. Vaccines are biological products that enhance the body's defenses against infectious diseases. From the first smallpox vaccine to the latest notable coronavirus disease 2019 nasal vaccine, India has come a long way. The development of numerous vaccines, driven by scientific innovation and advancement, combined with researcher's knowledge, has helped to reduce the global burden of disease and mortality rates. The Drugs and Cosmetics Rules of 1945 and the New Drugs and Clinical Trials Rules of 2019 specify the requirements and guidelines for CMC (chemistry, manufacturing, and controls) for all manufactured and imported vaccines, including those against coronavirus infections. This article provides an overview of the regulation pertaining to the development process, registration, and approval procedures for vaccines, particularly in India, along with their brief history.

A Review of Recent Domestic Research on Herbal Medicine Treatments for Ulcerative Colitis: A Focus on OASIS Platform Research (궤양성 대장염의 한약치료에 대한 국내 연구동향 분석 - 오아시스 검색을 중심으로)

  • Sae-rom Choi;Ji-yoon Lee;Sang-min Park;Jae-wook Shin;Jee-hoon Baek;Min-ju Lee;Eun-jee Lee
    • The Journal of Internal Korean Medicine
    • /
    • v.44 no.6
    • /
    • pp.1256-1270
    • /
    • 2023
  • Objectives: This study analyzes domestic research trends on herbal medicine treatments for ulcerative colitis (UC) by examining 28 selected domestic papers using the Oriental Medicine Advanced Searching System (OASIS) as the main search source. Methods: A total of 28 domestic papers were selected on the OASIS platform as the main search source using the keywords "(궤양성 대장염) or (궤양성 대장병)" and "(한약) or (한의학)". Results: There were 11 case report studies and 17 case-control studies published from 2002 to 2022. All the case-control studies only dealt with mice and did not include human subjects. The most common pathologies were damp heat and Changpung. Hwangryunhaedok-tang was the most frequently prescribed herbal formula, and Coptidis Rhizoma was the most commonly used herb across all studies. The results showed that many studies demonstrated the significant effects of herbal treatment. Conclusion: Herbal medicine may exhibit therapeutic effects on various aspects of UC. However, evidence-based studies, such as clinical trials involving human subjects, are needed.

Study on Space Interaction Design of Media Art in Architecture Facade - Focused on Case of Using Projection Mapping Techniques - (건물 파사드 미디어아트의 공간 인터랙션 디자인에 관한 연구 - 프로젝션 매핑(Projection Mapping) 기법을 사용한 사례를 중심으로 -)

  • Kim, Eun Soo;Kim, Kai Chun
    • Korean Institute of Interior Design Journal
    • /
    • v.23 no.2
    • /
    • pp.117-124
    • /
    • 2014
  • As the contemporary times entered, the attention focused on the 'human's perception on a space' as much as on that a space's physical structure, so the meaning of a space became defined depending on how a person thought over and behaved in the space. As this age is the times of consilience and integration, a space accepts new technologies beyond being defined simply based on the space's structure and its shape and tries to provide different, 'strange experiences' from tho se felt by the human until now. Recently in the filed of space design, it can be seen that the spae design's connection with various technologies affects on considerable influence on the all fields of culture and arts like space marketings, media arts, exhibitions and performances as well as the buildings. Especially. the fusion of digital images and architecture is actively developed. Images possessing the moving light's attributes shine a city night and day and a building changes a city's appearance itself by adding new materials on the surface of building. It is the purpose of this study to study what new experiences the human gets and creates from his interaction with spaces based on such technological fusion. By studying some cases that used the digital media as a mediating instrument as the way presenting spatial experiences to the human, this study intended to identify what design factors were applied and to find appropriate directions for space desig in relation to what new trials can be done.