• Journal of Acupuncture Research
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• v.20 no.2
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• pp.18-28
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• 2003

Objective : To research the trends of study related to osteoarthritis with acupuncture in PubMed, and to establish he hereafter direction of acupuncture for osteoarthritis. Methods : We searthed in PubMed, with osteoarthritis and acupuncture limited by abstract, human, English. Results : 1. The pattern of study was as follow: Review article(2), Clinical Trials(13), randomized controlled trials(13). bee venom acupuncture(1), electroacupuncture(1). We further estimated 15 articles. 2. The lesion of osteoarthritis & kinds of acupuncture were as follows: knee(12), hip(2), cervical vertebral(1), bee venom acupuncture(1), electroacupuncture(1). 3. Most clinical trials are related to decrease of pain, functional improvement. 4. 10 of clinical studies provide affirmative result. And they recommend acupuncture for osteoarthritis. 5. 4 of clinical studies provide negative result. And these studies are designed by sham acupuncture method.

• Journal of Ginseng Research
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• v.43 no.3
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• pp.361-367
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• 2019

Panax ginseng, known as Koran ginseng, one of the most commonly used traditional plants, has been demonstrated to show a wide range of pharmacological applications. Ginsenosides are the major active ingredients found in ginseng and are responsible for the biological and pharmacological activities, such as antioxidation, antiinflammation, vasorelaxation, and anticancer actions. Existing studies have mostly focused on identifying and purifying single ginsenosides and investigating pharmacological activities and molecular mechanisms in cells and animal models. However, ginsenoside studies based on clinical trials have been very limited. Therefore, this review aimed to discuss the currently available clinical trials on ginsenosides and provide insights and future directions for developing ginsenosides as efficacious and safe drugs for human disease.

• Korean Journal of Clinical Pharmacy
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• v.26 no.2
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• pp.150-162
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• 2016

Objective: First-in-human dose estimation is an essential approach for successful clinical trials for drug development. In this study, we systematically compared first-in-human dose and human pharmacokinetic parameter estimation approaches. Methods: First-in-human dose estimation approaches divided into similar drug comparison approaches, regulatory guidance based approaches, and pharmacokinetic based approaches. Human clearance, volume of distribution and bioavailability were classified for human pharmacokinetic parameter estimation approaches. Results: Similar drug comparison approaches is simple and appropriate me-too drug. Regulatory guidance based approaches is recommended from US Food and Drug Administration (FDA) and European Medicines Agency (EMA) regarding no-observed-adverse-effect level (NOAEL) or minimum anticipated biological effect level (MABEL). Pharmacokinetic based approaches are 8 approaches for human clearance estimation, 5 approaches for human volume of distribution, and 4 approaches for human bioavailability. Conclusion: This study introduced and compared all methods for first-in-human dose estimation. It would be useful practically to estimate first-in-human dose for drug development.

• Korean Journal of Applied Biomechanics
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• v.17 no.4
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• pp.115-125
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• 2007

Grould Reaction force(GRF) is important in human movements and GRF measurements are one of the most frequently used tool in biomechanical studies. In the studies of the golf swing motion, people refer to GRF as weight transfer. A successful golf swing motion requires many segments activation sequences which are controled by the nerve system. Due to the inter- and intra-individual variability of the human movement and the movement strategies, reliability of the measurements are important in human movement studies. Previous golf researches were based on group studies and certain events' values were analyzed. The purposes of this study were to determine the number of trials for the reliable golf swing GRF data collection, to reveal the variability level of the meaningful components of the golf swing GRF, and to classify the types of the golf swing GRF patterns. Twenty three male professional golfers($26.4{\pm}6.6$ years, $174.3{\pm}5.2\;cm$, $71.3{\pm}6.5\;kg$) signed an informed consent form prior to participation in this study. GRFs of driver swings were collected with Kistler 9285 force platform and 9865A amplifier, and calculated by the KwonGRF program(Visol, Korea). Sampling frequency was 1080 Hz. GRF data were trimmed from 1.5 s prior to the impact to 0.5 s after the impact. The number of trials for the reliable GRF collection was determined when the change in floating mean overs the 25 % of the standard deviation of that variable. Variabilities of the variables were determined by the coefficient of variation(CV) of 10 %. The types of GRF patterns were determined by visual inspection of the peak GRF shapes. The minimum number of trials for the reliable golf swing GRF data collection was five. Ten-trial seems more conservative. The value of the peak GRF was more reliable than the value of the impact GRF. The CV of the peak GRF and impact GRF were 7.4 %, 15.2 %, respectively. Because of the +/- sigh of the peak GRF appearance time, it was impossible to calculate CV of the peak GRF appearance time. Golf swing GRF patterns were classified as sing peak type, double peak type, and plateau peak type. This classification suggests the presence of the different golf swing weight transfer strategies.

• Proceedings of the Korean Society of Applied Pharmacology
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• 1997.11a
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• pp.35-39
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• 1997

Recent development of human genetics and techniques of gene transfer and expression have opened the way for investigating novel approaches based on the genetic modification of cells to treat both inherited and acquired diseases. This approach is referred to as gene therapy. Over the past few years, gene therapy has moved from the laboratory to phase I clinical trials. Although the clinical performance of gene transfer experiments is still in an early phase of development, the NIH of Health Recombinant DNA Advisory Comittee (RAC) has approved more than 150 protocols that involve gene transfer or putative gene therapy procedures in clinical settings. Many sectors of society in United States have participated in the design and formulation of these clinical trials through local Institutional Review Boards, the National Institutes of Health (NIH) RAC, the Chemotherapy Evaluation Program of the National Cancer institute, and the FDA. Currently, clinical trials involving gene modification are under way at many medical centers throughout the United Slates. The goals of these trials are as follows. (1) The design should be directed to short-term achievable goals. (2) Each clinical trial is best considered as an intermediate step in a multistep process. (3) The design should identify evaluable proximate endpoints for toxicity and for efficacy, (4) The potential benefits and possible risks for patients participating in these trial should be defined.

• Quality Improvement in Health Care
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• v.2 no.1
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• pp.86-109
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• 1995

Clinical trials of drugs on humans is the final and most important stage in evaluating the safety and efficacy of the drugs. Good Clinical Practice(GCP) standards were announced in 1987 to protect testees' rights as well as to ensure validity of the clinical trial results, but its implementation has been delayed until now. The purpose of this study is to evaluate the preparedness of the designated institutions to abide by GCP standards during clinical trials, and thereby to determine GCP implementability at the institutions. Survey on the status of clinical trials was conducted for the designated 83 clinical trial hospitals. Response rate was 95.2%. Donabedian's quality assessment model was applied as the basic framework for the study. And the relative - weights for the evaluation items were determined by expert's evaluation. Among the designated 83 hospitals, 39 conducted clinical trials to obtain drug manufacturing approval from 1990 to 1994. Only 19 institutions are found to be able to meet the requirements of KGCP. Structure variables - manpower, organization, and facility -, which are the basic elements for GCP, are evaluated as unsatisfied in many hospitals. Institutions which established IRB accounted for 41 or 51.9%, but those who have a protocol evaluation guideline, or Adverse Drug Reaction(ADR) reporting system were only 12 and 21 institutions, respectively. Also, the institutions providing educational programs on conducting clinical trials are few - 20. The study results indicates that the level of conducting KGCP is unsatisfactory. However, more institutions are expected to be able to meet the standards soon because GCP standards does not require so much regulation on facilities, but stress importance on research methodology and human right. At present as the institutions for clinical trials are primarily training hospitals with residency programs, such efforts as education will accelerate the implementability of GCP in Korea. Institutions must build the appropriate infrastructure and government must prepare to strongly enforce KGCP before it can successfully take place.

• Journal of Korean Medicine Rehabilitation
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• v.19 no.3
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• pp.33-46
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• 2009

Objectives : The objective of the study was to summarize randomized clinical trials(RCTs) that have assessed the effectiveness of herbal medicine on treatment of obesity and to propose better process of study. Methods : NLM Medline(pubmed), EMBASE, the Cochrane library, Science Direct, EBSCO, 4 Korean medical databases were systematically searched and 4 Korean medical journals were manually searched for clinical trials investigating the efficacy of herbal medicines on treatment of overweight or obese people from 1998 to 2008. The methodological quality was assessed using a Jadad score and validity was assessed using Oxford Pain Validity Scale(OPVS). Results : 14 RCTs met all the inclusion criteria. The methodological and ethical quality of the trials was generally low. The mean score by Jadad was 2.6 and the mean score of validity was 11.2. Complex herbal medicine was used in 8 RCTs and single herbal medicine was used in 6 RCTs. Except 1 RCT, the other RCTs reported positive effects of herbal medicine on treatment of obesity. Herbal medicines didn't seem to affect toxicity. In general adverse events relevant with the therapy were minor, but more than half of RCTs did not report about the safety or adverse events of herbal medicine, questioning their reliability. Conclusions : Although most RCTs concluded the efficacy and safety of herbal medicines on treatment of obesity, the quality of trials was low in general. Further rigorous clinical trials using complex herbal medicine should be performed.

• The Journal of KAIRB
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• v.4 no.2
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• pp.36-41
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• 2022

Purpose: The purpose of this study is to evaluate how university hospital Institutional Review Boards (IRBs) in Korea classify risk when reviewing clinical trial protocols. Methods: IRB experts (IRB chairman, vice chairman, IRB administrator) in the university hospitals obtaining a Human research protection program (HRPP) or IRB accreditation in Korea were asked to fill out the Google Survey from September 1, 2020 to October 10, 2020. Result: Among the 23 responder hospitals, 8 were accredited by the American Association for Human Research Protection Program (AAHRPP) and 8 were accredited by the HRPP of Ministry of Food and Drug Safety (MFDS). Seven were accredited by Forum for Ethical Review Committees in Asia and the Western Pacific or Korea National Institution for Bioethics Policy. Thirteen of 23 hospitals (56.5%) had 4 levels (less than minimal, low, moderate, high risk), 4 hospitals had 3 levels (less than, slightly over, over than minimal risk), 1 hospital had 5 levels (4 levels plus required data safety monitoring board), and 1 hospital had 2 levels (less than, over than minimal risk) risk classification system. Thirteen of 23 hospitals (56.5%) had difficulty classifying the risk levels of research protocols. Fourteen hospitals (60.9%) responded that different standards among hospitals for risk level determination associated with clinical trials will affect the subject protection. Six hospitals (26.1%) responded that it will not. Three hospitals (13.0%) responded that it will affect the beginning of the clinical trial. To resolve differences in standards between hospitals, 14 hospitals (60.9%) responded that either the Korean Association of IRB or MFDS needs to provide a guideline for risk level determination in clinical trials: 5 hospitals (21.7%) responded education for IRB members and researchers is needed; 3 hospitals (13.0%) responded that difference among institutions needs to be acknowledged; and 1 hospital (4.3%) responded that there needs to be communication among IRB, investigator, and sponsor. Conclusion: After conducting a nationwide survey on how IRB in university hospital determines risk during review of clinical trials, it is reasonable to use 4-level risk classification (less than minimal, low, moderate, high risk); the most utilized method among hospitals. Moreover, personal information and conflict of interest associated with clinical trials have to be considered when reviewing clinical trial protocols.

• IMMUNE NETWORK
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• v.1 no.1
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• pp.7-13
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• 2001

Currently 18 monoclonal antibodies were approved by FDA for inj ection into humans for therapeutic or diagnostic purpose. And 146 clinical trials are under way to evaluate the efficacy of monoclonal antibodies as anti-cancer agents, which comprise 9 % of clinical trials in cancer therapy field. When considering a lot of disappointment and worries existed in this field during the past 15 years, this boom could be called as resurrection. Antibodies have several merits over small molecule drug. First of all it is easier and faster in development, as proper immunization of the target proteins usually raises good antibody response. The side effects of antibodies are more likely to be checked out in immunohistomchemical staining of whole human tissues. Antibody has better pharmacokinetics, which means a longer half-life. And it is non-toxic as it is purely a "natural drug. Vast array of methods was developed to get the recombinant antibodies to be used as drug. The mice with human immunoglobulin genes were generated. Fully human antibodies can be developed in fast and easy way from these mice through immunization. These mice could make even human monoclonal antibodies against any human antigen like albumin. The concept of combinatorial library was also actively adopted for this purpose. Specific antibodies can be screened out from phage, mRNA, ribosomal library displaying recombinant antibodies like single chain Fvs or Fabs. Then the coding genes of these specific antibodies are obtained from the selected protein-gene units, and used for industrial scale production. Both $na\ddot{i}ve$ and immunized libraries are proved to be effective for this purpose. In post-map arena, antibodies are receiving another spotlight as molecular probes against numerous targets screened out from functional genomics or proteomics. Actually many of these antibodies used for this purpose are already human ones. Through alliance of these two actively growing research areas, antibody would play a central role in target discovery and drug development.

• Korean Journal of Veterinary Research
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• v.58 no.1
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• pp.33-37
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• 2018

Various trials have been conducted to develop therapies for serious untreatable diseases. Among these, those using stem cells have shown great promise, and adipose-derived mesenchymal stem cells (ADMSCs) are easier to obtain than other types of stem cells. Prior to clinical trials, characterization of ADMSCs with monoclonal antibodies should be performed. However, it is difficult to use species-specific antibodies for veterinarians. This study was conducted to confirm the panel of human antibodies applicable for use in immunophenotypic characterization of canine adipose-derived stem cells and feline ADMSCs extracted from subcutaneous adipose tissue collected during ovariohysterectomy. For flow cytometric immunophenotyping, the third passages of canine ADMSC and feline ADMSC and human CD31, CD34, CD42, CD44, CD62 and CD133 antibodies were used. Of these, CD133 reacted with canine cells (3.74%) and feline cells (1.34%). CD133 is known as a marker related with more primitive stem cell phenotype than other CD series. Because this human CD133 was not a species-specific antibody, accurate percentages of immunoreactivity were not confirmed. Nevertheless, the results of this study confirmed human CD133 as a meaningful marker in canine and feline ADMSCs.