• 의료법학
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• 제13권2호
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• pp.79-113
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• 2012

This study focuses on the protection of trial subjects, who participate in clinical trials for new drug. It takes long time to develop new drugs and the clinical trials are required. Usually, pharmaceutical company, which develop new drug, request a research institution(usually, hospital) to investigate the examination of security and side effects of new drug. The institution recruit trial subject to participate in the trials. The contract for clinical research of investigational new drug is concluded between the pharmaceutical company and the institution. This thesis studies the legal regulations for protection of participants of clinical research for new drug. In this respect the first matter of this study is to seek which relation between pharmaceutical firm and participants of clinical trials. Especially, there is a question which the trial subject is entitled to demand the pharmaceutical company which requested clinical trials the institution to supply the investigational new drug, after the contract for clinical trials had terminated or cancelled. This study take into account the liability of the pharmaceutical company to trial subject. Secondly, it is researched the roles and authority of Institutional Review Board(IRB). IRB is Research Ethics Committee of the institution, in which clinical trials for new drug are conducted. According to the rule of Korea good clinical practice(KGCP), IRB is the mandatory organization which is authorized to approve, secure approval or disapprove the clinical trials for investigational new drug in the institution. The important roles are the review of ethical perspective of trial research and the protection of trial subject. Thirdly, this paper focuses if the participants are to be paid for the participation for clinical research. This is ethical aspect of clinical trials. It is resonable that the participant is reimbursed for expenditure such as travels, and other expenses incurred in participation in trials. It is not allowed that the benefit of clinical trials is paid to trial subject. The payment should not function as financial inducements for participations of trials. Finally, the voluntary consent of the trial subject is required. The institution ought to inform the subject, who would like to participate in trials, and it ought to received informed consent in writing for subject. In this regard, it is matter that trial subject has ability of consent. It is principle that the subject as severely psychogeriatric patient has not ability of consent. However, it is required that not only healthy people but also patients are allowed to take part in clinical trials of new drug, in order to confirm which the investigation new drug is secure. Therefore there are cases, in which the legal representative of subject consent the participation of the trials. In addition, it is very important that the regulations concerning clinical trials of new drug is to be systematically well-modified. The approach of legal and political approach is needed to achieve this purpose.

• 보건의료산업학회지
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• 제6권1호
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• pp.195-203
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• 2012

The purpose of this study was to identify clinical practice (clinical training education) and satisfaction depend on university hospital availability according to a survey with 850 healthcare-affiliated students. The collected data were analyzed with the SPSS17.0 program. The result was shown statistically significant difference depends on gender, major departments and satisfaction of college life. In addition, there were significant differences in satisfaction of clinical training education in the environmental aspects of practice depending on whether affiliated hospital or not. There were no significant correlation found between degree of satisfaction of clinical training education and the need for affiliated hospital (r = .204, p <.01). As a result, Attached to the university hospital can be helpful to healthcare-affiliated students on environmental and educational aspects of clinical training education. Therefore, the effective and practical training programs using university-affiliated hospitals are surely needed to develop and to apply the active support.

• 한국임상약학회지
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• 제28권4호
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• pp.347-354
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• 2018

Objective: This study was to investigate and develop a training program that integrated and strengthened clinical competence and capacity of hospital pharmacists which would be implemented at the pharmacy department of Ewha Womans University Mokdong Hospital. Methods: We assessed the training programs of hospital pharmacists in the United Kingdom, the United States and Japan and compared those of major hospitals in Seoul and Gyeonggi provinces in Korea. The survey assessed the satisfaction on the current educational programs for pharmacists at Ewha Womans University Mokdong Hospital and a newly designed education program was suggested. Results: The major differences of the programs among the Korean hospitals and Mokdong Hospital were the training period and contents of the entry-level pharmacist education program. The overall satisfaction of the training program was >3 points on 5-Likert scale in the survey. There was no significant difference of the satisfaction level based on the employment period of pharmacists. The pharmacists were in more than 7 training programs of clinical support work. We proposed the clinical support training for the new pharmacists to be separated from orientation and concentrated on actual work duty. In order to improve the competency, it was encouraged to participate the in-house seminar or certify the related fields provided by Korean Society of Health-system Pharmacists. Conclusion: The education program was assessed among different countries and hospitals of Korea. We suggested to update education program in the hospital to enhance pharmacists' competency.

• Journal of Periodontal and Implant Science
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• 제49권1호
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• pp.39-46
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• 2019

Purpose: This study aimed to evaluate the effects of i) the extent of peri-implant bone defects and ii) the application of bone cement on implant stability with respect to the measurement direction. Methods: In 10 bovine rib bones, 4 implant osteotomies with peri-implant bone defects of various widths were prepared: i) no defect (D0), ii) a 2-mm-wide defect (D2), iii) a 4-mm-wide defect (D4), and iv) a 8-mm-wide defect (D8). The height of all defects was 10 mm. Implant stability quotient (ISQ) values and Periotest values (PTVs) were measured after implant placement and bone cement application. Results: With increasing defect width, decreased ISQs and increased PTVs were observed. Statistically significant differences were found between groups D0 and D8, D0 and D4, and D2 and D8. Prior to bone cement application, inconsistent PTVs were found in group D8 depending on the measurement direction. Bone cement increased the implant stability. Conclusion: Peri-implant bone deficits measuring around 50% of the implant surface compromised implant stability. Clinically, PTVs should be cautiously interpreted in implants with large peri-implant defects due to inconsistent recordings with respect to the measurement direction.

• 응용통계연구
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• 제15권2호
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• pp.323-336
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• 2002

최근에 1상 임상실험 에서 사용되는 continual reassessment method (CRM)에 대한 연구가 활발히 이루어지고 있다. 본 논문에서는 세 명의 환자를 하나의 환자 군으로 삼아 동일한 용량을 투여하는 수정된 CRM에 대한 연구를 실행하였다. 지금까지 CRM에 대한연구는 대부분 시뮬레이션에 의존하여 왔지만, 본 논문에서는 모든 가능한 경우를 고려하는 방법(complete enumeration)을 사용하였다. 이 새로운 방법은 시뮬레이션을 대체할 유용한 방법이라 사료된다. 이 새로운 방법을 이용하여, 용량독성곡선이 logistic함수, hyperbolic tangent 함수, power 함수일 때, 수정된 CRM에서 결정한 최대허용용량에서의 독성 확률이 목표 독성 확률로 잘 수렴함을 보였다. 하지만, 실험 전에 용량들을 적절히 선택하지 못하면, 최대허용용량에서의 독성 확률이 목표 독성 확률과 상당한 차이를 낼 수도 있음을 발견하였다.

• Advances in Traditional Medicine
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• 제7권4호
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• pp.331-335
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• 2007

The utility of Lepidium sativum Linn (Garden cress) as a medicinal plant has increased many fold over a period of time. A survey of literature relating to the medicinal uses of L.sativum reveals it to be one of the widely used medicinal plants. It finds place in folklore medicine, Ayurveda, Unani and other indigenous systems of medicine. Following a large number of claims on the wide range of traditional medicinal properties of the plant, considerable efforts have been made to verify its efficacy as a curative agent through pharmacological investigations and clinical trials. In this article, a comprehensive account of the traditional uses, phytochemical investigation and therapeutic potential of Lepidium sativum is presented.

• Clinical and Experimental Pediatrics
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• 제53권9호
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• pp.824-829
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• 2010

The safety and effectiveness of colonoscopy in the investigation of lower gastrointestinal tract pathology in children has been established for more than 2 decades in Korea. The skill and experience have since advanced to the point that both diagnostic and therapeutic colonoscopy are now routinely performed by most pediatric gastroenterologists. Pediatric colonoscopy differs significantly from its adult parallels in nearly every aspect including patient and parent management and preparation, selection criteria for sedation and general anesthetic, bowel preparation, expected diagnoses, instrument selection, imperative for terminal ileal intubation, and requirement for biopsies from macroscopically normal mucosa. Investigation of inflammatory bowel disease, whether for diagnosis or follow-up evaluation, and suspected colonic polyps are the most common indication for pediatric colonoscopy. The child who presents with signs and symptoms of lower gastrointestinal disorder should undergo colonoscopy with biopsy to make the diagnosis, as well as to help determine the appropriate therapy. This review introduces practical information on pediatric colonoscopy, the author's experiences, and the role of colonoscopic examination in the diagnosis and treatment of pediatric lower gastrointestinal disorders.

• 대한치과기공학회지
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• 제29권1호
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• pp.59-72
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• 2007

This study executed to offer the basis for dental technology student who chanced better clinical training. This investigation conducted on 267 of seniors who have been taken clinical training to self written a questionnaire. We used and dealt a spss 12.0 program. Study results below 1. In a question about relationship, one answered "Harmonious" took largest proportion by 40.9% during training, and about the degree of satisfaction of campus life who answered :normal: were the most with 50.0% 2. In a question about clinical training place, most(50.0%) choose place less than 10 for clinical training, and more than 10 for clinical training with 29.7%. Residue statues was most of them resided own home with 78.6%. About their commuting time from home to training place, 50.0% was under 30min, 34.1% took time 30$\sim$60min. 3. In a question about clinical trainer, most (34.4%) choose as dental lab president, as each part manager with 34.1%, a senior with 7.6% and not exist to clinical trainer with 7.6%. 4. A perfect score about teaching efficiency and satisfaction of clinical practice of dental technology students was 5. The average of score about satisfaction of clinical practice was 3.25 and circumstance of clinical training got 3.50 as a highest score. the lowest score was 2.87 that is about satisfaction of clinical training period. The average of score of teaching efficiency was 3.25. 'a Role model' got 3.55 as the highest score and 'utility for student' got 3.12 as the lowest 3.12. 5. The result of T-test to see of the satisfaction according to the general character and clinic training condition between teaching efficiency is that the degree of satisfaction of clinical training showed statistical significance only in the degree of satisfaction of college life(p<0.05), teaching efficiency has a statistical significance with age and satisfaction of college life(p<0.05). 6. The relation between of teaching efficiency of clinical training and satisfaction of clinical training of dental technologic student has a statistical relation r=0.551 and a statistical meaning in significance leveler 0.01.

• 한국임상약학회지
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• 제23권2호
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• pp.129-136
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• 2013

Objectives: Among many new drugs that are under investigation with intent to treat cancer, oral kinase inhibitors are proven to be effective in numerous clinical trials and easy to administer. Due to these advantages the use of oral kinase inhibitors is increasing. Oral kinase inhibitors are metabolized by CYP450 which can result either increase of adverse effect or decrease of drug effect by drug interaction when used concurrently with other agents. In this research, the medication records of patients on oral kinase inhibitors from Oct. 2010 to Nov. 2011 were reviewed to investigate potential drug interactions. Methods: From Oct. 2010 to Nov. 2011, cancer patients in Inha University Hospital who took oral kinase inhibitors more than once were included. The patients' medication records were reviewed to list out concurrent medications that have interaction potential with oral kinase inhibitors, the frequency of concurrent use, and the severity of interaction result using Micromedex$^{(R)}$ and Lexicomp-online$^{(R)}$ as references. Results: As a result, 90 cases of drug with interaction potential were prescribed by Micromedex$^{(R)}$ and 179 cases by Lexicomp-online$^{(R)}$ data. In case of severity, 33.3% by Micromedex$^{(R)}$ and 26.3% by Lexicomp-online$^{(R)}$ were categorized as Major and 65.6% by Micromedex$^{(R)}$ and 72.6% by Lexicomp-online$^{(R)}$ as Moderate. The number of adverse events was 92 cases which 58.7% were on skin and 19.6% on Gastro-intestinal tract. Conclusions: Considerable number of drug with interaction potential was used though each oral kinase inhibitors showed differences in extent. Hence there exists the risk of drug interaction in patients taking oral kinase inhibitors with other drugs.

• Journal of Periodontal and Implant Science
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• 제48권1호
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• pp.47-59
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• 2018

Purpose: To evaluate the clinical and microbiological effects of the local use of egg yolk immunoglobulin against Porphyromonas gingivalis (anti-P.g. IgY) as an adjunct to scaling and root planing (SRP) in the treatment of moderate to severe chronic periodontitis. Methods: This was a randomized, placebo-controlled, double-blind trial involving 60 systematically healthy patients with moderate to severe chronic periodontitis. Subjects (n=20/group) were randomly assigned to receive SRP combined with subgingival irrigation of anti-P.g. IgY and anti-P.g. IgY mouthwash, subgingival irrigation of 0.2% chlorhexidine and 0.2% chlorhexidine mouthwash, or subgingival irrigation of placebo and placebo mouthwash for 4 weeks. Probing pocket depth, clinical attachment level, bleeding on probing, and the plaque index were evaluated at baseline and at 4 weeks. Subgingival plaque, gingival crevicular fluid, and saliva were simultaneously collected for microbiological analysis. Results: Our results showed that anti-P.g. IgY mouthwash was as effective as chlorhexidine at improving clinical parameters over a 4-week period. All the groups showed a significant reduction in levels of P.g. at 4 weeks. No significant difference was observed in the test group when compared to placebo regarding the reduction in the levels of P.g. Anti-P.g. IgY significantly suppressed the numbers of red complex bacteria (RCB) in subgingival plaque and saliva in comparison with placebo. No adverse effects were reported in any of the subjects. Conclusions: Within the limitations of the study, the present investigation showed that passive immunization with anti-P.g. IgY may prove to be effective in the treatment of chronic periodontitis due to its ability to improve clinical parameters and to reduce RCB. No significant differences were found between the anti-P.g. IgY and placebo groups in the reduction of P.g.