• 대한약학회:학술대회논문집
• /
• 대한약학회 2003년도 Proceedings of the Convention of the Pharmaceutical Society of Korea Vol.2-1
• /
• pp.22-24
• /
• 2003

This presentation briefly will be introduced on new drug approval process and the review of safety and efficacy of drugs in Korea. First, we will present the regulation related to new drug registration [Regulation of the Efficacy and Safety Evaluation of Drugs, etc (Notification No. 2003-17), Standards for Toxicity Test of Drugs, etc(Notification 1999-61) and GLP Regulation for Nonclinical Laboratory Studies (Notification No. 2000-63)] and the regulation related to clinical trial [Guidelines to Clinical Study Authorization for Drugs (Notification No. 2002-65)] and [Korean Good Clinical Practice(KGCP, Notification No. 1999-67) Regulation]. (omitted)

• Translational and Clinical Pharmacology
• /
• 제26권4호
• /
• pp.172-176
• /
• 2018

Mandatory registration of clinical trials in public registry can ensure the transparency of clinical trials. Public clinical trial registry of can provide current chronological and geographical distribution of clinical trial throughout the country. We used public clinical trial registry provided by Ministry of Food and Drug Safety to analyze current status of clinical trial from 2014 to 2016 in South Korea. The number of clinical trials in antineoplastic and immunomodulating agents area was the greatest, followed by cardiovascular system and antiinfectives for systemic use as a whole. From 2014 to 2016, overall number of clinical trials decreased while the number of phase I clinical trials increased. Seoul accounted for more than half number of clinical trials in Korea. Supports for clinical trials in non-metropolitan area needs to be considered.

• Communications for Statistical Applications and Methods
• /
• 제27권6호
• /
• pp.641-647
• /
• 2020

The 2 × 3 crossover design, a modified version of the 3 × 3 crossover design, is considered to compare the bioavailability of two generic candidates with a reference drug. The 2 × 3 crossover design is more economically favorable due to decrease in the number of sequences, rather than conducting a 3×3 crossover trial or two separate 2 × 2 crossover trials. However, when using a higher-order crossover trial, the risk of drop-outs and withdrawals of subjects increases, so the suitable statistical inferences for missing data is needed. The bioequivalence model of a of 2×3 crossover trial with missing data is defined and the statistical procedures of assessing bioequivalence is proposed. An illustrated example of the 2 × 3 trial with missing data is also presented with discussion.

• 한국콘텐츠학회논문지
• /
• 제13권12호
• /
• pp.1036-1047
• /
• 2013

본 연구는 불면과 관련된 무작위임상시험의 해외 연구 동향을 살펴보기 위하여 시계열적 키워드 비교 분석 및 네트워크 분석을 실시하였다. 분석에 사용된 자료는 'Insomnia'와 'Randomized Clinical Trial'의 연관 키워드를 사용하여 ClinicalTrials의 379건, Web of Science의 132건을 선정하였다. 분석 결과, ClinicalTrials에서는 불면과 약물요법을 중심으로 인지행동요법, 우울 등의 키워드가 네트워크를 이루고 있었다. WOS에서는 ClinicalTrials의 결과에 멜라토닌 키워드가 추가적으로 나타났다. 또한, 연구 대상자 중 특징적으로 노인과 여성에 대한 연구가 꾸준히 진행되는 것으로 파악되었다.

• Korean Journal of Acupuncture
• /
• 제28권3호
• /
• pp.177-186
• /
• 2011

Objectives : The aim of this study is to review clinical trials using Qigong exercise on patients with hypertension and to assess their methodology and results. Methods : Electronic literature searches for clinical trials (randomized trial, non-randomized trial, before-after study) of Qigong exercise were performed in 21 electronic databases (5 international databases and 16 Korean databases). English, Korean or Chinese articles were included. Laboratory or animal studies were excluded. Results : A total of 11 studies met the inclusion criteria. Five randomized controlled trials, Four non-randomized trials and two before-after studies were included. Seven studies used self-developed Qigong exercise. Two studies used Guolin Qigong exercise and two studies used Qigong exercise with an anti-hypertension drug. Of the nine randomized trials or non-randomized trials, four studies used an anti-hypertension drug control and three studies used waiting list controls. Compared to baseline, a change in blood pressure after the Qigong exercise treatment was significant in all studies. However, the results effect of blood pressure between Qigong exercise and controlled trials were not consistent. Conclusions : There are low-quality clinical trials of Qigong exercise for hypertension. To evaluate the effects of Qigong exercise, more rigorous trials are warranted.

• 고려인삼학회:학술대회논문집
• /
• 고려인삼학회 1998년도 Advances in Ginseng Research - Proceedings of the 7th International Symposium on Ginseng -
• /
• pp.289-299
• /
• 1998

In this present study, we investigated the effects of red ginseng extract and its active constituents - Rbl , Re, Rgl on cycloheximide (CXM)-induced amnesia in the passive avoidance task in rats. Red ginseng water extract at 0.05-0.5 g/kg could improve CXM-induced amnesia in rats, Furthermore, the recovery effect of Rbl at 10 mghg administered 30 min before training trial from CXM-induced amnesia was better than those of Rbl administered other time before or after training trial. Rbl at 0.001-0.1 mghg could significantly improve CXM-induced amnesia and at 1 mghg completely augmented, but at 10 mghg its improving effect slightly weakened. Rgl and Re at 0.3-10 mghg could significantly improve CXM-induced amnesia and Rgl at 10 mg/kg completely avgmented. On the other hand, Rbl at 10 mghg could prolong the step through latencies in the training trial. These results suggest the beneficial effect of red ginseng extract on CXM-induced amnesia in rats could mainly due to the contribution of its active constituents - Rbl, Re, Rgl. The improving effect of Rbl on CXM-induced amnesia was best among the three active constituents. But the reduction in the improving effect of Rbl at 10 mg/kg might be due to the decrease in motor activity and attention to the passive avoidance task.

• 대한기관윤리심의기구협의회지
• /
• 제5권1호
• /
• pp.14-20
• /
• 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.

• 대한한방내과학회지
• /
• 제38권2호
• /
• pp.201-216
• /
• 2017

Objective: This research aimed to understand patients' perceptions of Korean medicine treatment for osteoporosis in a clinical trial setting. Methods: Ten patients participating in a clinical trial of a herbal medicine drug for osteoporosis were invited to an interview. Data were collected by in-depth interviews and patient observations. This qualitative study adopted the case study research method, and within-case and cross-case analyses were conducted. Results: A model of the patients' osteoporosis management planning was derived from the study. The results showed that the patients' perceptions of osteoporosis were derived from their knowledge and experience during diagnosis and treatment of the condition. Two groups of patients were recognized: those who overlooked the importance of osteoporosis and those who recognized the importance of osteoporosis. Before making treatment decisions about osteoporosis, the patients evaluated the treatment options and weighed the advantages and disadvantages of each option. When evaluating their treatment, the patients combined their knowledge and experience of Korean and western medicine treatments. Their experience of participating in the clinical trial influenced the management planning of osteoporosis. Two major reasons for low compliance with osteoporosis treatment were ignorance of the disease and insufficient information provided by doctors. Conclusion: The results of this qualitative study pointed to four strategies that could be employed to improve accessibility to Korean medicine treatment for osteoporosis: the dissemination of comprehensive information on osteoporosis in the clinic and mass media, promotion of Korean medicine therapies for osteoporosis, management of clinical trial participants, and insurance coverage for Korean medicine.

• Journal of Pharmaceutical Investigation
• /
• 제22권1호spc1호
• /
• pp.57-63
• /
• 1992

• 대한약학회:학술대회논문집
• /
• 대한약학회 2001년도 Proceedings of International Convention of the Pharmaceutical Society of Korea
• /
• pp.317.2-318
• /
• 2001