• 한국임상약학회지
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• 제28권2호
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• pp.146-153
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• 2018

Objective: Multi-regional clinical trials have been widely used for accelerating global drug development by multinational pharmaceutical companies. In this study, we aimed to review and analyze the international trends in regulations and guidelines on multi-regional clinical trials by regulatory authorities and international organizations, such as International Conference on Harmonisation, for referring to policies, including development of domestic guidelines for multi-regional clinical trials. Methods: The policies, regulations, and guidelines published by the US Food and Drug Administration, European Medicines Agency, Pharmaceuticals and Medical Devices Agency (Japan), and China Food and Drug Administration were searched, and the International Conference on Harmonisation E17 draft guideline was reviewed. Results: The regulatory authorities in developed countries have developed and implemented regulations and guidelines on multi-regional clinical trials to promote simultaneous global drug development and evaluate the regional differences in drug safety and efficacy. International Conference on Harmonisation developed the draft guideline for planning/designing of multi-regional clinical trials in 2016, which recommends the general principles for strategy-related issues and design of multi-regional clinical trials, and for protocol-related issues, such as consideration of regional variability, subject selection, dose selection, endpoints, comparators, overall sample size, allocation to regions, collecting information on efficacy and safety, and statistical analysis. Conclusion: It is important to understand the international regulatory requirements for designing and planning of multi-regional clinical trials for global drug development. Moreover, it is necessary to prepare multi-regional clinical trial guidelines in accordance with the Korean regulation for clinical trials and drug administration.

• 한국임상약학회지
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• 제24권1호
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• pp.45-52
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• 2014

Objective: To evaluate the clinical manifestations and causative drugs of the outpatient adverse drug reactions (ADRs) reported by community pharmacy. Methods: From April 2013 to September 2013, all outpatient ADRs reported by community pharmacy to Regional Pharmacovigilance Center of Korean Pharmaceutical Association were included. The causality of ADRs was assessed by the criteria of WHO-Uppsala Monitoring Centre. The clinical features and the offending drugs were analyzed using the WHO-Adverse Reaction Terminology and the classification of American Hospital Formulary Service Drug Information, respectively. Results: 2,826 (97.0%) of the total 2,912 ADRs had causal relationship. The 1,923 patients with mean age of 55.1 years and female fraction of 66.5% were included in the ADRs. Gastrointestinal (33.6%), nervous system (14.9%), and skin (13.5%) symptoms were common in ADRs. Analgesic drugs (19.7%), gastrointestinal drugs (17.7%), and central nervous system drugs (11.0%) were prevalent offending drugs. The leading causative generic drug was the complex of acetaminophen and tramadol. Among 203 ADRs by the nonprescription drugs, the most common clinical features were skin (37.4%) and gastrointestinal (23.6%) symptoms and the most prevalent offending drugs were analgesic drugs (40.0%) and mucocutaneous system drugs (16.3%). The combination of acetaminophen and chlorzoxazone was the leading causative generic in nonprescription drugs. Conclusion: In this study, gastrointestinal symptom was the most common manifestation and analgesic drug was the most common causative drug in outpatient ADRs reported by community pharmacy.

• 한국임상약학회지
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• 제29권2호
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• pp.133-137
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• 2019

Atorvastatin is one of the most widely prescribed medications for dyslipidemia treatment. In Korea, post combined therapy with ezetimibe, a 73-year-old woman was reported by a community pharmacy to have experienced visual field defect, which recovered after drug discontinuation. She had never experienced this symptom before, and several studies have reported an association between use of statins and visual disorders such as blurred vision, diplopia, and cataract. Blockage of cholesterol accumulation, oxidative stress, or myopathy is expected to be a cause of this symptom. Naranjo scale, Korean causality assessment algorithm (Ver.2), and World Health Organization-Uppsala Monitoring Center (WHO-UMC) criteria were the three tools used to determine causality between the visual disorder and atorvastatin. The results represent 'probable', 'certain', and 'probable/likely' causality, respectively. Our results, in combination with a review of literature, indicate that ocular adverse effects are highly likely related to atorvastatin.

• 대한약학회:학술대회논문집
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• 대한약학회 2001년도 Proceedings of International Convention of the Pharmaceutical Society of Korea
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• pp.282.3-283
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• 2001

• 대한약학회:학술대회논문집
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• 대한약학회 2001년도 Proceedings of the Pharmaceutical Society of Korea
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• pp.218.1-218.1
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• 2001

• 대한약학회:학술대회논문집
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• 대한약학회 2000년도 NEW STRATEGY FOR DRUG DEVELOPMENT IN POST-GENOMIC ERA(대한약학회)
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• pp.233.1-233.1
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• 2000

• Natural Product Sciences
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• 제13권2호
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• pp.144-147
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• 2007

Using antifungal activity-guided fractionation, an actinomycete, Streptomyces padanus strain TH-04, which was isolated from mummified peaches infected with Monilinia fructicola, was found to produce the valinomycin (1). The structure of 1 was established using spectroscopic data, which including one- and two-dimensional NMR experimental and mass spectroscopy. Valinomycin (1) showed antifungal activity against Phytophthora capsici, with an IC$_{50}$ value of 15.9 ${\mu}$g/mL.

• 한국임상약학회지
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• 제28권4호
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• pp.308-319
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• 2018

Background: Some mental illnesses such as depression are known to be one of the risk factors of suicide and proper antidepressant therapy can reduce suicidal behavior. Objectives: This study aimed to analyze regional variations in antidepressant consumption and adherence, suicide rate, prevalence of suicide related mental disorders, and access to relevant healthcare services. Methods: Cross-sectional analyses were conducted using National Patients Sample data compiled by the Health Insurance Review and Assessment Service between 2014 and 2016. We included patients who had a diagnosis record of suicide related mental disorders during the study period. Cause of death statistics and National health and medical statistics were used to identify suicide rate and distribution of healthcare service. We conducted visual analyses, chi-squared tests, independent t-tests and correlation analyses to demonstrate regional variations. Results: Between 2014 and 2016, the average prevalence of suicide related mental disorders was 5.4 per cent. Suicide rate and prevalence of suicide related mental disorders were higher in Gangwon, Chungcheong, and Jeolla (p < 0.001), and lower in Seoul (p < 0.001) than the national average. Unexpectedly, regional variations in antidepressant consumption were seen in the limited area including Daejeon, Chungnam and Gyeongnam (p < 0.05). The number of mild patient-centered clinics was associated positively with antidepressant consumption (p < 0.01) and associated negatively with suicide rate (p < 0.01). Conclusion: There were some regional variations in prevalence of suicide related mental disorders, antidepressant adherence and suicide rate. The higher level of antidepressant therapy and the lower level of suicide rates were seen in regions with easy access to mild patient-centered clinics.

• 한국임상약학회지
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• 제29권4호
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• pp.267-277
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• 2019

Backgrounds: With the globalization of drug development, multi-regional clinical trials (MRCTs) have emerged to facilitate rapid availability of medicines to patients worldwide. The present study aimed to has explored attitudes and perceptions towards adopting the Korean MRCT guideline. Methods: An online survey, consisting of 16 questions, classified into two subjects, was administered to stakeholders in Korea. Most quantitative components were measured using the Likert scales. A content analysis of the qualitative components was carried out to identify the keywords in open-ended responses. Results: A total of 94 survey responses were analyzed: 51 participants from pharmaceutical companies, 11 from clinical research organizations, and 21 from clinical trial centers. The content of the guideline was rated as appropriate for clarity, acceptability, and applicability (96.8, 96.8, and 93.6%, respectively). The local environmental impact of the systemic/political, academic/technical, and industrial/economical aspects of the guideline was rated as appropriate at 95.7, 97.9, and 91.5%, respectively. The suggested adoption period was 1~2 years (40, 42.6%). The concept and individuals' domestic circumstances were the key problems affecting the clarity, applicability, and local environmental impact of the guideline. Conclusion: The Korean MRCT guideline was well-developed. Their overall impact on the local environmental impact of MRCTs in Korea was expected to be beneficial, but methods are needed to minimize the negative impacts. The findings of this study can inform the priorities for the future adoption of the guideline in Korea.

• Archives of Pharmacal Research
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• 제26권7호
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• pp.516-520
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• 2003

A reversed-phase high performance liquid chromatographic method was developed to determine the contents of psoralen and angelicin from some medicinal herbs. The optimum eluent for chromatography was 20 v/v% acetonitrile in water on a Zorbax 300SB $C_{18}$ column. The identification was carried out by comparing the retention time and mass spectra of the relevant peaks with their standards. The variation of the concentration of psoralen and angelicin was wide between different species. The seeds of Psoralea corylifolia showed the highest contents of psoralen (7.8 mg/g) and angelicin (2.3 mg/g) among the tested herbs.