• 약학회지
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• 제58권2호
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• pp.112-124
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• 2014

This study aimed to develop a regulation system for off-label drug use to secure the safe use of marketed drugs. We searched governmental documents for national and global regulating systems of off-label drug uses and a body of academic literature to explore current regulating trends. We included European Union, United Kingdom, United States of America, Australia and Japan, and critically reviewed the regulation of off-label drug use in four issues, which were a regulatory structure, safety control before and after off-label use, and information management. The findings of the present investigation called for several measures in off-label drug uses: enhancing prescribers' self-regulation, providing up-to-date information to prescribers for evidence-based practice and to patients for their informed consent, making evidence with scientific rigor, building an official registering process for off-label use in good quality and extending the role of pharmaceutical industry in pharmacovigilance. At last, we proposed a new system so as to regulate and evaluate off-label drug uses both at national and institutional level. In the new system, we suggested a clear-cut definition for clinical evidence that applicants would submit. We newly introduced an official 'Off-Label Drug Use Report' to evaluate the safety and clinical efficacy of a given off-label drug use. In addition, we developed an algorism of the regulation of off-label drug use within an institution to help set up the culture of evidence-based practices in off-label drug uses.

• 한국응용약물학회:학술대회논문집
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• 한국응용약물학회 2006년도 Proceedings of The Convention
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• pp.23-39
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• 2006

The application of the knowledge from the Human Genome Project to clinical medicine will be through both industrial drug development and the application of pharmacogenomics (PG) to patient care. The slow uptake of clinical innovations into clinical practice can be frustrating, but understanding the history of acceptance and sustaining medical innovation is critically important to position PG to succeed. This primarily means that PG tests must have legitimacy; they must be thoroughly validated, must be cost-effective, must be widely accepted by medical practitioners, must be supported by public policy, and must have a way of being easily incorporated into current medical practice. They must also lead to actionalble decisions by health care providers for their patients. Innovative PG assays should be tested in the best US laboratories, and reimbursement for testing must be accepted at the federal and state level. The companies providing these PG tests should be capable of supporting the interpretation and use of the test throughout medical practice. Advances such as the addition of PG information to drug labeling and the routine use of validated biomarkers to determine choice of cancer chemotherapy have been made. The PG research community must pay attention to the principles that have been previously described for acceptance and sustaining medical innovations in order for PG to be widely accepted in clinical medical practice.

• Bulletin of the Korean Chemical Society
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• 제35권5호
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• pp.1333-1336
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• 2014

Expanded polytetrafluoroethylene (ePTFE) grafts have been used as vascular access for many patients suffering from end stage renal disease. However, the vascular graft can cause significant clinical problems such as stenosis or thrombosis. For this reason, many studies have been performed to make drug eluting graft, but initial burst is major problem in almost drug eluting systems. Therefore we used biodegradable polymer to reduce initial burst and make sustained drug delivery. The ePTFE grafts were dipped into a paclitaxel-dissolved solution and then PLGA-dissolved solution was passed through the lumen of ePTFE. We analyzed whether the dose of paclitaxel is enough and the loading amount of PLGA on ePTFE graft increases according to the coating solution's concentration. Scanning electron microscope (SEM) images of various concentration of PLGA showed that the porous surface of graft was more packed with PLGA by tetrahydrofuran solution dissolved PLGA. In addition, in vitro release profiles of Ptx-PLGA graft demonstrated that early burst was gradually decreased as increasing the concentration of PLGA. These results suggest that PLGA coating of Ptx loaded graft can retard drug release, it is useful tool to control drug release of medical devices.

• Biomolecules & Therapeutics
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• 제15권1호
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• pp.1-6
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• 2007

The application of the knowledge from the Human Genome Project to clinical medicine will be through both industrial drug development and the application of pharmacogenomics (PG) to patient care. The slow uptake of clinical innovations into clinical practice can be frustrating, but understanding the history of acceptance and sustaining medical innovation is critically important to position PG to succeed. This primarily means that PG tests must have legitimacy; they must be thoroughly validated, must be cost-effective, must be widely accepted by medical practitioners, must be supported by public policy, and must have a way of being easily incorporated into current medical practice. They must also lead to actionalble decisions by health care providers for their patients. Innovative PG assays should be tested in the best US laboratories, and reimbursement for testing must be accepted at the federal and state level. The companies providing these PG tests should be capable of sup-porting the interpretation and use of the test throughout medical practice. Advances such as the addition of PG information to drug labeling and the routine use of validated biomarkers to determine choice of cancer chemotherapy have been made. The PG research community must pay attention to the principles that have been previously described for acceptance and sustaining medical innovations in order for PG to be widely accepted in clinical medical practice.

• Natural Product Sciences
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• 제24권2호
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• pp.119-124
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• 2018

Two triterpenoids, arjunolic acid (1), belleric acid (2), five phenylethanoids, martynoside (3), orobanchoside (4), 3,4-dihydroxyphenethylalcohol-6-O-caffeoyl-${\beta}$-$\text\tiny{D}$-glucoside (5), leucosceptoside B (6), lunariifolioside (7), four phenolic acids, ferulic acid (8), syringic acid (9), vanillic acid (10), 4-hydroxybenzoic acid (11), and one lignan, (+)-syringaresinol-${\beta}$-$\text\tiny{D}$-glucoside (12), were isolated from the roots of P. umbrosa. All isolated compounds were explored for their antioxidant potential in the DPPH and ABTS assays. In DPPH assay, compound 5 showed high antioxidant capacity. Compounds 3, 4, 6, and 7 displayed considerable antioxidant activities. In addition, compounds 5-7 exhibited potential antioxidant capacities in the ABTS assay.

• Natural Product Sciences
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• 제25권4호
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• pp.334-340
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• 2019

Cuscuta chinensis Lam. and Cuscuta japonica Choisy are parasitic plants. C. chinensis seeds were traditionally used for treatment of kidney and liver deficiencies. C. japonica seeds were used as tonic medicine to improve liver function and strengthen kidneys, treatment of high blood pressure, chronic diarrhea, and sore eyes. Cuscutae Semen are seeds of only C. chinensis in Korean Herbal Pharmacopoeia (K.H.P.). The developed HPLC-PDA method easily, accurately, and sensitively quantified using eight marker compounds [hyperoside (1), astragalin, (2), quercetin (3), kaempferol (4), chlorogenic acid (5), 3,4-di-O-caffeoylquinic acid (6), 1,5-di-O-caffeoylquinic acid (7), and 4,5-di-O-caffeoylquinic acid (8)]. In addition, the method may be used to distinguish seeds between C. chinensis Lam. and C. japonica Choisy. Furthermore, the result from the current study was applied to clarify samples between steam processed and unprocessed samples of C. chinensis by pattern analysis.

• Archives of Pharmacal Research
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• 제21권2호
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• pp.89-105
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• 1998

In the past decade, significant progress has been achieved in the battle against hepatitis B virus. In addition to the immunomodulating agents such as interferon-.alpha., and thymosin, many novel antiviral agents have been discovered, among which nucleoside analogues are the mainstay. New-generation compounds such as 3TC and famciclovir have shown promise in the treatment of patients chronically infected by this virus, and are on the line for approval. However, viral rebound after cessation of therapy still remains a major problem. Additionally, the reports on the drug resistance to these antiviral agents suggest that combination therapy will be the eventual strategy (Bartholomew et al., 1997; Tipples et al., 1996). Therefore, developments of safe and effective antiviral agents which do not cross-resist with currently available antiviral drugs are still much needed.

• Advances in Traditional Medicine
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• 제10권2호
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• pp.66-78
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• 2010

Acute (24 h) and chronic (90 days) oral toxicity studies on the ethanol extract of Trigonella foenumgraecum Leguminosae (L.) seeds were carried out. Acute dosages were 0.5, 1.0 and 3 g/kg while chronic dosage was 100 mg/kg per day of the extract. All morphological, biochemical, haematological and spermatogenic changes, in addition to mortality, body weight changes and any change in vital organs were recorded. Histopathological investigations were done on vital organs. Growth arrest in the treated animals was observed. The treated mice gained no significant weight during chronic treatment while there was a significant gain in body weight of the control group mice. Biochemical studies revealed a significant decrease in blood sugar levels of fenugreek treatment groups while haematological parameters remained comparable to the control. In the treatment, male group there was a significant decrease in weight of testes as compared to the control. There was a marginal weight gain in kidney weight of mice after chronic treatment as compared to the control. Fenugreek chronic treatment caused a highly significant spermatotoxic effects in male mice.

• Journal of Pharmaceutical Investigation
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• 제30권1호
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• pp.33-37
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• 2000

One of the methods to increase the solubility of a drug is to use complexation with a cyclodextrin. Due to the hydrophobic nature of the interior cavity of the cyclodextrin, it has been known that undissociated lipophilic drugs can be included within the cyclodextrin by hydrophobic interaction. Recently, inclusion of hydrophilic or dissociated form of a drug has been investigated. In this study, the synergism of pH and complexation with $hydroxypropy-{\beta}-cyclodextrin\;(HP\;{\beta}\;CD)$ to increase the solubility of two oxicam derivatives was investigated. In addition, the effect of partition coefficient of dissociated and undissociated form of the drug on the extent of complexation with HP ${\beta}$ CD was studied. The solubility was measured by equilibrium solubility method. The solubility of tenoxicam and piroxicam increased exponentially with an increase in solution pH above the pKa of the drug in the presence and absence of HP ${\beta}$ CD. The solubility of the drugs increased linearly as a function of HP ${\beta}CD$ concentration at fixed pH. Although the stability constant of ionized species is less than that of the unionized species, the concentration of the ionized drug complex is greater than that of the unionized drug complex due to higher concentration of ionized species at pH 7.3.

• 보건행정학회지
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• 제16권4호
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• pp.147-168
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• 2006

Technological innovation has been regarded as the core competence for the economic growth of individual, as well as organization and country. Pharmaceutical innovation, what we call new medicines, influence people's longevity and productivity by increasing output per hour worked. Therefore, using claims data on virtually all the drugs and diseases of over 550,000 people enrolled in National Health Insurance Program in Korea, we examined the impact of the vintage (original FDA and KFDA approval year) of drugs used to treat a patients from July 1st to December 31st in 2002 on the patient's mortality at the end of 2004, controlling for demographic characteristics(age and sex), utilization of medical services, and the nature and complexity of illness. We found that people using newer drugs are less likely to die at the end of 2004, conditional on covariates. The estimated mortality rates were declining with respect to drug vintage for 1970s, 1980s and 1990s and highly significant. In addition to estimating the model for the entire sample, we estimated the model separately for several disease categories classified by Korean Classification of Disease. Estimates of three drug vintage variables for subgroups of people with (1)neoplasms, (2)endocrine, nutritional and metabolic diseases, and (3)the diseases of circulatory system displayed similar patterns.