• Journal of Society of Preventive Korean Medicine
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• v.18 no.1
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• pp.23-41
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• 2014

Objective : The purpose of this study was to lay the groundwork for understanding the details and scope of the legal definition of medicinal products, following the changes in the relevant laws and regulations. This will let readers properly understand the origins of the ongoing conflicts on herbal drugs and new drugs from natural products that are present in the medical field and the medical industry. Possible solutions are proposed in the end. Method : I analyzed the changes in definition of medicinal products since 1945 that have been used in relevant laws and regulations(i.e. Pharmaceutical Affairs Act) and drug approval process(i.e. New Drug Application and Investigational New Drug Application). Results : Legal definition of medicinal products has changed in accordance with the changes in the pharmaceutical industry, such as the establishment of dualistic medical and pharmaceutical System and the introduction of the substance patent. Due to those changes, boundaries of Western medicinal products and health food expanded, while those of herbal medicine products relatively downscaled. Conclusion : Legal definition of medicinal products-i.e. Herbal Drugs, Crude Drugs, and New Drugs from Natural Products-should be reestablished according to academic legitimacy and dualistic medical and pharmaceutical System.

• The Journal of Korean Medical History
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• v.27 no.2
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• pp.11-37
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• 2014

Objectives : The purpose of this study was to analyze and identify the problems of the changes in regulations that are relevant to approval, notification, and review of herbal medicinal preparations and crude drug preparations. Methods : I collected the regulations of approval, notification, and review of medicinal products mostly from official gazettes, analyzed enactment and amendments regarding herbal medicinal preparations and crude drug preparations, and studied it from the view point of Korean medicine field. Results : Regulations in regards to approval, notification, and review of herbal medicinal preparations and crude drug preparations were first established in 1978. Herbal drugs started to be categorized as crude drug preparations in 1981 and the regulatory outlines were completed in 1999. From 2008 to 2012, the regulatory standards that let crude drug preparations be new drugs from natural products were established. Through those procedures, the followings became crude drug preparations: 1) wholly new prescriptions that are not recorded in Korean Medical Classics, 2) prescriptions that are recorded in Korean Medical classics but prepared with new standard, composition and efficacy, 3) prescriptions that are recorded in Korean Medical classics but prepared with new formulation, and 4) herbal drugs. In case of herbal medicinal preparations, however, only regulations that are related to 1) drugs prepared with new compositions that are not recorded in Korean Medical Classics, 2) drugs with same prescription and same formulation, and 3) drugs with new formulation were arranged. Conclusions : Actual circumstances on crude drug-oriented regulations regarding approval, notification and review and future forms of prescription and drug administration in Korean Medical Institutions can be expected due to expansion in range of herbal medicinal preparations and shrink in that of on-site preparations. Reasonable improvement in efficient usage of modernized herbal medicinal preparations in Korean medical institutions and prospective cooperation from related pharmaceutical industry are needed.

• Korean Journal of Clinical Pharmacy
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• v.33 no.4
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• pp.290-304
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• 2023

Background: Innovative Alzheimer's disease drugs received approval in the United States in 2021 and 2023. This study aims to assess the safety and efficacy of these novel treatments, elucidate their mechanisms of action, and compare their impact on cognitive function improvement with approved drugs. Methods: We conducted a comprehensive search of pivotal clinical studies related to Alzheimer's disease treatments in PubMed/Medline, Embase, and the Cochrane Library databases from January 1st, 2020 to December 31st, 2022. Meta-analysis was performed using RevMan 5.4 software. Results: A total of 14 studies were included in this systematic review. When compared to the placebo, the new drugs did not exhibit a statistically significant effect on MMSE (Mini-Mental State Examination) (mean difference= -0.04, 95% confidence intervals [CIs]: -0.31, 0.23, N=3662, I²=0%). However, they demonstrated a significant impact on ADAS-cog (Alzheimer's Disease Assessment Scale-Cognitive Subscale) (standardized mean difference= -0.15, 95% CIs: -0.2, -0.1, N=6710, I²=17%). When compared to the approved drugs, the new drugs showed a statistically significantly lower effect on MMSE (test for subgroup difference Chi²=23.13, N = 5870, p<0.00001) but showed only a trend of decreased efficacy on ADAS-cog (Chi²=1.16, N = 8670, p=0.28). Conclusion: New drugs yielded diverse clinical endpoint results compared to the placebo, and in comparison to existing approved drugs, they exhibited lower efficacy in improving cognitive function. The safety profile of these new drugs, as reported in clinical trials, was generally well-tolerated.

• Korean Journal of Pharmacognosy
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• v.45 no.1
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• pp.17-22
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• 2014

Grapes has long been used for food, and reported as containing polyphenol which has antioxidant and anti-cancer effects. Neuroinflammation is chronic inflammation at the brain, lead to neurodegenerative diseases. In this study, quercetin-3-O-glucuronide (QG) isolated from the leaf of Vitis labruscana has anti-neuroinflammatory effects. QG were investigated using MTT assay, western blot, nitric oxide (NO) assay, prostaglandin $E_2$ ($PGE_2$) assay, cytokine assay in lipopolysaccharide (LPS)-induced inflammation in BV2 cells. QG dose-dependently attenuated the expression of inducible nitric oxide synthase (iNOS) and cyclooxygenase-2 (COX-2), accordingly inhibited the production of NO and $PGE_2$. QG decreases the levels of proinflammatory cytokine such as tumor necrosis factor-${\alpha}$ (TNF-${\alpha}$), interlukin-$1{\beta}$ (IL-$1{\beta}$). Thereby, QG may offer therapeutic potential for treatment of neurodegenerative disease related to neuroinflammation.

• Korean Journal of Clinical Pharmacy
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• v.28 no.1
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• pp.40-50
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• 2018

Objective: This study presented the analysis period, the complexity of combined therapy and comparator choice as the key limitations in the economic evaluation of new drugs, and discussed programs for coping with these limitations. Methods: This study evaluated the post-evaluation, risk-sharing agreement, extra funding program, and flexible incremental cost-effectiveness ratio (ICER) threshold as actions or programs that would increase accessibility to costly new drugs. The study also presented the cases of other countries. The application of the post-evaluation was considered to deal with high uncertainty regarding new drugs. Results: The risk-sharing agreement was introduced in European countries as well as South Korea and has been responsible for the shift from using the financial schemes to outcome-based schemes. The drug funding program has had troubled in securing stable extra funds. The application of higher ICER in the economic evaluation of expensive and innovative oncology drugs was criticized because of the inequity between oncology patients and patients with other diseases. Conclusion: Therefore, introducing and applying actions that would increase the accessibility to costly new drugs in South Korea have been deemed necessary after careful reviews and discussions with various stakeholders (insurer, policy makers, pharmaceutical companies and patients).

• Korean Journal of Pharmacognosy
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• v.43 no.1
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• pp.39-45
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• 2012

Cirsium japonicum var. ussuriense has long been used in herbal medicine for the treatment of arthritis, dyspepsia, and bleeding in Korea. In the present study, we investigated anti-inflammatory effects of C. japonicum var. ussuriense against lipopolysaccharide(LPS)-induced activation in RAW264.7 cells by the expression of heme oxygenase (HO)-1. The 70% EtOH extract of the aerial parts of C. japonicum var. ussuriense (CJE), showed the potent anti-inflammatory effects on LPS-induced inflammation in RAW264.7 cells. The anti-inflammatory effect of CJE was demonstrated by the suppression of pro-inflammatory mediators, including pro-inflammatory enzymes (inducible nitric oxide synthase and cyclooxygenase-2). Furthermore CJE induced HO-1 expression through nuclear translocation of nuclear factor E2-related factor 2 (Nrf2) and increased HO activity in RAW264.7 macrophages. The effects of CJE on LPS-induced NO and $PGE_2$ productions were partially reversed by an HO-1 inhibitor, tin protoporphyrin (SnPP). Therefore, it is suggested that CJE-induced HO-1 expression plays a role of the resulting anti-inflammatory effects in macrophages. These results suggest that CJE may be a promising candidate for the treatment of inflammatory diseases.

• Korean Journal of Clinical Pharmacy
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• v.31 no.1
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• pp.1-11
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• 2021

Objective: This study aimed to overview and assess the effectiveness of the policies and regulations that have governed new drug access in Korea, and to propose policies to enhance patient access to drugs, particularly for new innovative medicines. Methods: We approached drug access issues in two perspectives: approval lag (or availability) and reimbursement lag (or affordability). The issues were identified and evaluated through the review of literature, public documents, reports published by the government agencies and private organizations, and news articles. Results: To shorten approval lag, it is recommended to hire and train more reviewers at the Ministry of Food and Drug Safety. Increasing user fees to a realistic level can facilitate this process. To reduce reimbursement lag, flexible incremental cost-effectiveness ratio threshold, alternative cost-effectiveness evaluation, and establishment of funding source other than the national health insurance are identified as the areas to be improved. Conclusion: The current policies and regulations had to be supplemented by new systems to drastically promote patient accessibility to new drugs, consequently in order to promote national public health.

• Herbal Formula Science
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• v.12 no.1
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• pp.93-104
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• 2004

Recently, more and more natural herbal products are investigated and used popularly. Pharmaceutical companies of Korea are very interested in developing herbal new drugs. And oriental doctors also need popular, modernized form of oriental drugs. The objective of this article is, first, to examine current situations of drug development in Korea, second, to know general concepts of patent and third, to think about new drug development and patent in oriental medicine's point of view. With consideration of oriental medicine's characteristics, concepts of new drug and patent should be improved. Therefore, the oriental pharmaceutical industry and developments of oriental new drugs could be inspired to further efforts.

• Archives of Pharmacal Research
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• v.29 no.7
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• pp.582-586
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• 2006

Due to consumer reluctance to take synthetic drugs for nematode infections and the appearance of resistance to anthelminthic drugs, new drugs from natural products must be developed. Caenorhabditis elegans is one of the freely living nematodes and serves as a good model system for screening anthelminthic drugs. In this study, thirteen flavonoid derivatives were tested for anthelminthic activity and the relationships between their activities and structures were investigated. The structural information combined with the data for the larval growth inhibition of C. elegans provided meaningful structural insights in the search for new anthelminthic drugs.

• Proceedings of the Korean Society of Applied Pharmacology
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• 1994.11a
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• pp.93-98
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• 1994

Most drug discovery has focused in recent years on the development of molecules that either interact with or block receptors, proteins that act as on-off switches for genetic activity, on the surfaces of human cells. Now, we have developed a technology that targets “receptors inside the cell” (intracellular receptors), opening a new and compelling avenue for drug discovery. Our receptor-based small molecule drugs can be catagorized in two ways: 1) receptor agonists, or molecules that activate a receptor; and 2) receptor antagonists, or drugs that inactivate a receptor.