• International Journal of Stem Cells
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• 제16권1호
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• pp.16-26
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• 2023

Despite long-term research achievements, the development of cell therapy (CT) products remains challenging. This is because the risks experienced by the subject and therapeutic effects in the clinical trial stage are unclear due to the various uncertainties of CT when administered to humans. Nevertheless, as autologous cell products for systemic administration have recently been approved for marketing, CT product development is accelerating, particularly in the field of unmet medical needs. The human experience of CT remains insufficient compared with other classes of pharmaceuticals, while there are countless products for clinical development. Therefore, for many sponsors, understanding the rationale of human application of an investigational product based on the consensus and improving the ability to apply it appropriately for CT are necessary. Thus, defining the level of evidence for safety and efficacy fundamentally required for initiating the clinical development and preparing it using a reliable method for CT. Furthermore, the expertise should be strengthened in the design of the first-in-human trial, such as the starting dose and dose-escalation plan, based on a sufficiently acceptable rationale. Cultivating development professionals with these skills will increase the opportunity for more candidates to enter the clinical development phase.

• 한국식품과학회지
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• 제52권1호
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• pp.89-93
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• 2020

본 연구에서는 패혈증비브리오균에 대한 PEM, RCM, RRM과 CTM 메탄올 추출물의 항균 활성을 평가하였다. 96-well microplates를 사용한 액체 배양법 실험 결과 4가지 천연물은 200 ㎍/mL 농도에서 80%이상의 항균 효과를 나타내었다. 또한 페이퍼디스크 확산법을 사용하여 항균 활성을 평가한 결과 4가지 천연물은 20, 40 mg/disc의 농도에서 농도 의존적으로 패혈증비브리오균의 성장을 억제하였다. 다음으로 4가지 천연물의 안전성을 평가하기 위해 MTS assay를 통해 HeLa 세포에 대한 독성을 확인한 결과 100, 200 ㎍/mL의 농도에서 세포 독성을 나타내지 않았다. 또한 LDH assay를 사용하여 패혈증비브리오균의 HeLa 세포에 대한 세포막 손상 억제 효과를 평가한 결과 PEM, RCM, RRM과 CTM 메탄올 추출물은 200 ㎍/mL 농도에서 세포막 손상억제 효과를 나타내었다. 다음으로 바닷물과 조개를 사용한 수족관 모델에서 4가지 천연물의 메탄올 추출물 혼합액 200 ㎍/mL 농도는 colony 생성을 현저하게 감소시켜 패혈증비브리오균의 증식을 억제 하는 결과를 나타내었다. 이와 같은 결과를 통해 4가지 천연물의 메탄올 추출물은 바닷물과 해산물에 존재하는 패혈증비브리오균에 대해 뛰어난 항균효과를 나타내면서 인체에는 무해한 천연소독제로 응용할 수 있을 것으로 판단된다.

• 한국임상약학회지
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• 제18권2호
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• pp.114-119
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• 2008

Alendronate is a bisphosphonate that selectively inhibits osteoclast-mediated bone resorption. Dosing convenience is an important element for the enhancement of patient compliance and the effective management of osteoporosis. The purpose of this study was to compare the effectiveness and compliance among alendronate pharmaceutical products (oral once-weekly alendronate 70 mg, daily alendronate 10 mg, and once-weekly alendronate 70 mg with Vitamin $D_3$ 2800 IU) in terms of the change in bone mineral density (BMD), biochemical markers, and compliance estimates. A retrospective chart review was conducted in patients with osteoporosis who received alendronate 70 mg (Group 1), alendronate 10 mg (Group 2), or alendronate 70 mg with Vitamin D3 2800 IU (Group 3) at the endocrinology department of a hospital in Korea from Jan. 1, 1998 to Mar. 31, 2008. The primary endpoints were the increases in spine antero-posterior BMD T-score and femur trochanter BMD T-score, and the compliance of alendronate products. Secondary endpoints included changes in bone turnover-related biochemical markers including bone-specific alkaline phosphatase, urinary N-terminal telopeptides (NTX) and osteocalcin, and in serum vitamin $D_3$ concentration. There was no statistical difference in the BMD increase among the three alendronate products; spine BMD T-score increased by $0.49{\pm}0.52$, $0.39{\pm}0.48$ and $0.50{\pm}0.41$, and femur trochanter BMD T-score by $0.29{\pm}0.42$, $0.21{\pm}0.53$ and $0.24{\pm}0.22$ in Group 1, 2 and 3, respectively. With respect to the increases in femur trochanter BMD T-score and the decreases in NTX and osteocalcin, 70 mg once-weekly group was remarkably superior to 10 mg daily group (p < 0.05) The compliance of 70 mg once-weekly group was significantly higher than that of 10 mg daily treatment group (p < 0.001). In conclusion, all three alendronate treatment groups were equivalent in effectiveness, and the compliance of 70 mg once-weekly group was better than that of 10 mg daily treatment group.

• Journal of Acupuncture Research
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• 제27권1호
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• pp.75-86
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• 2010

Objectives : We developed and proposed a guideline for safety and performance assessment of electric moxibustion apparatus (class II medical device). Methods : We drafted the guideline for safety and performance assessment of electric moxibustion apparatus by referring the existing standards, guidelines and measurement data from commercially available products. Temperature characteristics such as maximum temperature and ramp time, and physical characteristics such as weight, noise and diameter were measured. User friendliness was also evaluated for commercial devices. Results : This guideline only can be applied to the electric moxibustion apparatus where moxa is being heated by electricity for medical proposes. Maximum temperature of higher than $50^{\circ}C$ can be achieved mostly. Ramp rate of temperature seems to be reliable. Control of temperature is needed to be improved. Moxa and its derivative products seem to be regulated for reliable temperature performance for clinical application. Requirements for design and development of electric moxibustion apparatus are suggested : temperature indicator, temperature control and its accuracy, safety measure, surge protection, user friendliness and instruction for use (IFU). Design recommendation of the reduction of noise level and energy loss are suggested for better products. Conclusions : We proposed a guideline for safety and performance assessment of electric moxibustion apparatus to improve the quality of relating products and aid their commercialization by aiming higher industrial competitiveness of the medical device sectors in Korea. Discussion with related institutes such as industry, academy and government is further required. Public hearings also need to be held prior to the establishment of a final guideline and standard.

• 한방안이비인후피부과학회지
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• 제32권2호
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• pp.24-58
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• 2019

Objectives : The purpose of this study is to confirm the Efficacy and Safety of "Functional cosmetics containing Humulus japonicus Extract" on dry skin due to mild atopic dermatitis. Methods : A total of 48 patients who visited Semyung Oriental Medical Center from March 20th, 2018 to July 5th, 2018 were included in the study. In this study, the patients were treated with Functional cosmetics containing Humulus japonicus Extract and positive control group. For 6 weeks of gross examination, instrumental assessment were made before and after the study to evaluate how well the products for treatment group with positive control products for control group in recovering the dry skin barriers by mild atopic dermatitis. Results : 1. In the primary endpoint, Skin Hydration showed a statistically significant increase and Transepidermal Water Loss(TEWL) showed a statistically significant decrease in treatment group between Baseline and 6 weeks. 2. In the secondary endpoint, Skin Hydration showed a statistically significant increase in treatment group between Baseline and 3 weeks, but TEWL showed no statistical significance. 3. In the secondary endpoint, Skin Hydration showed a statistically significant increase in treatment group between 3 weeks and 6 weeks, but TEWL showed no statistical significance. 4. In the secondary endpoint, Change of Skin Hydration and TEWL between treatment and control group showed a statistical significance in 6 weeks. 5. In the secondary endpoint, Change of Skin Hydration of 1cm below the medial aspect of the elbow between treatment and control group showed a statistical significance in 3 weeks. 6. In the secondary endpoint, Change of Skin Hydration between treatment and control group showed a statistical significance in 3 weeks and 6 weeks except Center between the medial aspect of the elbow and the wrist in 3 weeks, and Change of TEWL between treatment and control group showed a statistical significance in 6 weeks. 7. To evaluate the safety of the products for the human body, Adverse events, EASI Score, Itching Symptoms Assessment, vital sign check were conducted; There were no severe adverse events during this study. And both experimental group and control group showed no abnormal level. Therefore, it is suggested that products, if used for certain period, should be safe for the human body. Conclusions : According to the above experiments, it is suggested that "Functional cosmetics containing Humulus japonicus Extract" should be effective for dry skin due to mild atopic dermatitis.

• 대한화학회지
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• 제51권4호
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• pp.352-355
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• 2007

Efficient stereoselective synthesis of α,β-Unsaturated acids, α-Cyanoacrylonitriles and α-Cyanoacrylates has been carried out in the presence of NaHSO4·SiO2 under solvent?free conditions with an E-geometry.

• Journal of Microbiology and Biotechnology
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• 제23권11호
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• pp.1544-1553
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• 2013

Despite the importance of acetate kinase in the metabolism of bacteria, limited structural studies have been carried out on this enzyme. In this study, a three-dimensional structure of the Escherichia coli acetate kinase was constructed by use of molecular modeling methods. In the next stage, by considering the structure of the catalytic intermediate, trifluoroethanol (TFE) and trifluoroethyl butyrate were proposed as potential inhibitors of the enzyme. The putative binding mode of these compounds was studied with the use of a docking program, which revealed that they can fit well into the enzyme. To study the role of these potential enzyme inhibitors in the metabolic pathway of E. coli, their effects on the growth of this bacterium were studied. The results showed that growth was considerably reduced in the presence of these inhibitors. Changes in the profile of the metabolic products were studied by proton nuclear magnetic resonance spectroscopy. Remarkable changes were observed in the quantity of acetate, but other products were less altered. In this study, inhibition of growth by the two inhibitors as reflected by a change in the metabolism of E. coli suggests the potential use of these compounds (particularly TFE) as bacteriostatic agents.

• 한국잠사학회:학술대회논문집
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• 한국잠사학회 2003년도 제46회 춘계 학술연구 발표회
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• pp.46-46
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• 2003

Three phospholiplds (4 6) and three aromatic amines (1 3) were obtained from the methanol extract of Bombycis corpus. Based on spectral data, their structures have been elucidated as nicotiamide(1), cytidine(2), adenine(3), 1-O-(9Z-octadecenoyl)-2-O-(8Z, llZ-octadecadienoyl)-sn-glycero-3-phosphorylcholine(4), 1,2-di-O-hexadecanoly-sn-glycero-3-phosphorylcholine(5) and 1,2-di-O-9Z-octadecenoly-sn-glycero-3-phosphorylcholine(6). (omitted)

• 대한한의학회지
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• 제33권3호
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• pp.147-159
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• 2012

Objectives: Systems related to the production, authorization, and listing for insurance of herbal medicine products were compared between South Korea and Taiwan to illuminate herbal medicine products system issues in South Korea. Methods: Papers, and laws and policies related to the production, authorization, and listing for insurance of herbal medicine products in South Korea and Taiwan are analyzed to create the primary documents. The documents from South Korea were screened with the advice of a specialist, while those from Taiwan have been verified through local investigation and with the help of a related specialist. The screened documents were then compared and analyzed in the order of the systems related to the production, authorization, and listing for insurance of herbal medicine products. Results: The systems related to the production of herbal medicine products satisfy GMP requirements in both countries, while Taiwan has more specialized systems related to the production of herbal medicine products and a more strict authorization program as compared to South Korea. While South Korea has most of the herbal medicine products classified as non-prescription drugs, Taiwan has them as prescription drugs. And while South Korea does not allow new herbal medicine products to be listed for insurance, Taiwan allows for once-a-year application toward listing for insurance. Conclusions: In order to ensure the safe and effective use of herbal medicine products, systems related to the production, authorization, and listing for insurance of herbal medicine products are to be established, while the categorization of medicine products principally used by Korean medicine doctors should be prepared. Furthermore, prescription by a Korean medicine doctor for new drugs made with natural products and their listing for insurance need to be encouraged.

• 대한한의학회지
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• 제35권3호
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• pp.135-154
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• 2014

Purpose: There is an issue in applying various principles introduced in established Korean medical classics to "Pharmaceuticals Approval, Notification and Review" of "herbal medicinal preparations" and "new drugs from natural products" that are used for western forms of medical treatment. Thus, an analysis of the origin, purpose, and application of established Korean medical classics in the Korean Pharmaceutical Affairs Act is essential. Methods: We collected data regarding the origin, purpose, and application of established Korean medical classics in the Korean Pharmaceutical Affairs Act, and classified them by periodical change and subjects. Results: Established Korean medical classics are applied as follows: 1) as criteria for Korean medicine distributors' sales of mixed herbal drugs (Pharmaceutical Affairs Act; since 1953), 2) as official compendiums for pharmacists' preparation of Korean medicine (Ministry of Health and Welfare's authoritative interpretation; from early 1970s to 1993), 3) as standards for oriental pharmacists' quality measurement of preparations (notification of the Ministry of Health and Welfare; since 1995), 4) as criteria for "Pharmaceuticals Approval, Notification and Review" of herbal medicinal preparations and crude drug preparations (notifications regarding drug approval process by the Ministry of Health and Welfare and the Ministry of Food and Drug Safety; since 1978), and 5) as standards for the quality of materials of health functional food (from 2004 to 2011). Conclusion: The application of Korean medical classics has been closely related with the change of the laws, regulations, and systems that are relevant to Korean medicine, and it seems to be more favorable for pharmacists than oriental pharmacists. Meanwhile, regulations that apply prescriptions that are recorded in Korean medical classics - dosage, indications, and preparation methods - as criteria for the approval of crude drug preparations for western medical treatment should be abolished.