• 제목/요약/키워드: Pharmaceutical Market

검색결과 189건 처리시간 0.026초

국립한의대 설치 필요성에 대한 일반인의 인식도 조사 (General Survey on the Necessity of Establishment School of Oriental Medicine at the National University Level)

  • 이선동;안상우;권영규;고성규;신상우;배종면
    • 대한예방한의학회지
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    • 제9권1호
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    • pp.37-48
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    • 2005
  • Subjects in this study comprised of general public (907), high school students (772), individuals associated with Oriental medicine (660), and 60 majoring in western medicine, totalling 2,413 individuals. Survey was conducted on the necessity of establishing Oriental medicine school at the national university level and the following result were obtained: - 78.3% (1847 individuals) were in favor of establishing Oriental medicine school at the national university level. - For the validity of establishment, responders expressed opinions of standard and virtuous education, higher quality education, standardized practice, research on difficult to cure diseases, and obtaining competitiveness in the world market. - One to three schools were considered as an appropriate number of schools with less than 80 students per class, Class size may be adjusted from existing schools (52.5% favored decrease in size) and (46.3% favored increase in size). - Educational and research facilities must be accopanied with schools of Oriental medicine as well as clinical training facilities, herbal pharmaceutical research centers, and fundamental medical centers. - Many favored 6 year curriculum as the most appropriate system and the school of Oriental medicine should be established within the university. Based on the information gathered in this survey, we may recognize the limitations of Oriental medicine schools at the private institutional level and support the establishment of Oriental medicine schools at th national university level. This establishment may play as a steeping stone for advancement in education, standardization of research and treatment, and commercialization of Oriental medicine of benefit the general public.

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의료기기의 결함으로 인한 손해배상책임과 미국 연방법 우선 적용 이론에 관하여 (The Liability for Unsafe Medical Product and The Preemption Clause of Medical Device Act)

  • 김장한
    • 의료법학
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    • 제15권2호
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    • pp.63-89
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    • 2014
  • In 1976, the Dalkon Shield-intrauterine device injured several thousand women in U.S.A. which caused the changes of medical deivce regulation. The Medical Device Regulation Act or Medical Device Amendments of 1976 (MDA) was introduce. As part of the process of regulating medical devices, the MDA divides medical devices into three categories. The class II, and III devices which have moderate harm or more can use the section 510 (k), premarket notification process if the manufacturer can establish that its device is "substantially equivalent" to a device that was marketed before 1976. In 21 U.S.C. ${\S}$ 360k(a), MDA introduced a provision which expressly preempts competing state laws or regulations. After that, the judicial debates had began over the proper interpretation and application of Section 360(k) In February 2008, the U.S. Supreme Court ruled in Riegel v. Medtronic that manufacturer approved by the Food and Drug Administration (FDA)'s pre-market approval process are preempted from liability, even when the devices have defective design or lack of labeling. But the Supreme Court ruled in Medtronic Inc. v. Lora Lohr that the manufactures which use the section 510 (k) process cannot be preempted and in Bausch v. Stryker Corp. that manufactures which violated the CGMP standard are also liable to the damage of patient at the state courts. In 2009, the Supreme Court ruled in Wyeth v. Levine that patients harmed by prescription drugs can claim damages in state courts. This may cause a double standard between prescription drugs and medical devices. FDA Preemption is the legal theory in the United States that exempts product manufacturers from tort claims regarding Food and Drug Administration approved products. FDA Preemption has been a highly contentious issue. In general, consumer groups are against it while the FDA and pharmaceutical manufacturers are in favor of it. This issues also influences the theory of product liability of U.S.A. Complete immunity preemption is an issue need to be more declared.

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Effectiveness of the Anti-adhesive Agent Protescal after Arthroscopic Rotator Cuff Repair: A Retrospective Study

  • Chung, Pill Ku;Yoo, Jae Chul;Jeong, Jeung Yeol
    • Clinics in Shoulder and Elbow
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    • 제20권1호
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    • pp.3-9
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    • 2017
  • Background: Many hyaluronic acid (HA)-based anti-adhesive agents have been commercialized for clinical use in the pharmaceutical market. But their efficacy in arthroscopic rotator cuff repairs remains elusive. To determine their efficacy, we performed a comparative analysis of the effects of two hyaluronate/carboxymethylcellulose (CMC)-based anti-adhesive agents, Protescal and Guardix. Methods: We recruited a total of 256 patients who had received an arthroscopic rotator cuff repair at our hospital between January 2014 and March 2015. Among them, 96 patients fulfilled the study's selection criteria and were enrolled as the final population sample. Thirty patients who had received a postoperative injection of Protescal were allocated into Group A. Another 30 patients who had received a postoperative injection of Guardix were allocated into Group B. As controls, 36 patients who did not receive any injection were allocated into Group C. The patients included in this study were aged between 19 and 75 years. For the clinical assessment, we measured the following clinical parameters-the visual analogue scale for pain (PVAS), the American Shoulder and Elbow Surgeons (ASES) score, and the constant score, as well as passive range of motions (ROMs)-at three time-points (preoperatively, 2-month postoperatively, and 6-month postoperatively). Results: We found that Group A compared to Group B tended to show a swifter recovery in passive anterior elevation and in internal rotation by the 2-month postoperative follow-up, but the differences were not statistically significant. Conclusions: We found that the effects of HA/CMC-based injections were minimal after arthroscopic rotator cuff repairs.

신약 개발을 위한 참당귀(Angelica gigas Nakai) 추출 Decursin과 Decursinol Angelate의 약리 작용 (Pharmacological Effect of Decursin and Decursinol Angelate from Angelica gigas Nakai)

  • 손추영;백인환;송규용;강재선;권광일
    • 약학회지
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    • 제53권6호
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    • pp.303-313
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    • 2009
  • Traditionally, Cham dang-gui (Angelica gigas Nakai) is one of the most popular herbal medicines in Asian countries including Korea. A. gigas has been used as a functional food product for treatment anemia, women's health care, a sedative, an anodyne or a tonic agent. Decursin and decursinol angelate isolated from the roots of A. gigas are pyranocoumarin compounds. Recently, as the global herbal medication market is increasing, investigations about pharmacological effects of decursin and decursinol angelate are rapidly increasing. We summarized previous studies about pharmacological effects of decursin and decursinol angelate, and reviewed relation with pharmacological effects of decursin and decursinol angelate on human disorder, focused on the approach for new drug development. Pharmacological effects of decursin and decursinol angelate were classified as anti-tumor activity, anti-bacterial activity, improvements of the circulating system, inhibition of cytochrome P-450 activity, anti-inflammation activity, anti-oxidant activity and cognitive-enhancing activites. The activity of A. gigas with improvement of the circulating system may have wide therapeutic potential for circulatory diseases, including diabetes, hyperlipidemia and atherosclerosis. Also, anti-inflammation activity A. gigas may be beneficial for the treatment and prevention of asthma, atopic dermatitis and rheumatism arthritis. This relation could potentially lead to the development of herbal new drugs. In order to development a new drug containing decursin and decursinol angelate, it is also necessary to consider the safety profile, and the information in this review would contribute to development a new drug from herbal medicine.

HIMALAYAN MEDICINAL RESOURCES: PRESENT AND FUTURE. A CASE STUDY: ANTIDIABETIC ACTIVITY OF SHILAJIT

  • Basnet, Purusotam
    • 한국자원식물학회:학술대회논문집
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    • 한국자원식물학회 2001년도 The 8th International Symposium
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    • pp.20-33
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    • 2001
  • A major portion of drugs used in Ayurvedic system of medicine which has been practiced since the early human civilization in Indian subcontinent were of plant origin. It should be noted that 70% of the population in this region depends on Ayurveda for their medical treatment and 60% of the drug resources are obtained from the Himalayan region. Therefore, Nepal becomes a potential source of plant drug resource since it occupies a major portion of the Himalaya. In the present paper, in general a current status of medicinal plant resources of Himalayan region especially Nepal will be discussed. In addition to this, a typical example of antidiabetic activity of Shilajit will be taken for the discussion. Shilajit is one of the crucial elements in several formulations including those of Rasayana, a therapy in Ayurveda, which has been practiced in the prevention of ageing and mental disorder. Although, Shilaiit is widely used for the treatment of diabetes, no satisfactory scientific reports are available up to now. The crude Shilajit in the market is a dark brown or black rock-like substance collected from the Himalayan region with a strong smell of cow's stale urine. In our studies, Shilajit (collected in the central Himalayan region) prevented the diabetes in nonobese diabetic (NOD) mice model. Shilajit also prevented the diabetes in the rats against the action of multiple low-dose (10 ㎎/㎏, i.v., 5 times) of streptozotocin. On the other hand, Shilajit did not show antioxidative activity. The preventive action of Shilajit on diabetes is mainly focused on the Th1 and Th2 cell activities, since Th2 cells activity was found to be significantly upregulated. Shilajit, however, showed a mild action in controlling the blood sugar level in young, old, and mild diabetic rats, but not in the severe diabetic rats. It also stimulated the nitric oxide production in macrophages. Based on these evidences, the antidiabetic activities of Shilajit appear to be immunomodulative probably by protecting or strengthening insulin-producing b-cells In the pancreas. further systematic research on constituents of Shilajit and its quality evaluation is necessary to enable the use of natural medicines in the treatment of diabetes.

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서울시내 유통 중인 계지의 지표성분 함량분석 (Analysis of Cinnamic Acid, Cinnamaldehyde and 2-Methoxycinnamaldehyde in Cinnamomi Ramulus on the Market in Seoul by HPLC)

  • 이정숙;이성득;황광호;김희순;유인실;한기영;채영주
    • 약학회지
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    • 제57권4호
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    • pp.235-240
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    • 2013
  • For the quality control of traditional herbal medicine, Cinnamomi Ramulus, simultaneous determination of cinnamic acid, cinnamaldehyde, and 2-methoxycinnamaldehyde was established by using a high performance liquid chromatographic (HPLC) method with diode array detector. To separate three constituents, Eclipse XDB C18 ($5{\mu}m$, $4.6{\times}250mm$) was used with 0.1% acetic acid and acetonitrile. Validation of the chromatography method was evaluated by linearity, recovery, and precision test. Calibration curve of standard components showed excellent linearity ($R^2$ >0.9999). A simple and efficient method by HPLC was developed to evaluate the quality of traditional herbal medicines made from Cinnami Ramulus. Three major bioactive ingredients in 30 samples that are from China(8) and Vietnam(22) were separated and quantified.

Green Synthesis to Develop Iron-Nano Formulations and Its Toxicity Assays

  • Kulkarni, Smital;Mohanty, Nimain;Kadam, Nitin N.;Swain, Niharika;Thakur, Mansee
    • 대한약침학회지
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    • 제23권3호
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    • pp.165-172
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    • 2020
  • Objectives: In the past few years, herbal medicines have gained popularity over synthetic drugs because of their natural source and minimal side effects which has led to a tremendous growth of phytopharmaceuticals usage. With the development of nanotechnology, it provides alternative approaches to overcome several limitations using nano-formulations. In spite of considerable quantity of antianemic preparations with different iron forms available, currently additives are used and represented in modern pharmaceutical market. Iron deficiency anemia is a major global public health problem which particularly affects pregnant women, children and elderly persons. The situation is complicated because of disadvantages and drug side effects from existing antianemic medicines. There is a great demand for the development of new antianemic preparations. Green synthesis of iron oxide nanoparticles, possess high potential in this field. Methods: Our study focuses on developing green synthesis of iron oxide nanoparticles (IONPs) of 10-50 nm with spherical shape where different dosages were used -1 mg/kg, 10 mg/kg and 100 mg/kg for exposure in Wistar albino female rats for 28 days. The toxicity was assessed using various parameters such as measurements of the rat body and organ mass, hematology, biochemical evaluation and histopathological examinations. Results: No significant differences were observed in body and organ weights. Hematological indices also indicated no significant differences whereas biochemical factors showed increase in levels of direct bilirubin and globulin of medium as well as high dose and SGPT levels were increased only in high dose. The major organs (heart, kidney and liver) showed histopathological alterations in 10 and 100 mg/kg whereas brain showed only in 100 mg/kg. Conclusion: The toxicity of IONPs was found to be more significant when the concentration was increased; however, low doses can be used for further investigation as an antianemic preparation.

From Bench to Market: Preparing Human Pluripotent Stem Cells Derived Cardiomyocytes for Various Applications

  • Moon, Sung-Hwan;Bae, Daekyeong;Jung, Taek-Hee;Chung, Eun-Bin;Jeong, Young-Hoon;Park, Soon-Jung;Chung, Hyung-Min
    • International Journal of Stem Cells
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    • 제10권1호
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    • pp.1-11
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    • 2017
  • Human cardiomyocytes (CMs) cease to proliferate and remain terminally differentiated thereafter, when humans reach the mid-20s. Thus, any damages sustained by myocardium tissue are irreversible, and they require medical interventions to regain functionality. To date, new surgical procedures and drugs have been developed, albeit with limited success, to treat various heart diseases including myocardial infarction. Hence, there is a pressing need to develop more effective treatment methods to address the increasing mortality rate of the heart diseases. Functional CMs are not only an important in vitro cellular tool to model various types of heart diseases for drug development, but they are also a promising therapeutic agent for cell therapy. However, the limited proliferative capacity entails difficulties in acquiring functional CMs in the scale that is required for pathological studies and cell therapy development. Stem cells, human pluripotent stem cells (hPSCs) in particular, have been considered as an unlimited cellular source for providing functional CMs for various applications. Notable progress has already been made: the first clinical trials of hPSCs derived CMs (hPSC-CMs) for treating myocardial infarction was approved in 2015, and their potential use in disease modeling and drug discovery is being fully explored. This concise review gives an account of current development of differentiation, purification and maturation techniques for hPSC-CMs, and their application in cell therapy development and pharmaceutical industries will be discussed with the latest experimental evidence.

커큐민이 건강에 미치는 효과 - 재평가 (Effects of curcumin on human health - A reassessment)

  • 김대옥;이창용
    • 한국식품과학회지
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    • 제53권5호
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    • pp.509-513
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    • 2021
  • 커큐민은 산화방지능, 항염증, 항우울, 항균, 항종양 등의 다양하고 유익한 생리학적 활성이 있는 것으로 알려져 있다. 또한, 커큐민은 면역조절, 대사조절, 신경보호 효과도 가지고 있다. 지난 10년 동안 13,000편 이상의 연구 논문에서 커큐민의 건강상 이점에 대한 연구가 발표되었음에도 불구하고, 아직까지 전 세계 어느 나라에서도 커큐민을 의약품으로 시장에 출시하지 못하고 있다. 긍정적인 결과가 많음에도, 건강상의 이점을 내세우는 대부분의 연구는 커큐민의 다양한 화학적 거동을 고려하지 않은 시험관실험 및 동물실험에 기반으로 하고 있다. 커큐민은 PAINS이자 IMPs 중의 하나로 알려져 있다. 따라서 엄격한 연구 설계에도 불구하고, 인체적용시험 및 임상시험은 특별한 이점을 입증할 수 없었다. 이 논문에서는 커큐민의 다면적 특성을 검토하여 커큐민의 부정적 특성이 이로운 효과와 균형을 이룰 수 있도록 하고 건강상의 이점을 더 잘 이해할 수 있는 잠재적 연구 방법을 제안하고 있다.

Prospects of omics-driven synthetic biology for sustainable agriculture

  • Soyoung Park;Sung-Dug Oh;Vimalraj Mani;Jin A Kim;Kihun Ha;Soo-Kwon Park;Kijong Lee
    • 농업과학연구
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    • 제49권4호
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    • pp.749-760
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    • 2022
  • Omics-driven synthetic biology is a multidisciplinary research field that creates new artificial life by employing genetic components, biological devices, and engineering technique based on genetic knowledge and technological expertise. It is also utilized to make valuable biomaterials with limited production via current organisms faster, more efficient, and in huge quantities. As the bioeconomic age begins, and the global synthetic biology market becomes more competitive, investment in research and development (R&D) and associated sectors has grown considerably. By overcoming the constraints of present biotechnologies through the merging of big data and artificial intelligence technologies, huge ripple effects are envisaged in the pharmaceutical, chemical, and energy industries. In agriculture, synthetic biology is being used to solve current agricultural problems and develop sustainable agricultural systems by increasing crop productivity, implementing low-carbon agriculture, and developing plant-based, high-value-added bio-materials such as vaccines for diagnosing and preventing livestock diseases. As international regulatory debates on synthetic biology are now underway, discussions should also take place in our country for the growth of bioindustries and the dissemination of research findings. Furthermore, the system must be improved to facilitate practical application and to enhance the risk evaluation technology and management system.