• Title/Summary/Keyword: new drugs

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Industry 4.0 - A challenge for variation simulation tools for mechanical assemblies

  • Boorla, Srinivasa M.;Bjarklev, Kristian;Eifler, Tobias;Howard, Thomas J.;McMahon, Christopher A.
    • Advances in Computational Design
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    • v.4 no.1
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    • pp.43-52
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    • 2019
  • Variation Analysis (VA) is used to simulate final product variation, taking into consideration part manufacturing and assembly variations. In VA, all the manufacturing and assembly processes are defined at the product design stage. Process Capability Data Bases (PCDB) provide information about measured variation from previous products and processes and allow the designer to apply this to the new product. A new challenge to this traditional approach is posed by the Industry 4.0 (I4.0) revolution, where Smart Manufacturing (SM) is applied. The manufacturing intelligence and adaptability characteristics of SM make present PCDBs obsolete. Current tolerance analysis methods, which are made for discrete assembly products, are also challenged. This paper discusses the differences expected in future factories relevant to VA, and the approaches required to meet this challenge. Current processes are mapped using I4.0 philosophy and gaps are analysed for potential approaches for tolerance analysis tools. Matching points of simulation capability and I4.0 intents are identified as opportunities. Applying conditional variations, incorporating levels of adjustability, and the un-suitability of present Monte Carlo simulation due to changed mass production characteristics, are considered as major challenges. Opportunities including predicting residual stresses in the final product and linking them to product deterioration, calculating non-dimensional performances and extending simulations for process manufactured products, such as drugs, food products etc. are additional winning aspects for next generation VA tools.

Inhibitory effects of a new iridoids, patridoid I and II on TNF, iNOS and COX-2 expression in cultured murine macrophages

  • Ju, Hye-Kyung;Jung, Hye-Jin;Moon, Tae-Chul;Lee, Eun-Kyung;Baek, Suk-Hwan;An, Ren-Bo;Bae, Ki-Hwan;Son, Kun-Ho;Kim, Hyun-Pyo;Kang, Sam-Sik;Chang, Hyeun-Wook
    • Proceedings of the PSK Conference
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    • 2002.10a
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    • pp.321.2-321.2
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    • 2002
  • Possible role of anti-inflammatory effects of a new iridoids, patridoid I. II and II-A which were isolated from Patrinia saniculaefolia. examined by assessing their effects on tumor necrosis factor $\alpha$ (TN F$\alpha$) and 2 enzymes, inducible nitric oxide synthase (iNOS) and cyclooxygenase-2 (COX-2) in the lipopolysaccaride (LPS)-stimulated murine macrophage-like cell line RAW 264.7. Among them. patridoid II consistently inhibited the production of TNF$\alpha$ and NO production in a dose dependent manner. But patridoid I and patrioid ll isomer palrioid ll-A. these compounds very weakly inhibited NO producion. Moreover. treatment of macrophage with these compounds, the decrease in NO products was accompanied by a decrease in iNOS protein level as assessed by Western Blot. But these compounds did not affect COX-2 protein expression in LPS-stimulated macrophage. Our results suggest that patridoid ll could become a leading compound for developing a novel of anti-inflammalory drugs.

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A Study on the Countermeasures Taken By the Korean Healthcare and Life Sciences Industry Regarding U.S. Import Refusals: Focus on the Analysis of FDA Violation Codes (한국 바이오헬스 산업의 미국 수입거부 대응 방안 연구 : FDA 위반코드 분석을 중심으로)

  • Yu-Han Lee;Hag-Min Kim
    • Korea Trade Review
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    • v.48 no.3
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    • pp.131-150
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    • 2023
  • The purpose of this study was to find a countermeasure to the U.S. import refusals for the Korean healthcare and life sciences industry. To this end, an analysis of trends during the pandemic was conducted using the KITA Border Rejection Database, which includes information on items and types of import refusals. The reason for rejection was also analyzed according to the FDA violation codes. The degree of countermeasure for import refusals was identified by measuring the unit rejection rate (URR). The results of the analysis showed that the major U.S. import refusals for the Korean healthcare and life sciences industry had expanded from contact lenses to COVID-19 diagnostic kits and drugs after the pandemic broke out. The major reasons for import refusals were non-compliance with the Predicate Device and Drugs Act and non-approval by the FDA for products and facilities. On the other hand, the unit rejection rate (URR) of major items in the Korean healthcare and life sciences industry was measured higher than the industry average. The results therefore showed a low level of response to U.S. import refusals. The results of the analysis of reasons for import refusals by item according to FDA violation codes were as follows. First of all, the main violation for contact lenses and COVID-19 diagnostic kits corresponded to misbranding. This was often due to the fact that Korean companies did not provide the relevant notices and information required by the FDA. Many cases also failed to demonstrate a substantial equivalency compared to predicate devices already on the market. On the other hand, applications for new unapproved drugs were not accepted as they had yet to pass relevant regulations that would prove their safety and efficacy. In conclusion, import refusals for the Korean healthcare and life sciences industry were found to be closely related to technical barriers to trade (TBT).

Pulmonary Resection Combined with Isoniazid-and Rifampin-based Drug Therapy for Patients with Multidrug-resistant Tuberculosis (다제내성 폐결핵 환자에서 폐절제술 후 일차 항결핵제 치료)

  • Park, Seung-Kyu;Kim, Jin-Hee;Kim, Jun-Ho
    • Tuberculosis and Respiratory Diseases
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    • v.59 no.2
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    • pp.179-185
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    • 2005
  • Background : To evaluate the clinical efficacy of pulmonary resection combined with first-line antituberculous drug therapy in patients with well-localized, cavities-containing pulmonary multidrug-resistant tuberculosis (MDR-TB). Method : From February 1998, seventeen patients with well-localized, cavities-containing pulmonary MDR-TB were enrolled and followed prospectively up to December 2004. After radical pulmonary resection, the patients were treated with antituberculous drugs comprising of isoniazid (H), rifampin (R), pyrazinamide (Z), ethambutol (E), and streptomycin (S) (3HERZS/3HERS/6HER). Results : All recovered isolates of M. tuberculosis were resistant to both isoniazid and rifampin, and to a mean of 4.8 antituberculous drugs (range, 2 to 7 drugs). Surgical procedures included lobectomy (13 patients), lobectomy plus segmentectomy (3 patients), and pneumonectomy (1 patient). The median time for postoperative sputum smear and culture conversion was 2 days (range, 1 to 23 days). Fifteen (94%) patients had durable cures (mean follow-up period, 39.0 months). One patient failed to convert her sputum and was successfully switched to second-line therapy; one patient developed active disease again almost 7 years later, likely due to re-infection with a new M. tuberculosis strain. Conclusion : Radical resection combined with administration of first-line antituberculous agents was effective in patients with well-localized, cavities-containing pulmonary MDR-TB.

Application of Exosome for Diagnosis and Treatment of Diseases in the Central Nervous System (중추신경계 질환의 진단과 치료를 위한 엑소좀의 활용)

  • Jia Bak;Yun-Sik Choi
    • Journal of Life Science
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    • v.33 no.9
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    • pp.754-765
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    • 2023
  • Exosomes are a type of extracellular vesicle containing proteins and messenger and microRNAs; they are secreted by all cell types. Once released, exosomes are selectively taken up by other cells adjacent or at a distance, releasing their contents and reprogramming the target cells. Since exosomes are natural vesicles produced by cells as small sizes, it is generally accepted that exosomes have a non-toxic nature and non-immunogenic behaviors. Recently, exosomes have elicited scientific attention as drug delivery vehicles to the central nervous system. The central nervous system has a blood-brain barrier that makes it difficult for drugs to penetrate. Thus, the blood-brain barrier has been a major obstacle to the development of drugs for treating neurodegenerative diseases. However, accumulating evidence suggests that exosomes can cross the blood-brain barrier primarily through transcytosis. Consequently, exosomes are expected to become a new delivery vehicle that can cross the blood-brain barrier and deliver drugs into the brain parenchyma. In addition, since different types of exosomes are secreted depending on the cell type and disease state, exosomes can also be utilized as biomarkers for the diagnosis of diseases in the central nervous system. In this review, we summarized recent research trends on exosomes, including clinical trials as biomarkers and treatment options for diseases in the central nervous system.

In vitro Evaluation of Antidermatophytic Activity of Egyptian Bee Propolis in Combination with Plant Essential Oils in Sheep Hoof Plate: An Experimental Model

  • Mahmoud, Yehia A.G.
    • Mycobiology
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    • v.31 no.2
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    • pp.99-104
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    • 2003
  • Bee propolis ethanolic extract with some plant essential oils was investigated for its antidermatophytic properties. The tested plant essential oils included jasmine, clove, lemon, Arabian jasmine, mint, rosa, olive and basil. The antidermatophytic activity has been compared to Naftifine-HCl and Clotrimazole used for dermatophyte treatment. Experimental model has been tested using sheep hoof plate for the in vitro tests to stimulate human nails. Mint, clove and basil with 4 mg/ml of bee propolis have a comparable efficacy to those of Naftifine-HCl and Clotrimazole. There is a great necessity for new effective low price and safe antidermatophyte agents to avoid recurrent infection. Propolis synergistic could be of great importance with essential oils of plants in dermatophyte therapy.

Strategy to Overcome Drug Resistance That Develops during Treatment of Chronic Hepatitis B in Children

  • Hong, Suk Jin;Choe, Byung-Ho
    • Pediatric Gastroenterology, Hepatology & Nutrition
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    • v.15 no.2
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    • pp.63-73
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    • 2012
  • Development of antiviral resistance to lamivudine is the most important factor for the treatment failure. It is necessary to establish proper guidelines to overcome drug resistance for children with chronic hepatitis B. Primary treatment with lamivudine should be considered if patients are in immune-clearance phase and have persistently elevated ALT levels more than twice the upper limit of normal value. Before initiating the therapy, careful consideration of the patient's status is required to exclude abnormal liver function tests due to other causes. The treatment option should be carefully decided to suppress the viral replication effectively. To obtain good compliance, clinicians should educate patients and their parents. Appropriate monitoring for virologic breakthrough and genotypic resistance is important in deciding to change the treatment plan. Sequential monotherapy should be avoided and a combination of drugs in other categories is recommended. New antiviral agents, such as entecavir and tenofovir, which have high potency and high genetic barrier, are soon expected to be available for use with children.

Recent Advances in Tuberculosis and Nontuberculous Mycobacteria Lung Disease

  • Park, Jae Seuk
    • Tuberculosis and Respiratory Diseases
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    • v.74 no.6
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    • pp.251-255
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    • 2013
  • Tuberculosis (TB) is one of the largest health problems in the world today. And the incidence of nontuberculous mycobacteria (NTM) lung disease appears to be increasing worldwide. Recently, an automated, nucleic acid amplification assay for the rapid detection of both Mycobacterium tuberculosis and rifampin resistance was developed (Xpert MTB/RIF). And fixed-dose combinations of anti-TB drugs and linezolid have been introduced in the treatment of TB. And new NTM species, named Mycobacterium massiliense, which is very closely related to Mycobacterium abscessus was reported. In this review, these recent advances in the diagnosis and treatment of TB and clinical characteristics of M. massiliense lung disease are discussed.

The Role of Regulatory T Cells in Cancer

  • Ha, Tai-You
    • IMMUNE NETWORK
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    • v.9 no.6
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    • pp.209-235
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    • 2009
  • There has been an explosion of literature focusing on the role of regulatory T (Treg) cells in cancer immunity. It is becoming increasingly clear that Treg cells play an active and significant role in the progression of cancer, and have an important role in suppressing tumor-specific immunity. Thus, there is a clear rationale for developing clinical strategies to diminish their regulatory influences, with the ultimate goal of augmenting antitimor immunity. Therefore, manipulation of Treg cells represent new strategies for cancer treatment. In this Review, I will summarize and review the explosive recent studies demonstrating that Treg cells are increased in patients with malignancies and restoration of antitumor immunity in mice and humans by depletion or reduction of Treg cells. In addition, I will discuss both the prognostic value of Treg cells in tumor progression in tumor-bearing hosts and the rationale for strategies for therapeutic vaccination and immunotherapeutic targeting of Treg cells with drugs and microRNA.

Design, Synthesis, and Antimicrobial Activity, of New 1,4-disubstituted Octahydroquinoxaline-2,3-dione Derivatives

  • Hussein, Mostafa A.
    • Bulletin of the Korean Chemical Society
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    • v.32 no.5
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    • pp.1511-1518
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    • 2011
  • A series of 1,4-disubstituted octahydroquinoxaline-2,3-dione derivatives was prepared through two steps reaction. The latter involves the formation of N,N-disubstituted cyclohexane-1,2-diamine derivatives (la-j) through reductive alkylation of 1,2-cyclohexanediamine with different aldehydes in presence of sodium cyanoborohydride. Fusion of compounds (1a-j) with diethyl oxalate affording the target compounds (2a-j). Elucidation of structures of compounds (2a-j) was based upon different spectral data as well as the elemental methods of analyses. In addition, mass spectrometry and X-ray diffraction analyses were carried out. Moreover, the lipophilicity of the target compounds as expressed from the Clog P. Most of the test compounds (2a-j) showed weak to moderate antibacterial and antifungal activities against most of the used bacterial and fungal strains in comparison to chloramphenicol and clotrimazole as reference drugs respectively.