• Title/Summary/Keyword: FDA approved

Search Result 121, Processing Time 0.019 seconds

Anaesthetic Effect of MS-222 and Lidocaine on Abalones, Haliotis discus hannai (양식산 참전복(Haliotis discus hannai)에 대한 리도카인 및 MS-222의 박리효과)

  • Choi, Sang-Duk;Kim, Ho-Jin;Suh, Hae-Lip;Suh, Ho-Young;Yang, Moon-Ho;Hwang, Sung-Il
    • Journal of fish pathology
    • /
    • v.11 no.1
    • /
    • pp.35-41
    • /
    • 1998
  • We investigated the optimal concentration of lidocaine and MS-222 (tricaine methanesulfonate) for the exfoliation and recovery of abalone, Haliotis discus hannai in different shell lengths, for the purpose of preventing the damage of shell and muscle. However, most anaesthetics applied at present have a strong toxic effect on abalone. MS-222 is the only anaesthetic which is approved for use in food fish by FDA, and lidocaine belongs to a group of anaesthetic which are used in human medicine. These chemicals were evaluated as anaesthetic for different shell size of abalone. The response varied for different shell size groups (shell length 1, 2 and 3 cm). In this study, we suggested the result that the exfoliation and recovery time by lidocaine and MS-222 in shell length 1 cm group were more shorter than in 3 cm group. In shell length 1 cm group, the optimal concentrations of lidocaine and MS-222 for anaesthetic were 200 ppm and 100 ppm, respectively. Lidocaine and MS-222 are preferable to other conventional abalone anaesthetics since these are cheap, safe and convenient to use.

  • PDF

Differential Sensitivities of Human Multidrug-resistant Cancer Cells to BIIB021 and Modulation of Hsp90 Inhibitors by NSAIDs and Niclosamide (항암제 다제내성(MDR) 암세포의 Hsp90 저해제 BIIB021에 대한 감수성의 차이 및 NSAIDs 및 Niclosamide에 의한 Hsp90 저해제의 활성 변화)

  • Moon, Hyun-Jung;Lee, Su-Hoon;Kim, Sun-Hee;Kang, Chi-Dug
    • Journal of Life Science
    • /
    • v.28 no.10
    • /
    • pp.1212-1219
    • /
    • 2018
  • The critical role of heat shock protein 90 (Hsp90) in tumorigenesis led to the development of several first- and second-generation Hsp90 inhibitors, which have demonstrated promising responses in cancers. In this study, we found second-generation Hsp90 inhibitor BIIB021-resistant multidrug-resistant (MDR) human cancer cells, although BIIB021 was shown to be active in first-generation Hsp90 inhibitor 17-allylamino-17-demethoxygeldanamycin (17-AAG)-resistant MDR cells. MCF7-MDR and HeyA8- MDR cells were more resistant to BIIB021 than their parental counterparts, indicating that BIIB021 cannot be applicable to all cancer cells expressing MDR proteins. We revealed that dimethyl-celecoxib (DMC), one of the non-steroidal anti-inflammatory drugs (NSAIDs), potentiated cytotoxicity of BIIB021 against both BIIB021-resistant and BIIB021-sensitive MDR cells. The effectiveness of NSAIDs involving celecoxib and DMC in combination with BIIB021 led to the autophagic degradation/down-regulation of mutant p53 (mutp53) that overexpressed MDR cells and the suppression of Hsp70 induction. This resulted in sensitization of MDR cells to BIIB021. Moreover, autophagy induction by sulindac sulfide, another type of NSAID, and niclosamide, an FDA-approved anthelmintic drug, potentiated 17-AAG-mediated autophagic degradation/down-regulation of mutp53 and c-Myc, client proteins of Hsp90. Therefore, our results suggest that NSAIDs and niclosamide positively enhance the anticancer activity of Hsp90 inhibitors through an autophagic pathway. They may also be new candidates for sensitizing MDR cells to Hsp90 inhibitors.

Oncolytic Viruses - A New Era for Cancer Therapy (종양 용해성 바이러스-암 치료에서의 새 시대)

  • Ngabire, Daniel;Niyonizigiye, Irvine;Kang, Min-jae;Kim, Gun-Do
    • Journal of Life Science
    • /
    • v.29 no.7
    • /
    • pp.824-835
    • /
    • 2019
  • In recent decades, oncolytic viruses (OVs) have extensively been investigated as a potential cancer drug. Oncolytic viruses have primarily the unique advantage in the fact that they can only infect and destroy cancer cells. Secondary, oncolytic viruses induce the activation of specific adaptive immunity which targets tumor-associated antigens that were hidden during the initial cancer progression. In 2015, one genetically modified oncolytic virus, talimogene laherparepvec (T-VEC), was approved by the American Food and Drug Administration (FDA) for the treatment of melanoma. Currently, various oncolytic viruses are being investigated in clinical trials as monotherapy or in combination with preexistent cancer therapies like immunotherapy, radiotherapy or chemotherapy. The efficacy of oncolytic virotherapy relies on the balance between the induced anti-tumor immunity and the anti-viral response. Despite the revolutionary outcome, the development of oncolytic viruses for the treatment of cancer faces a number of obstacles such as delivery method, neutralizing antibodies and induction of antiviral immunity due to the complexity, variability and reactivity of tumors. Intratumoral administration has been successful reducing considerably solid tumors with no notable side effects unfortunately some tumors are not accessible (brain) and require a systemic administration of the oncolytic viruses. In order to overcome these hurdles, various strategies to enhance the efficacy of oncolytic viruses have been developed which include the insertion of transgenes or combination with immune-modulatory substances.

Application of Molecular Diagnostics Technology in the Development of a Companion Diagnostics for Malignant Solid Tumors (악성 고형암의 항암제 동반진단 기술에서 분자진단기술의 적용)

  • Kim, Jin-Hee
    • The Journal of the Korea Contents Association
    • /
    • v.19 no.3
    • /
    • pp.365-374
    • /
    • 2019
  • Unlike benign tumors, malignant tumors are capable of metastasis, easy to relapse, poor survival, and low quality of life. In Korea, here is a tendency to treat the tumors collectively according to the General Principles of Cancer Chemotherapy(GPCC) of the Health Insurance Review & Assessment Service (HIRA). But recently, companion diagnostics(CDx) is recommended rather than unilateral medication because biomarker-based molecular diagnostics is possible to predict the drug response of patients before drug treatment. Not only domestic but also overseas Food and Drug Administratio (FDA) recommends the development of the CDx system at the stage of drug development to ensure the responsiveness and safety of medicines. In this study, I focused on the necessity of CDx development direction as well as CDx development status through literature review. Furthermore I also discussed CDx types according to the molecular diagnostic technology such as immunohistochemistry (IHC), polymerase chain reaction (PCR), in situ hybridization (ISH), and next-generation sequencing (NGS) not only in the approved CDx but also in the developing one by US FDA. And I suggested the technology issue of CDx development process such as a selection of molecular diagnostics at the time of release, a clear understanding of the CDx mechanism, and a convergence of drug with CDx development. The necessity of social insurance system also was proposed for CDx development.

Development of COVID-19 Neutralizing Antibody (NAb) Detection Kits Using the S1 RBD Protein of SARS-CoV-2 (코로나 바이러스 감염증-19의 재조합 S1 RBD 단백질을 이용한 COVID-19 바이러스의 중화항체 검사 키트의 개발)

  • Choi, Dong Ok;Lee, Kang Moon
    • Korean Journal of Clinical Laboratory Science
    • /
    • v.53 no.3
    • /
    • pp.257-265
    • /
    • 2021
  • The COVID-19 virus is a β-genus virus that causes infection by mediating the angiotensin convertible enzyme 2 (ACE2) receptor, which is distributed in large numbers in the human respiratory tract. The disease requires effective post-management of antibody production by complete healers and vaccinators because there is no perfect remedy for the virus infection. This study aimed to develop recombinant proteins specifically responsive to neutralizing antibodies in clinical specimens and use them to develop a rapid diagnostic kit to diagnose neutralizing antibodies quickly and conveniently against the COVID-19 virus and confirm the possibility of commercialization through a performance evaluation. Rapid diagnostic kits using COVID-19 S1 RBD recombinant proteins can be applied to rapid diagnostic kits, with positive percentage agreement (PPA) and negative percentage agreement (NPA) of 100% and 98.3%, respectively, compared to the U.S. FDA-approved ELISA kits. If the performance of the rapid diagnostic kit is improved and neutralizing antibodies can be analyzed quantitatively using quantitative analysis equipment, it can be used as important data to predict immunity to the COVID-19 virus and determine additional vaccinations.

Fabrication of complete denture using 3D printing: a case report (3D 프린팅을 이용한 양악 총의치 제작 증례)

  • Lee, Eunsu;Park, Chan;Yun, Kwidug;Lim, Hyun-Pil;Park, Sangwon
    • The Journal of Korean Academy of Prosthodontics
    • /
    • v.60 no.2
    • /
    • pp.202-210
    • /
    • 2022
  • Recently with the advance in digital dentistry, the fabrication of dentures using computer-aided design and computer-aided manufacturing (CAD-CAM) is on the rise. The denture designed through a CAD software can be produced in a 3-dimensional manufacturing process. This process includes a subtractive processing method such as milling and an additive processing method such as 3D printing and in which it can be applied efficiently in more complex structures. In this case, complete dentures were fabricated using Stereolithography (SLA)-based 3D printing to shorten the production time and interval of visits in patient with physical disabilities due to cerebral infarction. For definitive impression, the existing interim denture was digitally replicated and used as an individual tray. The definitive impression obtained with polyvinyl siloxane impression material was including information about the inclination and length of the maxillary anterior teeth, vertical dimension, and centric relation. In addition, facial scan data with interim denture was obtained so that it can be used as a reference in determination of the occlusal plane and in arrangement of artificial teeth during laboratory work. Artificial teeth were arranged through a CAD program, and a gingival festooning was performed. The definitive dentures were printed by SLA-based 3D printer using a FDA-approved liquid photocurable resin. The denture showed adequate retention, support, and stability, and results were satisfied functionally and aesthetically.

Comparison of Laboratory Tests Applied for Diagnosing the SARS-CoV-2 Infection (SARS-CoV-2 감염의 진단에 이용되는 검사실 테스트의 비교)

  • Lee, Chang-Gun;Lee, Dongsup
    • Korean Journal of Clinical Laboratory Science
    • /
    • v.54 no.2
    • /
    • pp.79-94
    • /
    • 2022
  • Due to the highly contagious nature and severity of the respiratory diseases caused by COVID-19, economical and accurate tests are required to better monitor and prevent the spread of this contagion. As the structural and molecular properties of SARS-CoV-2 were being revealed during the early stage of the COVID-19 pandemic, many manufacturers of COVID-19 diagnostic kits actively invested in the design, development, validation, verification, and implementation of diagnostic tests. Currently, diagnostic tests for SARS-CoV-2 are the most widely used and validated techniques for rapid antigen, and immuno-serological assays for specific IgG and IgM antibody tests and molecular diagnostic tests. Molecular diagnostic assays are the gold standard for direct detection of viral RNA in individuals suspected to be infected with SARS-CoV-2. Antibody-based serological tests are indirect tests applied to determine COVID-19 prevalence in the community and identify individuals who have obtained immunity. In the future, it is necessary to explore technical problems encountered in the early stages of global or regional outbreaks of pandemics and provide future directions for better diagnostic tests. This article evaluates the commercially available and FDA-approved molecular and immunological diagnostic assays and analyzes their performance characteristics.

Fabrication of complete denture using digital technology in patient with mandibular deviation: a case report (하악 편위 환자에서 디지털 방식을 이용한 총의치 제작 증례)

  • Lee, Eunsu;Park, Juyoung;Park, Chan;Yun, Kwi-Dug;Lim, Hyun-Pil;Park, Sangwon
    • Journal of Dental Rehabilitation and Applied Science
    • /
    • v.38 no.1
    • /
    • pp.34-41
    • /
    • 2022
  • Recently, digital technology and computer-aided design/computer-aided manufacturing (CAD/CAM) environment have changed the clinician treatment method in the fabrication of dentures. The denture manufacturing method with CAD/CAM technology simplifies the treatment and laboratory process to reduce the occurrence of errors and provides clinical efficiency and convenience. In this case, complete dentures were fabricated using stereolithography (SLA)-based 3D printing in patient with mandibular deviation. Recording base were produced in a digital model obtained with an intraoral scanner, and after recording a jaw relation in the occlusal rim, a definitive impression was obtained with polyvinyl siloxane impression material. In addition, facial scan data with occlusal rim was obtained so that it can be used as a reference in determination of the occlusal plane and in arrangement of artificial teeth during laboratory work. Artificial teeth were arranged through a CAD program, and a gingival festooning was performed. The definitive dentures were printed by SLA-based 3D printer using a Food and Drug Administration (FDA)-approved liquid photocurable resin. The denture showed adequate retention, support and stability, and results were satisfied functionally and aesthetically.

Protective Effect of Niclosamide on Lipopolysaccharide-induced Sepsis in Mice by Modulating STAT3 Pathway (니클로사마이드를 이용한 STAT3 신호전달 조절을 통해 LPS로 유발된 패혈증 동물모델 보호 효과 검증 연구)

  • Se Gwang JANG
    • Korean Journal of Clinical Laboratory Science
    • /
    • v.55 no.4
    • /
    • pp.306-313
    • /
    • 2023
  • Sepsis is a systemic inflammatory response, with manifestations in multiple organs by pathogenic infection. Currently, there are no promising therapeutic strategies. Signal transducer and activator of transcription 3 (STAT3) is a cell signaling transcription factor. Niclosamide is an anti-helminthic drug approved by the Food and Drug Administration (FDA) as a potential STAT3 inhibitor. C57BL/6 mice were treated with an intraperitoneal injection of lipopolysaccharide (LPS). Niclosamide was administered orally 2 hours after the LPS injection. This study found that Niclosamide improved the survival and lung injury of LPS-induced mice. Niclosamide decreased the levels of interleukin-6 (IL-6), tumor necrosis factor-α (TNF-α), and interleukin-1β (IL-1β), aspartate aminotransferase (AST), alanine aminotransferase (ALT), and lactate dehydrogenase (LDH) in serum. The effects of Niclosamide on phosphoinositide 3-kinase (PI3K), AKT, nuclear factor-κB (NF-κB), and STAT3 signaling pathways were determined in the lung tissue by immunoblot analysis. Niclosamide reduced phosphorylation of PI3K, AKT, NF-κB, and STAT3 significantly. Furthermore, it reduced the phosphorylation of STAT3 by LPS stimulation in RAW 264.7 macrophages. Niclosamide also reduced the LPS-stimulated expression of proinflammatory mediators, including IL-6, TNF-α, and IL-1β. Niclosamide provides a new therapeutic strategy for murine sepsis models by suppressing the inflammatory response through STAT3 inhibition.

Synergistic Inhibition of Burkitt's Lymphoma with Combined Ibrutinib and Lapatinib Treatment (Ibrutinib과 Lapatinib 병용 치료에 의한 버킷림프종의 상호 작용적 억제)

  • Chae-Eun YANG;Se Been KIM;Yurim JEONG;Jung-Yeon LIM
    • Korean Journal of Clinical Laboratory Science
    • /
    • v.55 no.4
    • /
    • pp.298-305
    • /
    • 2023
  • Burkitt's lymphoma is a distinct subtype of non-Hodgkin's lymphoma originating from B-cells that is notorious for its aggressive growth and association with immune system impairments, potentially resulting in rapid and fatal outcomes if not addressed promptly. Optimizing the use of Food and Drug Administration-approved medications, such as combining known safe drugs, can lead to time and cost savings. This method holds promise in accelerating the progress of novel treatments, ultimately facilitating swifter access for patients. This study explores the potential of a dual-targeted therapeutic strategy, combining the bruton tyrosine kinase-targeting drug Ibrutinib and the epidermal growth factor receptor/human epidermal growth factor receptor-2-targeting drug Lapatinib. Ramos and Daudi cell lines, well-established models of Burkitt's lymphoma, were used to examine the impact of this combination therapy. The combination of Ibrutinib and Lapatinib inhibited cell proliferation more than using each drug individually. A combination treatment induced apoptosis and caused cell cycle arrest at the S and G2/M phases. This approach is multifaceted in its benefits. It enhances the efficiency of the drug development timeline and maximizes the utility of currently available resources, ensuring a more streamlined and resource-effective research process.