• Title/Summary/Keyword: Approved

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Recommendation for the use of newly introduced Tdap vaccine in Korea

  • Choi, Kyong-Min;Kim, Kyung-Hyo;Kim, Yae-Jean;Kim, Jong-Hyun;Park, Su-Eun;Lee, Hoan-Jong;Eun, Byung-Wook;Jo, Dae-Sun;Choi, Eun-Hwa;Hong, Young-Jin
    • Clinical and Experimental Pediatrics
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    • v.54 no.4
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    • pp.141-145
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    • 2011
  • Pertussis is an acute respiratory infection characterized by paroxysmal cough and inspiratory whoop for over 2 weeks. The incidence of pertussis has decreased markedly after the introduction of DTwP/DTaP vaccine, but the incidence of pertussis has increased steadily among young infant and among adolescents and adults in many countries. Td vaccine was used in this age group but the increase in pertussis has lead to the development of a Tdap vaccine. The Tdap vaccine is a Td vaccine with a pertussis vaccine added and is thought to decrease the incidence and transmission of pertussis in the respective age group. In Korea, two products are approved by the KOREA FOOD & DRUG ADMINISTRATION, which are ADACEL$^{TM}$ (Sanofi-Pasteur, Totonto, Ontario, Canada) and BOOSTRIX$^{(R)}$ (GlaxoSmithKline Biologicals, Rixensart, Belgium) for those aged between 11-64. This report summarizes the recommendations approved by the Committee on Infectious Diseases, the Korean Pediatric Society.

Evaluation of the Bacteriological Safety for the Shellfish Growing Area in Jaranman.Satyangdo Area, Korea (자란만.사량도 패류생산해역의 위생학적 안전성 평가)

  • Shim, Kil-Bo;Ha, Kwang-Soo;Yoo, Hyun-Duk;Kim, Ji-Hoe;Lee, Tae-Seek
    • Korean Journal of Fisheries and Aquatic Sciences
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    • v.42 no.5
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    • pp.442-448
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    • 2009
  • Bacteriological examination of a 12,700 ha area within Jaranman Saryangdo area, located in Jaran bay and Saryangdo island, was conducted with 35 fixed (designated areas and adjacent areas) seawater sampling stations between January 2006 and December 2008. According to results, the geometric mean range and the estimated 90th percentile range of fecal coliform counts in sea water samples collected in the designated area were <1.8-2.4 and <1.8-8.6 MPN/100mL, respectively. The estimated 90th percentile range of fecal coliform counts in sea water samples collected from 6 sampling stations in the adjacent areas were 6.1-34.6 MPN/100mL. Based on these results, bacteriological water quality of the designated areas in the Jaranman. Saryangdo area meet the NSSP (National Shellfish Sanitation Program) guidelines for approved area. The bacteriological sea water quality in Jaranman.Saryangdo area has been shown to be favorable at all investigated sampling stations except for July and August which coincided with heavy rainfall. In fact, the bacteriological water quality was not affected if rainfall was less than 30 mm rainfall. However, the degree of bacteriological contamination increased rapidly and the water quality exceeded approved NSSP guidelines set for rainfall above 60 mm.

Chemical Genomics with Natural Products

  • Jung, Hye-Jin;Ho, Jeong-Kwon
    • Journal of Microbiology and Biotechnology
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    • v.16 no.5
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    • pp.651-660
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    • 2006
  • Natural products are a rich source of biologically active small molecules and a fertile area for lead discovery of new drugs [10, 52]. For instance, 5% of the 1,031 new chemical entities approved as drugs by the US Food and Drug Administration (FDA) were natural products between 1981 and 2002, and another 23% were natural product-derived molecules [53]. These molecules have evolved through millions of years of natural selection to interact with biomolecules in the cells or organisms and offer unrivaled chemical and structural diversity [14, 37]. Nonetheless, a large percentage of nature remains unexplored, in particular, in the marine and microbial environments. Therefore, natural products are still major valuable sources of innovative therapeutic agents for human diseases. However, even when a natural product is found to exhibit biological activity, the cellular target and mode of action of the compound are mostly mysterious. This is also true of many natural products that are currently under clinical trials or have already been approved as clinical drugs [11]. The lack of information on a definitive cellular target for a biologically active natural product prevents the rational design and development of more potent therapeutics. Therefore, there is a great need for new techniques to expedite the rapid identification and validation of cellular targets for biologically active natural products. Chemical genomics is a new integrated research engine toward functional studies of genome and drug discovery [40, 69]. The identification and validation of cellular receptors of biologically active small molecules is one of the key goals of the discipline. This eventually facilitates subsequent rational drug design, and provides valuable information on the receptors in cellular processes. Indeed, several biologically crucial proteins have already been identified as targets for natural products using chemical genomics approach (Table 1). Herein, the representative case studies of chemical genomics using natural products derived from microbes, marine sources, and plants will be introduced.

Chromogenic In Situ Hybridisation Test for Breast Cancer Patients with Equivocal IHC Results - a Study from Iran

  • Mehrazma, Mitra;Kalantari, Elham;Rezvani, Hamid;Bahar, Babak;Basi, Ali;Razavi, Seyed Mohsen;Rakhshani, Nasser
    • Asian Pacific Journal of Cancer Prevention
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    • v.16 no.17
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    • pp.7695-7700
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    • 2015
  • Background: HER2/neu overexpression on cell membranes of breast cancer cells is due to HER2/neu gene amplification and it is important to identify potential candidates for anti HER2 therapy with trastuzumab. IHC, FISH and CISH are standard FDA approved assays currently used to determine HER2 status in routine practice. The aim of this study was to determine HER2 gene amplification, using the CISH method in breast carcinoma samples which had IHC +2 reactions. Materials and Methods: This study was conducted from 2008-2010 using 334 consecutive breast carcinoma samples referred from local laboratories to Mehr Hospital. CISH assays were performed for all cases, and IHC tests were also done for determining efficacy and accuracy of local labs. HER2 status in local IHC tests was compared with central IHC and CISH results. Results: Of 334 breast cancer patients, 16 were negative for HER2 IHC (0, +1), 201 cases were equivocal (+2), and 31 positive (+3). Of 334 referral cases, 88 were CISH positive (26.3%) and 246 were CISH negative (73.7%). Of 201 IHC +2 cases, HER2 gene amplification was observed in 42 cases (kappa: 0.42). A 29.9% concordance was found between local IHC and central IHC. Sensitivity and specificity of local IHC were 90% and 53.8%, respectively. Conclusions: Low accuracy of IHC results in local labs was associated with the following factors: using former FDA-approved criteria for HER2 interpretation, utilizing non-validated kits, and lack of any quality assurance program. Therefore, following the new 2014 ASCO/CAP guideline and comprehensive quality assurance should be implemented to ensure accuracy of HER2 testing.

Updates to Clinical Information on Anticancer Immunotherapy (항암 면역 치료제에 관한 최근 임상 정보)

  • Choi, Eunjoo;Yang, Jae Wook
    • Korean Journal of Clinical Pharmacy
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    • v.28 no.1
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    • pp.65-75
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    • 2018
  • Objective: Over the last several years, immunotherapy has become one of the most promising therapeutic options for cancer. This study aims to summarize the updates on cancer immunotherapy focusing on immune checkpoint inhibitors, such as programmed cell death-1 (PD-1), programmed death-ligand 1 (PD-L1), and cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) inhibitors, which have received attention as new anticancer therapeutic agents. Methods: A literature survey was carried out on PubMed to identify high-impact papers on cancer immunotherapy from 2010. The most recent data on clinical efficacy and safety have been included highlighting the response characteristics to recently approved immunotherapeutic agents. Results: In various cancers, immune checkpoints are a means for cancer cells to evade the immune system. Furthermore, CTLA-4 and PD-L1 can be overexpressed, allowing malignant cells to evade T-cells. Numerous clinical trials have been performed to seek appropriate indication of these products in various cancer types. Among them, the most conspicuous types are melanoma, non-small-cell lung cancer, and head and neck cancer. The approval of ipilimumab by Food and Drug Administration (FDA) commenced a new era of cancer immunotherapy. This was followed by the approval of nivolumab and pembrolizumab. Currently, combination therapies are being investigated for various cancer types. Conclusion: In this study, we reviewed recently reported scientific and clinical evidence for currently approved immune checkpoint inhibitors. Although these novel checkpoint inhibitors are ever evolving for cancer therapies, there exist limitations that need to be overcome, indicating the necessity for further studies aiming to improve their efficacy, toxicity, and cost.

Evaluation of the Bacteriological Safety of the Shellfish-growing Area in Gangjinman, Korea (강진만 패류생산해역의 위생학적 안전성 평가연구)

  • Park, Kun-Ba-Wui;Jo, Mi-Ra;Kwon, Ji-Young;Son, Kwang-Tea;Lee, Doo-Seog;Lee, Hee-Jung
    • Korean Journal of Fisheries and Aquatic Sciences
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    • v.43 no.6
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    • pp.614-622
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    • 2010
  • The sanitary quality of a shellfish-growing area in Gangjinman, Korea, was assessed through a bacteriological examination of seawater form January 2007 to December 2009. The range of the geometric mean (GM) and the estimated 90th percentile for most-probable-number (MPN) values for fecal coliforms in samples collected in the designated area were 2.0-2.4 and 6.1-11.5 MPN/100 mL, respectively. Therefore, the bacteriological quality of seawater in the designated area in the Gangjinman area met the National Shellfish Sanitation Program (NSSP, USA) guidelines for approved areas. Also, the sanitary status of shellfish harvested from the designated area met the Korean Shellfish Sanitation Program (KSSP) fecal coliform criterion (<230 MPN/100 g). However, the degree of bacteriological contamination increased rapidly, and water quality exceeded the criteria for approved areas when large amounts of rain fell before the sampling date. Fortunately, fecal pollutants did not affect the bacteriological quality of a buffer zone established between the shoreline and the designated area. These results indicate that the current buffer zone established around the designated area protects the designated area properly.

Operation Fee and Insurance Charge of Hallux Valgus Surgery (무지 외반증의 수술비 및 보험)

  • Song, Ha-Heon;Shim, Dae-Moo;Kim, Dong-Churl;Kweon, Seok-Hyun;Kim, Jong-Yun
    • Journal of Korean Foot and Ankle Society
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    • v.10 no.2
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    • pp.238-241
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    • 2006
  • Purpose: The purpose of this study was to figure out the appropriate and systemic insurance charge for the hallux valgus operations. Materials and Methods: 5 Hospitals for hallux valgus operations were analyzed how they have been charging the national health insurance corporation for their operation fees and how to use the estimated guide and authoritive interpretation through the guide book of health insurance medical treatment grant expense and the guide book of Health insurance medical treatment. Results: There are nothing for guiding principle of hallux valgus operations in both books but a guide of Mcbride operation which is approved 'JA-93-KA and JA-31' for operation fee. So majority of hospitals have charged operation fee depending on their own interpretations they like. According to the guide books, there was a authoritive interpretation that simultaneous operation of osteotomy and tendon transfer for cerebral palsy and flat foot can be eatimated as 'osteotomy+JA-93-NA'. Conclusion: Distal soft tissue procedure should be approved as 'JA-93-NAx100%+JA-31x50%' according to the the estimated guide and authoritive interpretation if transected adductor hllucis is transfered to first metatarsal head. So distal chevron osteotomy could be 'JA-30-1-RAx100%+JA-31x50%', proximal metatarsal osteotomy could be 'JA- 93-NAx100%+JA-31-50%+JA-30-1-RAx50%', first metatarsocuneiform joint arthrodesis could be 'JA-93-NAx100%+ JA-31x50%+JA-73-RAx50%'.

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Radiation safety management for diagnostic radiation generators and employees in animal hospitals in Korea (동물병원의 진단용 방사선 발생장치 및 방사선종사자 안전관리 실태 조사)

  • An, Hyo-Jin;Kim, Chung-Hyun;Kwon, Young-Jin;Kim, Don-Hwan;Wee, Sung-Hwan;Moon, Jin-San
    • Korean Journal of Veterinary Research
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    • v.54 no.3
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    • pp.151-157
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    • 2014
  • A nationwide survey on radiation safety management in Korean animal hospitals was conducted. By 2013, 53 radiation generators were registered as veterinary medical devices (41 X-ray generators and 12 computed tomography scanners). Additionally there were six approved laboratories for radiation equipment and protection facility, and five approved laboratories for radiation exposure of employees, respectively. By March 2013, 2,030 out of 3,829 animal hospitals operated radiation-generating devices. Among these devices, 389 (19.2%) out of 2,030 were not labeled with the model name and 746 (36.7%) were not labeled with production dates. Thus, most veterinary X-ray generators were outdated (42.6%) and needed replacements. When periodic inspections of 2,018 animal hospitals were performed after revision of the Veterinarians Act in 2011, the hospitals were found to be equipped with appropriate radiation generators and protection facilities. Among 2,545 employees exposed to radiation at the hospitals, 93.9% were veterinarians, 4.3% were animal nurse technicians, and 18% held other positions. Among 169 employees supervised by administrators, none of those had a weekly maximum operating load that exceeded $10mA{\cdot}min$. This study suggests that the radiation safety management system of animal hospitals was general good.

Evaluation of Suitability of Non-Standardized Test Block for Ultrasonic Testing (비규격 초음파 탐상용 표준시험편의 사용안전성 평가)

  • Kwon, Ho-Young;Lim, Jong-Ho;Kang, Sei-Sun
    • Journal of the Korean Society for Nondestructive Testing
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    • v.20 no.5
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    • pp.431-437
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    • 2000
  • Standard Test Block(STB) for UT(Ultrasonic Testing) is a block approved by authoritative for material, shape and quality. STB is used for characteristic tests, sensitivity calibration and control of the time base range of UT inspection devices. The material, size and chemical components of STB should be strictly controled to meet the related standards such as ASTM and JIS because it has an effect upon sensitivity, resolution and reproductivity of UT. The STBs which are not approved are sometimes used because the qualified STBs are very expensive. So, the purpose of this study is to survey the characteristics, quality and usability of Non-Standardized Test Blocks. Non-Standardized Test Blocks did not meet the standard requirements in size or chemical components, and ultrasonic characteristics. Therefore if the Non-Standardized Test Blocks are used without being tested, it's likely to cause errors in detecting the location and measuring the size of the defects.

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Detection of Genetically Modified Maize Safety-approved in Korea Using PCR (PCR을 이용한 국내에서 안전성이 확인된 유전자재조합 옥수수의 분석 방법)

  • Heo, Mun-Seok;Kim, Jae-Hwan;Park, Sun-Hee;Woo, Geon-Jo;Kim, Hae-Yeong
    • Korean Journal of Food Science and Technology
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    • v.35 no.6
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    • pp.1033-1038
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    • 2003
  • Four lines (MON810, GA21, NK603, and TC1507)of genetically modified maize(GMM) were recently approved after a safety-assessment by the Korea Food and Drug Administration (KFDA). In this study, five pairs of specific oligonucleotide primers, based on the gene sequences inserted into maize and zein gene as internal standards, were designed and a method using PCR was developed for monitoring GMM and GMM derived foods circulating in the market. MON810 and GA21 were detected in raw materials of feed and food in the Korean market.