• Title/Summary/Keyword: Drug monitoring

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A Study on HVAC Parameter Monitoring System (Regarding Computer Validation) (HVAC 파라미터 모니터링 시스템에 대한 고찰 (Computer Validation 중심으로))

  • Kim, Jong-Gu
    • Proceedings of the SAREK Conference
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    • 2008.06a
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    • pp.90-95
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    • 2008
  • This article presents practical advice regarding the implementation and management of an impeccable Building Management System. The BMS was introduced to the series of computerized systems including manufacturing, storage, distribution, and quality control. Recently revised GMP regulation is requesting an improvement in drug product quality regulatory system by computer system validation. Quality is critical to guarantee the efficacy and the safety of drugs and is approved in the evaluation process after the audit trail application. HVAC parameter monitoring system will record the identity of operators entering or confirming critical data. Authority to amend entered data should be restricted to nominated persons. Any alteration to an entry of critical data should be authorized in advance and recorded with the reason for the change.

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Recent Trends of Sedation in Pediatric Dentistry (임상가를 위한 특집 3 - 소아치과에서 진정치료의 신경향)

  • Lee, Gi-Seop
    • The Journal of the Korean dental association
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    • v.47 no.11
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    • pp.736-749
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    • 2009
  • 근래 환자의 불안을 조절하는 것이 성공적인 치료에 매우 중요하다는 인식이 확산되면서 의과, 치과, 영상의학과, 응급실 및 외래 수술센터 등에서 진정요법에 대한 필요가 현저하게 늘어났다. 응급상황이거나 아니거나 진정요법의 필요성은 점차 증가하고 있고 대한 소아치과학회는 이러한 진정요법에 대한 지침을 출간한 바 있다. 이번 개정은 진정요법에 필요한 적절한 환자감시(monitoring)의 필요에 관한 최신지견을 반영한 것이나 그럼에도 불구하고 이 지침에 충실하였다고 해서 특정환자의 결과를 보장하지는 못한다. 그러 나 이번에 소개하는 진정요법 protocol은 널리 받아들여지는 것으로 부작용 역시 최소화한 것이다. 소아 환자의 진정요법은 원하는 수준의 진정이나 투여 방법과는 상관없이 호흡기능 저하와 환자의 방어 반응이 소실될 수도 있다는 인식하에 작성되었다. 이번 호에서는 최근 2006년에 미국소아과학회와 미국소아치과학회가 공동으로 개정된 지침(Guideline for Monitoring and Management of Pediatric Patients During and After Sedation for Diagnostic and Therapeutic Procedures developed and endorsed by AAP a and AAPD)이 어떻게 변경되는지에 중점적으로 알아보며 새로 변경된 지침에 따라 소아치과의의 진정요 법의 진료와 교육도 영향을 미칠 것이다. 이러한 영향으로 다양한 약 투여방법(Alternative routes of d drug administration)과 다양한 약물의 선택에 대해 알아 보기로 한다.

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Current Status of Clozapine for Treatment-Resistant Schizophrenia (치료저항성 조현병에서 클로자핀 치료의 현황)

  • Kim, Se Hyun
    • Korean Journal of Schizophrenia Research
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    • v.24 no.1
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    • pp.1-7
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    • 2021
  • Clozapine is the first and most effective atypical antipsychotic drug for treatment-resistant schizophrenia (TRS). After withdrawal of clozapine due to concerns of agranulocytosis, clozapine was reintroduced with a comprehensive safety monitoring system, the clozapine patient monitoring system (CPMS). The reintroduction was a response to the pressure from psychiatrists and patients with TRS and their families. Clozapine is still the best single agent for the treatment of TRS. However, approximately 30% of patients with TRS still show psychotic symptoms. In patients with clozapine-resistant schizophrenia (CRS), augmentation of other antipsychotic agents could be considered after a thorough evaluation of proper clozapine treatment. In this review, the status of clozapine in patients with TRS and CRS will be discussed.

Monitoring of Lead and Cadmium Contents of Vegetables in Korea (국내 유통 중인 채소류의 납, 카드뮴 함량 모니터링)

  • Shim, Jee-Youn;Oh, Hyun-Suk;Jang, Mi-Ran;Lee, Yoon-Ae;Lee, Ryun-Kyung;Kim, Min-A;Lee, Hyo-Jung;Lee, Sang-Min;Cho, Tae-Youg
    • Journal of Food Hygiene and Safety
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    • v.25 no.4
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    • pp.395-401
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    • 2010
  • This research was carried out as a survey on the contents of Lead (Pb) and Cadmium (Cd) in 5 type agricultural products unestablished safety guideline in Korea. The average levels of Pb: onion 0.010 mg/kg, cucumber 0.018 mg/kg, garlic 0.012 mg/kg, green pepper 0.027 mg/kg, sesame 0.029 mg/kg. The average levels of Cd: onion 0.006 mg/kg, cucumber 0.002 mg/kg, garlic 0.008 mg/kg, green pepper 0.011 mg/kg, sesame 0.024 mg/kg. The present result of this study showed that Pb and Cd contents in the whole samples were less than the maximum residual levels of the codex standard. The levels of exposure assessment for Pb and Cd by intake from vegetables and sesame were merely at $1.3{\times}10^{-4}$(mean) ~ $5.1{\times}10^{-4}$($95^{th}$ percentiles) ${\mu}$g/kg bw/day for Pb, $7.5{\times}10^{-5}$(mean) ~ $3.6{\times}10^{-4}$($95^{th}$ percentiles) ${\mu$}g/kg bw/day for Cd. The data from this research will be valuable source for database construction for science-based safety control and management for the trace metal contamination in food including agricultural products.

A Study on Residual Amounts of Vinyl Chloride/Vinylidene Chloride in Poly(vinyl chloride)/Poly(vinylidene chloride) Food Packaging using Headspace GC/MS (헤드스페이스 GC/MS를 이용한 폴리염화비닐/폴리염화비닐리덴 식품 포장 중 염화비닐/염화비닐리덴 잔류량 연구)

  • Sung, Jun-Hyun;Kwak, In-Shin;Park, Sung-Kwan;Kim, Hyung-Il;Lim, Ho-Soo;Lee, Ju-Young;Byun, Mi-Yun;Kim, So-Hee
    • Korean Journal of Food Science and Technology
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    • v.43 no.1
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    • pp.6-11
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    • 2011
  • Vinyl chloride (VC) and vinylidene chloride (VDC), which may be present in poly(vinyl chloride) (PVC) and poly(vinylidene chloride) (PVDC) food packaging, were analyzed by using a headspace-gas chromatograph (GC)/mass spectrometer (MS) equipped with a PLOT Q column. 1-Chloropropane (1-CP) was used as an internal standard. The determinations of VC and VDC were carried out by monitoring the characteristic ions for each compound: m/z=61, 62, 64 and m/z=61, 96, 98, respectively. The method validated in this study can be suitable for the compliance test of EU regulation. Among 103 food packaging samples, VC and VDC were not detected, except in one PVDC food package. However, the detected level of VDC in the sample was below the EU regulatory specific limitation.

Investigation of Pathogenic Microorganism from Saengsik-classes (시판생식의 위해미생물 오염도 조사)

  • Cho, Joon-Il;Park, Yong-Chjun;Ko, Soo-Il;Cheung, Chi-Yeun;Lee, Sun-Mi;Cho, Soo-Yeol;Lee, Kwang-Ho;Lim, Chul-Joo;Kim, Ok-Hee
    • Journal of Food Hygiene and Safety
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    • v.23 no.3
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    • pp.257-263
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    • 2008
  • As Standards and Specifications of the Saengsik-classes has been established since 2005 by KFDA. The microbial Standards and Specifications of the Saengsik-classes is as follows; no detection in Escherichia coli, colony forming unit less then 1,000/g in Bacillus cereus, colony forming unit less then 100/g in Clostridium perfringens respectively. Contamination levels of Total aerobic bacteria, Escherichia coli, Bacillus cereus and Clostridium perfringens in Saengsik-classes were monitored. Total aerobic bacteria counts in Saengsik-classes was $1{\times}10^1{\sim}5.3{\times}10^7cfu/g$, for Bacillus cereus $1{\times}10^2{\sim}9{\times}10^2cfu/g$, for Clostridium perfringens $1{\times}10^1cfu/g$. Escherichia coli, was not isolated from all Saengsik-classes. Thess results will provide information for introduction of HACCP system to ensure microbial safety of Saengsik-classes.

Development of Analytical Method for Determination of Baicalin, Eleutheroside E, and Ligustilide by LC-MS/MS in Raw Materials of Health Functional Foods (LC-MS/MS를 이용한 건강기능식품 원료 중 바이칼린, 엘레우테로사이드 E, 리구스틸라이드 동시분석법 개발)

  • Keum, Eun Hee;Chung, So Young;Lee, Jin Hee;Kim, Meehye
    • Journal of Food Hygiene and Safety
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    • v.32 no.3
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    • pp.193-198
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    • 2017
  • Scutellaria baicalensis, Eleutherococcus senticosus, and Angelica sinensis have been used as raw materials for health functional foods. This study was conducted to develop a novel method to analyze levels of baicalin (Scutellaria baicalensis), eleutheroside E (Eleutherococcus senticosus), and ligustilide (Angelica sinensis) simultaneously in health functional foods. The methanol extracted samples were analyzed and quantified via liquid chromatography-tandem mass spectrometry (LC-MS/MS) in the positive ion mode and the negative ion mode using multiple reaction monitoring. Standard calibration curves confirmed linearity with the correlation coefficient ($r^2$) of > 0.99 at $100-2000{\mu}g/mL$ concentration range. The limits of detection (LODs) and limits of quantitation (LOQs) were in the range of $13.0{\sim}35.2{\mu}g/L$ and $39.3{\sim}106.7{\mu}g/L$, respectively. The recovery results ranged between 91.4~109.9% at 3 different concentration levels with relative standard deviations (RSDs) less than 5%. The proposed analytical method was characterized with high accuracy and acceptable precision. The new method would be an effective tool to analyze baicalin, eleutheroside E, and ligustilide simultaneously in raw materials of health functional foods.

Analysis of Flumeqnine in Meats (식육 중 항생제 flumequine의 분석)

  • Kuk, Ju-Hee;Ko, Yong-Seok;Kim, Yong-Hoon;Yoon, Chang-Yong;Sun, Nam-Kyu;Kim, Eun-Jung;Seo, Jee-Woo;Park, Ji-Won;Kang, Kil-Jin
    • Korean Journal of Food Science and Technology
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    • v.41 no.1
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    • pp.7-10
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    • 2009
  • An analytical method for the determination of flumequine in meats was developed and validated using high-performance liquid chromatography with fluorescence detection. The samples were mixed with sodium sulfate and extracted with ethyl acetate. After clean-up, the residues were dissolved in mobile phase. The calibration curves showed high linearity ($r^2$=0.9979) within the concentration range of 0.1-1.0 mg/kg. The limit of detection and limit of quantification were validated at 0.005 and 0.017 mg/kg, respectively. The recoveries in fortified meats ranged from 90.8 to 101.1%. The method was then validated in correspondence with the CODEX guidelines for flumequine residue in meats. Herein we monitored 150 samples of meats that were purchased in Korea (Seoul, Busan, Daegu, Daejeon, and Gwangju). Among the tested samples, flumequine was detected in 1 of beef and 1 of pork at levels in the range of 0.048-0.080 mg/kg. Overall, the flumequine residues in the tested samples were within the Maximun residue limit.

바이오 센서 및 랩온어칩

  • 박유근
    • The Magazine of the IEIE
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    • v.31 no.1
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    • pp.58-72
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    • 2004
  • Smart sensors and biochip technologies have received a great deal of attention in recent years not only because of the enormous potential markets in the healthcare expenditures but more importantly because of its great impact on the quality of human life in the future. Collaborative research among BT (Bio Technologies), IT (Information Technologies) and NT (Nano Technologies) will bring us a new paradigm of the healthcare services. Examples include disease prediction based on the genetic tests, personal medicines, point-of-care analysis, rapid and sensitive infectious disease diagnostics, environmental monitoring for chemical or biological warfares, intelligent drug delivery systems etc. In this report, recent accomplishment in the research area on biosensors, DNA chips, Protein Chips and Lab-on-a-chips are reviewed.

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마이크로머시닝 기술의 의학 및 생물학 응용

  • 장준근;김용권
    • The Magazine of the IEIE
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    • v.24 no.10
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    • pp.63-72
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    • 1997
  • Application of MEMS to biologic system mainly categorized into bio-electronics and micro-medical systems, Bio-electronics concerns on the biocompatible electronic device, in-vivo sensors, the sensors based on biological materials, biological materials for electronics and optics, the concepts and materials Inspired by biology and useful for electronics, the algorithm inspired by biology, artificial sense, and the biologic-inorganic hybrids. Micro-medical systems are utilited into the drug delivery systems, micro patient monitoring systems, micro prosthesis and artificial organs, cardiology related prothesis, analysis systems, and the minimal invasive surgery tools based on the m icrom achining technology.

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