• Title/Summary/Keyword: Precision medicine (PM)

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Identification of Standard Compound of Ja-ha-guh Pharmacopuncture and Validation of Analytic Methods (자하거 약침의 지표물질 선정 및 분석법 벨리데이션)

  • Park, Sang-won;Lee, Jae-woong;Lee, Jin-ho;Ha, In-Hyuk;Byun, Jang-hoon;Jung, Bum-hwan;Jung, Hwa-jin;Lee, In-hee;Kim, Min-Jeong;Kim, Eun-Jee
    • Journal of Korean Medicine Rehabilitation
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    • v.26 no.1
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    • pp.33-40
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    • 2016
  • Objectives Despite the increasing use of Ja-ha-guh (Hominis-placenta ) pharmacopuncture in rehabilitative medicine field, its standard compound has yet to be investigated. The purpose of this study is to provide standardization for future studies and increase satisfaction of patients by utilizing standard pharmacopuncture. Methods Alanine and leucine were selected as potential standard compounds. LC/MS was used to devise an analytic method. This analytic method was subject to validation. According to validation guideline of Korea Food and Drug Administration, the specificity, linearity, precision, range, quantitative limits, detection limits and accuracy were measured. With this analysis, 3 lots of Ja-ha-guh pharmacopuncture were analyzed. Results Because the specificity, linearity, precision, range, quantitative limits, detection limits and accuracy meet criteria of the guideline, the analytic method was validated. It was found that Ja-ha-guh pharmacopuncture contained $211.02{\pm}7.28ug/ml$ of alanine and $372.03{\pm}7.58ug/ml$ of leucine. Conclusions Both alanine and leucine appear to be suitable standard compounds. These results are likely to contribute to further standardization of Ja-ha-guh for medical use.

THREE-DIMENSIONAL VERIFICATION OF INTRACRANIAL TARGET POINT DEVIATION USING MRI-BASED POLYMER-GEL DOSIMETRY FOR CONVENTIONAL AND FRACTIONATED STEREOTACTIC RADIOSURGERY

  • Lee, Kyung-Nam;Lee, Dong-Joon;Suh, Tae-Suk
    • Journal of Radiation Protection and Research
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    • v.36 no.3
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    • pp.107-118
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    • 2011
  • Conventional (SRS) and fractionated (FSRS) stereotactic radiosurgery necessarily require stringent overall target point accuracy and precision. We determine three-dimensional intracranial target point deviations (TPDs) in a whole treatment procedure using magnetic resonance image (MRI)-based polymer-gel dosimetry, and suggest a technique for overall system tests. TPDs were measured using a custom-made head phantom and gel dosimetry. We calculated TPDs using a treatment planning system. Then, we compared TPDs using mid bi-plane and three-dimensional volume methods with spherical and elliptical targets to determine their inherent analysis errors; finally, we analyzed regional TPDs using the latter method. Average and maximum additive errors for ellipses were 0.62 and 0.69 mm, respectively. Total displacements were 0.92 ${\pm}$ 0.25 and 0.77 ${\pm}$ 0.15 mm for virtual SRS and FSRS, respectively. Average TPDtotal at peripheral regions was greater than that at central regions for both. Overall system accuracy was similar to that reported previously. Our technique could be used as an overall system accuracy test that considers the real radiation field shape.

Quantitative Analysis of Methotrexate using Hitach-7600 P-module (Hitach-7600 P-module을 이용한 Methotrexate 정량분석 평가)

  • Kim, Min-Eui;Cha, Kyong-Ho;Kim, Seung-Hee;Kim, Nam-Joo;Chae, Hyo-Jin
    • Korean Journal of Clinical Laboratory Science
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    • v.41 no.4
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    • pp.167-172
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    • 2009
  • Methotrexate (MTX) in one of the antineoplastic drug and it is known to effective to management of acute lymphoblastic leukemia in children, management of choriocarcinoma and related trophoblastic tumors in women, management of carcinomas of the breast, tongue, pharynx, and tests, maintenance of remission in leukemia and treatment of serve, debilitating psoriasis. Intermediate to high-dose methotrexate administration followed by leucovorin rescue is effective in treatment of carcinoma of the lung and osteogenic sarcoma. Intrathecal administration is effective in treating meningeal leukemia or lymphoma. There are FPIA (Fluorescence polarization immunoassay) and EMIT (Enzyme multiplied immunotechique) methods that measure for MTX. We evaluated the FPIA and EMIT methods. MTX were measured by Hitachi-7600 P-module using EMIT and FPIA using TDX in the sera 60 patients. The performance characteristics evaluated were, light influence, linearity, comparison with FPIA. Also, precision evaluated were three level controls through put following CLSI evaluation protocols (EP10-A). When the MTX value of $4.16{\pm}5.78{\mu}{\mu}mol/L$ (mean, SD) by the Hitachi-7600 P-module was compared with that of $4.05{\pm}5.47{\mu}{\mu}mol/L$ by FPIA, coefficients of correlation of 0.988 was obtained. The regression equation was Y (Hitachi-7600 P-module) = 0.9408 x (FPIA) + 0.1316 (r=0.9885, n=60). CVs of MTX measured by Hitachi 7600 P-module was 6.78% at $0.33{\mu}{\mu}mol/L$, 0.96% at $1.16{\mu}{\mu}mol/L$, and 0.96% at $8.04{\mu}{\mu}mol/L$. The precision was excellent in each group. The linearity was acceptable. We evaluated that MTX is light-sensitive on prolonged exposure to direct sunlight. Comparing with the FPIA using TDX, the Hitachi-7600 P-module using EMIT showed good coefficient of correlation and precision. Therefore the Hitachi-7600 P-module can replace the FPIA for quantitative analysis of MTX.

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Disease Prediction By Learning Clinical Concept Relations (딥러닝 기반 임상 관계 학습을 통한 질병 예측)

  • Jo, Seung-Hyeon;Lee, Kyung-Soon
    • KIPS Transactions on Software and Data Engineering
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    • v.11 no.1
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    • pp.35-40
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    • 2022
  • In this paper, we propose a method of constructing clinical knowledge with clinical concept relations and predicting diseases based on a deep learning model to support clinical decision-making. Clinical terms in UMLS(Unified Medical Language System) and cancer-related medical knowledge are classified into five categories. Medical related documents in Wikipedia are extracted using the classified clinical terms. Clinical concept relations are established by matching the extracted medical related documents with the extracted clinical terms. After deep learning using clinical knowledge, a disease is predicted based on medical terms expressed in a query. Thereafter, medical terms related to the predicted disease are selected as an extended query for clinical document retrieval. To validate our method, we have experimented on TREC Clinical Decision Support (CDS) and TREC Precision Medicine (PM) test collections.

Concentrations of Bioavailable Testosterone and Dihydrotestosterone Determined by Luminescence Immunoassay in Serum (혈청내 섬광면역측정법에 의한 활성적 Testosterone과 Dihydrotestosterone의 농도)

  • Yoon, Yong-Dal;Lee, Chang-Joo;Chun, Eun-Hyun;Lee, Joon-Yeong
    • Clinical and Experimental Reproductive Medicine
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    • v.15 no.2
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    • pp.83-92
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    • 1988
  • 혈액에서 생물학적 활성을 나타내는 (bioavailable) steroid hormone은 주로 비결합형(free form)과 알부민 결합형(albumin-bound form)으로 구성된다. 특히 Testosterone (T)과 5 alpha-Dihydrotestosterone (DHT)의 활성적 분획이 전체의 T, DHT 양에 비해 생리적 현상과 보다 잘 일치하는 것으로 알려지고 있다. 본 연구는 섬광면역측정법(Luminescence immunoassay, LIA)으로 혈청내 활성적 T 및 DHT의 농도의 측정에 이용하고져 하였다. 항체는 T- 또는 DHT-3-CMO-BSA를 항원으로 토끼에 면역주사하여 얻었다. 추적자는 T-3-CMO, DHT-3-CMO에 aminobutylethylisoluminol(ABEI)를 부착시켜 사용하였다. 항체중 IgG분획을 Protein-A-Sepharose CL-4B로 분리한 후 Immunobead(Bio-Rad)에 부착시켜 Solid-phase LIA를 실시하였다. 본 연구에서 LIA는 정확도(accuracy), 정밀도(precision), 감도(sensitivity), 교차반응도(specificity)등을 조사하고, 기존의 방사면역측정법(RIA)과 비교하여 만족할만한 결과를 얻었다. 혈청내 T및 DHT의 활성적 분획의 농도를 측정한 결과는 다음과 같았다. T의 경우는 남성에서 T의 전체량의 33% 이상으로 $7.1{\pm}1.5nmol/l$, 여성에서는 26% 이상으로 $0.28{\pm}0.05nmol/l$이었다. DHT의 활성적 분획은 남성의 경우 $601.7{\pm}85.8pmol/l$, 여성의경우 $52.4{\pm}19.9\;pmol/l$이었다. 이상의 결과를 보아 본 연구에서 이용된 LIA는 혈청내 활성적 농도를 측정하기에 충분하다고 사료된다. 또한 이 방법을 이용하여 여성의 Androgenicity 및 남성 정소기능등의 제어방법에 응용될 수 있을 것으로 판단된다.

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Bioequivalence Study on Two Talniflumate Preparations Commercially Available in Korean (탈리플루메이트 제제에 대한 생물학적동등성 평가)

  • Sohn, Uy-Dong;Jeong, Ji-Hoon;Kim, Kyung-Tae;Cho, Young-Rae;Min, Young-Sil;Song, Hyun-Ju;Je, Hyun-Dong;Yim, Sung-Hyuk;Shin, Yong-Kyoo;Cho, Seong-Wan
    • Korean Journal of Clinical Pharmacy
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    • v.16 no.2
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    • pp.101-106
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    • 2006
  • The aim of the present study was to evaluate the bioequivalence of two talniflumate preparations. We used Somalgen tablet (Kun Wha Pharmaceutical Co., Korea.) as a reference drug for bioequivalence of Crimain tablet (Samjini Pharmaceutical Ind. Co., Korea), and performed this whole study according to the guidelines of Korea Food and Drug Administration (KFDA). Twenty four healthy male volunteers, $22.8{\pm}2.2$ years in age and $64.6{\pm}5.3\;kg$ in body weight, were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After one tablet containing 370 mg of talniflumate was orally administered, blood was taken at predetermined time intervals and the concentrations of talniflumate in plasma were determined using HPLC method with UV-detector. The analysis system was validated in specificity, accuracy, precision and linearity. These items of the analysis condition in this study conform to the guideline of KFDA. The pharmacokinetic parameters such as $AUC_t\;and\;C_{max}$ were calculated using the analysis condition we established and ANOVA test was utilized for the statistical analysis of the parameters using logarithmically transformed $AUC_t$ and Cmax. $Mean{\pm}SD$ of reference drug and test drug in $AUC_t\;and\;C_{max}$ value were $1.27{\pm}0.58\;({\mu}g/ml{\cdot}hr)\;and\;0.27{\pm}0.13\;({\mu}g/ml)$ and $1.14{\pm}0.46\;({\mu}g/ml{\cdot}hr)\;and\;0.26{\pm}0.10\;({\mu}g/ml)$ respectively. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of log(0.8) to log (1.25) for $AUC_t\;and\;C_{max}$, respectively. These results indicate that Samjin talniflumate tablet is bioequivalent to reference drug, Somalgen tablet.

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The Precision Test Based on States of Bone Mineral Density (골밀도 상태에 따른 검사자의 재현성 평가)

  • Yoo, Jae-Sook;Kim, Eun-Hye;Kim, Ho-Seong;Shin, Sang-Ki;Cho, Si-Man
    • The Korean Journal of Nuclear Medicine Technology
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    • v.13 no.1
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    • pp.67-72
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    • 2009
  • Purpose: ISCD (International Society for Clinical Densitometry) requests that users perform mandatory Precision test to raise their quality even though there is no recommendation about patient selection for the test. Thus, we investigated the effect on precision test by measuring reproducibility of 3 bone density groups (normal, osteopenia, osteoporosis). Materials and Methods: 4 users performed precision test with 420 patients (age: $57.8{\pm}9.02$) for BMD in Asan Medical Center (JAN-2008 ~ JUN-2008). In first group (A), 4 users selected 30 patient respectively regardless of bone density condition and measured 2 part (L-spine, femur) in twice. In second group (B), 4 users measured bone density of 10 patients respectively in the same manner of first group (A) users but dividing patient into 3 stages (normal, osteopenia, osteoporosis). In third group (C), 2 users measured 30 patients respectively in the same manner of first group (A) users considering bone density condition. We used GE Lunar Prodigy Advance (Encore. V11.4) and analyzed the result by comparing %CV to LSC using precision tool from ISCD. Check back was done using SPSS. Results: In group A, the %CV calculated by 4 users (a, b, c, d) were 1.16, 1.01, 1.19, 0.65 g/$cm^2$ in L-spine and 0.69, 0.58, 0.97, 0.47 g/$cm^2$ in femur. In group B, the %CV calculated by 4 users (a, b, c, d) were 1.01, 1.19, 0.83, 1.37 g/$cm^2$ in L-spine and 1.03, 0.54, 0.69, 0.58 g/$cm^2$ in femur. When comparing results (group A, B), we found no considerable differences. In group C, the user_1's %CV of normal, osteopenia and osteoporosis were 1.26, 0.94, 0.94 g/$cm^2$ in L-spine and 0.94, 0.79, 1.01 g/$cm^2$ in femur. And the user_2's %CV were 0.97, 0.83, 0.72 g/$cm^2$ L-spine and 0.65, 0.65, 1.05 g/$cm^2$ in femur. When analyzing the result, we figured out that the difference of reproducibility was almost not found but the differences of two users' several result values have effect on total reproducibility. Conclusions: Precision test is a important factor of bone density follow up. When Machine and user's reproducibility is getting better, it’s useful in clinics because of low range of deviation. Users have to check machine's reproducibility before the test and keep the same mind doing BMD test for patient. In precision test, the difference of measured value is usually found for ROI change caused by patient position. In case of osteoporosis patient, there is difficult to make initial ROI accurately more than normal and osteopenia patient due to lack of bone recognition even though ROI is made automatically by computer software. However, initial ROI is very important and users have to make coherent ROI because we use ROI Copy function in a follow up. In this study, we performed precision test considering bone density condition and found LSC value was stayed within 3%. There was no considerable difference. Thus, patient selection could be done regardless of bone density condition.

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Evaluation of Real-time Target Positioning Accuracy in Spinal Radiosurgery (척추방사선수술시 실시간 추적검사에 의한 병소목표점 위치변이 평가)

  • Lee, Dong Joon
    • Progress in Medical Physics
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    • v.24 no.4
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    • pp.290-294
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    • 2013
  • Stereotactic Radiosurgery require high accuracy and precision of patient positioning and target localization. We evaluate the real time positioning accuracy of isocenter using optic guided patient positioning system, ExacTrac (BrainLab, Germany), during spinal radiosurgery procedure. The system is based on real time detect multiple body markers attached on the selected patient skin landmarks. And a custom designed patient positioning verification tool (PPVT) was used to check the patient alignment and correct the patient repositioning before radiosurgery. In this study, We investigate the selected 8 metastatic spinal tumor cases. All type of tumors commonly closed to thoracic spinal code. To evaluate the isocenter positioning, real time patient alignment and positioning monitoring was carried out for comparing the current 3-dimensional position of markers with those of an initial reference positions. For a selected patient case, we have check the isocenter positioning per every 20 millisecond for 45 seconds during spinal radiosurgery. In this study, real time average isocenter positioning translation were $0.07{\pm}0.17$ mm, $0.11{\pm}0.18$ mm, $0.13{\pm}0.26$ mm, and $0.20{\pm}0.37$ mm in the x (lateral), y (longitudinal), z (vertical) directions and mean spatial error, respectively. And body rotations were $0.14{\pm}0.07^{\circ}$, $0.11{\pm}0.07^{\circ}$, $0.03{\pm}0.04^{\circ}$ in longitudinal, lateral, table directions and mean body rotation $0.20{\pm}0.11^{\circ}$, respectively. In this study, the maximum mean deviation of real time isocenter positioning translation during spinal radiosurgery was acceptable accuracy clinically.

Bioequivqlence of Gabarep Tablet to Neurotin Tablet (Gabapentin 800 mg) (가바렙정 (가바펜틴 800 mg)의 생물학적 동등성 평가)

  • Seo, Young-Hwan;Jeong, Ju-Cheol;Lee, Jae-Young;Li, Zheng-Yi;Yoon, Hyoung-Jong;Sohn, Uy-Dong;Bang, Joon-Seok;Kim, Ho-Hyun;Jeong, Ji-Hoon
    • Journal of Pharmaceutical Investigation
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    • v.38 no.4
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    • pp.261-267
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    • 2008
  • The aim of the present study was to evaluate the bioequivalence of two gabapentin preparations. We used Neurontin tablet 800 mg (Pfizer Korea Inc.) as a reference drug for bioequivalence of Gabalep tablet 800 mg (Chong Kun Dang Pharmaceutical Co., Korea), and performed this whole study according to the guidelines of Korea Food and Drug Administration (KFDA). Twenty five healthy male volunteers were administered with each drug in a randomized $2{\times}2$ cross-over study with one week washout interval. After drug administration, blood was taken at predetermined time intervals ($0{\sim}24$ hours) and the concentrations of gabapentin in serum were determined using an high performance liquid chromatography-tandem mass spectrometer (LC-MS/MS) employing electrospray ionization technique and operating in multiple reaction mornitoring (MRM). The analytical method was validated in specificity, accuracy, precision and linearity. The phar-macokinetic parameters such as AUCt and Cmax were calculated and ANOVA test was utilized for the statistical analysis of the parameters using logarithmically transformed AUCt and Cmax. $Mean{\pm}SD$. of AUCt and Cmax value for reference drug and test drug were $29.94{\pm}9.23\;({\mu}g/mL{\cdot}hr)$ and $3.12{\pm}1.11\;({\mu}g/mL{\cdot}hr)$, and $31.48{\pm}9.77\;({\mu}g/mL{\cdot}hr)$ and $3.15{\pm}1.03\;({\mu}g/mL)$, respectively. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of log(0.8) to log(1.25) for AUCt and Cmax, respectively. These results indicate that Gabalep tablet 800 mg is bioequivalent to Neurontin tablet 800 mg.

Kinetic behavior of sophoricoside by gas chromatography/mass spectrometry in rats

  • Jeon, Hee-Kyung;Park, Hae-Yeon;Kim, Youn-Jung;Kim, Youngsoo;Kim, Mi-Kyung;Lee, Seung-Ho;Jung, Sang-Hun;Ryu, Jae-Chun
    • Proceedings of the Korea Society of Environmental Toocicology Conference
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    • 2003.05a
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    • pp.189-189
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    • 2003
  • Sophoricoside was isolated as the inhibitor of IL-5 bioactivity from Sophora japonica (Leguminosae). To develope as novel anti-allergic drug, kinetic study was performed in rats. Serum concentration of sophoricoside was measured by gas chromatography-mass spectrometry (GC/MS) in male Sprague-Dawley rat (250${\pm}$10g, n=5) after oral administration of sophoricoside (100mg/kg). The recovery of sophoricoside after extraction and concentration was above 95 % from rat serum. Between-day precision(relative standard deviation 2.2-2.8%) and within-day precision(2.0-12.1%) were determined from replicate analysis of a spiked control and incurred serum sample. The detection limits of sophoricoside in this serum was approximately 0.1 ng/mL. The Pharmacokinetic parameters were derived from the noncompartmental analysis. The C$\_$max/(3.56${\pm}$0.34 $\mu\textrm{g}$/mL) value for sophoricoside in male rat was observed at 7.6 h. The elimination half-life(t$\_$1/2/) of sophoricoside was approximately 4.47 h, the mean residence time (MRT) averaged 10.75 h, the total body clearance (Cl) averaged 0.0042 mL/min/kg. and the area under the serum concentration-time curve (AUC$\_$0-$\infty$/) was 24.93 $\mu\textrm{g}$$.$hr/mL.

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