• Title/Summary/Keyword: critical parameters

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A Comparative Study on the Regulations on Implantable Bioabsorbable Combination Products -Focusing on the U.S., Europe and Korea- (이식형 흡수성 융복합 의료제품 규제 비교 연구 -미국, 유럽, 한국을 중심으로-)

  • Hyeon Jeong Lee;Mi Hye Kim;Ju Eun Seol;Su Dong Kim;Joo Hee Kim
    • Journal of Biomedical Engineering Research
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    • v.44 no.6
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    • pp.414-427
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    • 2023
  • Implantable bioabsorbable combination products undergo inherent degradation and systemic absorption within the physiological environment, thereby streamlining the therapeutic regimen and obviating the imperative for invasive extraction procedures. This inherent property not only enhances patient convenience and therapeutic efficacy but also underpins a paradigm of support characterized by heightened safety parameters. Within the regulatory landscapes of Korea, the United States, and Europe, implantable bioabsorbable combination products are meticulously classified into distinct categories, either as pharmaceutical implants or as implantable medical devices, depending on their primary mode of action. This scholarly investigation systematically examines the regulatory frameworks governing implantable bioabsorbable combination products in South Korea, the United States, and Europe. Notable discrepancies across national jurisdictions emerge concerning regulatory specifics, including terminology, product classification, and product name associated with these products. The conspicuous absence of standardized approval regulations presents a formidable barrier to the commercialization of these advanced medical devices. This academic discourse passionately emphasizes the critical need for formulating and implementing a sophisticated regulatory framework capable of streamlining the product approval process, thereby paving the way for a seamless path to commercializing implantable bioabsorbable combination products.

Propagation Characteristics of Ground Vibration Caused by Blast Hole Explosion of High Explosives in Granite (고위력 폭약의 화강암 내 장약공 폭발에 의한 지반진동 전파특성에 관한 연구)

  • Gyeong-Gyu Kim;Chan-Hwi Shin;Han-Lim Kim;Ju-Suk Yang;Sang-Ho Bae;Kyung-Jae Yun;Sang-Ho Cho
    • Explosives and Blasting
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    • v.41 no.4
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    • pp.29-40
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    • 2023
  • Rock blasting is utilized in various fields such as mining, tunneling, and the construction of underground structures. The role of rock blasting technology has became increasingly significant with the growing utilization of underground cavity. Blast hole pressure, generated during rock blasting, is a critical variable directly impacting factors such as crushing and blast vibration. It stands out as one of the most important parameters for assessing explosive performance and predicting blasting effects. While blast hole pressure has been studied by several researches, comparisons are challenging due to variations in experimental conditions such as explosive type, charge, and blasting conditions. In this study, blast hole pressure sensors and observation hole pressure sensors were developed to measure pressure during single-hole blasting, The experimental results were then used to discuss the propagation characteristics of pressure around the blast hole and the corresponding blast vibration.

Application of T1 Map Information Based on Synthetic MRI for Dynamic Contrast-Enhanced Imaging: A Comparison Study with the Fixed Baseline T1 Value Method

  • Dong Jae Shin;Seung Hong Choi;Roh-Eul Yoo;Koung Mi Kang;Tae Jin Yun;Ji-Hoon Kim;Chul-Ho Sohn;Sang Won Jo;Eun Jung Lee
    • Korean Journal of Radiology
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    • v.22 no.8
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    • pp.1352-1368
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    • 2021
  • Objective: For an accurate dynamic contrast-enhanced (DCE) MRI analysis, exact baseline T1 mapping is critical. The purpose of this study was to compare the pharmacokinetic parameters of DCE MRI using synthetic MRI with those using fixed baseline T1 values. Materials and Methods: This retrospective study included 102 patients who underwent both DCE and synthetic brain MRI. Two methods were set for the baseline T1: one using the fixed value and the other using the T1 map from synthetic MRI. The volume transfer constant (Ktrans), volume of the vascular plasma space (vp), and the volume of the extravascular extracellular space (ve) were compared between the two methods. The interclass correlation coefficients and the Bland-Altman method were used to assess the reliability. Results: In normal-appearing frontal white matter (WM), the mean values of Ktrans, ve, and vp were significantly higher in the fixed value method than in the T1 map method. In the normal-appearing occipital WM, the mean values of ve and vp were significantly higher in the fixed value method. In the putamen and head of the caudate nucleus, the mean values of Ktrans, ve, and vp were significantly lower in the fixed value method. In addition, the T1 map method showed comparable interobserver agreements with the fixed baseline T1 value method. Conclusion: The T1 map method using synthetic MRI may be useful for reflecting individual differences and reliable measurements in clinical applications of DCE MRI.

Optimization and Bioassay Guided Comparative Techniques for Efficient Extraction of Lutein Esters from Tagetes erecta (Var. Pusa Narangi Genda) Flowers

  • Kawar Lal Dabodhia;Brijesh Tripathi;Narendra Pal Lamba;Manmohan Singh Chauhan;Rohit Bhatia;Vivek Mishra
    • Mass Spectrometry Letters
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    • v.15 no.1
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    • pp.40-48
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    • 2024
  • Capacity of the analytical/quantitative evaluation techniques to satisfy both qualitative and quantitative considerations for effective extraction of marigold oleoresins/xanthophylls and their potential as anti-mycotic and antioxidant activity was assessed. Accelerated solvent extraction (ASE), Soxhlet extraction (SE), Supercritical fluid extraction (SCFE), Cold extraction (CE), and ultrasonically assisted extraction (USE) techniques were evaluated for extraction of oleoresin/xanthophyll content from Tagetes erecta (Var. Pusa Narangi Genda) with respect to solvent consumption, extraction time, reproducibility, and yield. Followed by the antifungal and antioxidant activity evaluation. The overall yield of Tagetes oleoresin was higher in ASE (64.5 g/kg) followed by SE (57.3 g/kg), USE (50.7 g/kg), SCFE (45.3 g/kg) and CE (31.6 g/kg). The lutein esters represented more than 80% of the constituents. Further, xanthophyll/ lutein content in oleoresin was found to be quite higher in HPLC (r2 = 0.996) analysis than in the AOAC recommended UV spectrophotometer analysis. The oleoresin exhibited moderate antioxidant activity (DPPH assay) and antifungal activity against three phytopathogenic fungi. Based on the various parameters, the reproducibility of ASE was better (0.3-8.0%) than that of SE (0.5-12.9%), SCFE (0.2-9.4%), USE (0.3-12.4%) and CE (0.8-15.3%). ASE with (RSD 1.6%) is preferred being faster, reproducible, uses less solvent, robust and automation allows sequential extraction of the sample in less time.

Critical Adjuvant Influences on Preventive Anti-Metastasis Vaccine Using a Structural Epitope Derived from Membrane Type Protease PRSS14

  • Ki Yeon Kim;Eun Hye Cho;Minsang Yoon;Moon Gyo Kim
    • IMMUNE NETWORK
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    • v.20 no.4
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    • pp.33.1-33.19
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    • 2020
  • We tested how adjuvants effect in a cancer vaccine model using an epitope derived from an autoactivation loop of membrane-type protease serine protease 14 (PRSS14; loop metavaccine) in mouse mammary tumor virus (MMTV)-polyoma middle tumor-antigen (PyMT) system and in 2 other orthotopic mouse systems. Earlier, we reported that loop metavaccine effectively prevented progression and metastasis regardless of adjuvant types and TH types of hosts in tail-vein injection systems. However, the loop metavaccine with Freund's complete adjuvant (CFA) reduced cancer progression and metastasis while that with alum, to our surprise, were adversely affected in 3 tumor bearing mouse models. The amounts of loop peptide specific antibodies inversely correlated with tumor burden and metastasis, meanwhile both TH1 and TH2 isotypes were present regardless of host type and adjuvant. Tumor infiltrating myeloid cells such as eosinophil, monocyte, and neutrophil were asymmetrically distributed among 2 adjuvant groups with loop metavaccine. Systemic expression profiling using the lymph nodes of the differentially immunized MMTV-PyMT mouse revealed that adjuvant types, as well as loop metavaccine can change the immune signatures. Specifically, loop metavaccine itself induces TH2 and TH17 responses but reduces TH1 and Treg responses regardless of adjuvant type, whereas CFA but not alum increased follicular TH response. Among the myeloid signatures, eosinophil was most distinct between CFA and alum. Survival analysis of breast cancer patients showed that eosinophil chemokines can be useful prognostic factors in PRSS14 positive patients. Based on these observations, we concluded that multiple immune parameters are to be considered when applying a vaccine strategy to cancer patients.

In-depth exploration of machine learning algorithms for predicting sidewall displacement in underground caverns

  • Hanan Samadi;Abed Alanazi;Sabih Hashim Muhodir;Shtwai Alsubai;Abdullah Alqahtani;Mehrez Marzougui
    • Geomechanics and Engineering
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    • v.37 no.4
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    • pp.307-321
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    • 2024
  • This paper delves into the critical assessment of predicting sidewall displacement in underground caverns through the application of nine distinct machine learning techniques. The accurate prediction of sidewall displacement is essential for ensuring the structural safety and stability of underground caverns, which are prone to various geological challenges. The dataset utilized in this study comprises a total of 310 data points, each containing 13 relevant parameters extracted from 10 underground cavern projects located in Iran and other regions. To facilitate a comprehensive evaluation, the dataset is evenly divided into training and testing subset. The study employs a diverse array of machine learning models, including recurrent neural network, back-propagation neural network, K-nearest neighbors, normalized and ordinary radial basis function, support vector machine, weight estimation, feed-forward stepwise regression, and fuzzy inference system. These models are leveraged to develop predictive models that can accurately forecast sidewall displacement in underground caverns. The training phase involves utilizing 80% of the dataset (248 data points) to train the models, while the remaining 20% (62 data points) are used for testing and validation purposes. The findings of the study highlight the back-propagation neural network (BPNN) model as the most effective in providing accurate predictions. The BPNN model demonstrates a remarkably high correlation coefficient (R2 = 0.99) and a low error rate (RMSE = 4.27E-05), indicating its superior performance in predicting sidewall displacement in underground caverns. This research contributes valuable insights into the application of machine learning techniques for enhancing the safety and stability of underground structures.

Assessment of nonlocal nonlinear free vibration of bi-directional functionally-graded Timoshenko nanobeams

  • Elnaz Zare;Daria K. Voronkova;Omid Faraji;Hamidreza Aghajanirefah;Hamid Malek Nia;Mohammad Gholami;Mojtaba Gorji Azandariani
    • Advances in nano research
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    • v.16 no.5
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    • pp.473-487
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    • 2024
  • The current study employs the nonlocal Timoshenko beam (NTB) theory and von-Kármán's geometric nonlinearity to develop a non-classic beam model for evaluating the nonlinear free vibration of bi-directional functionally-graded (BFG) nanobeams. In order to avoid the stretching-bending coupling in the equations of motion, the problem is formulated based on the physical middle surface. The governing equations of motion and the relevant boundary conditions have been determined using Hamilton's principle, followed by discretization using the differential quadrature method (DQM). To determine the frequencies of nonlinear vibrations in the BFG nanobeams, a direct iterative algorithm is used for solving the discretized underlying equations. The model verification is conducted by making a comparison between the obtained results and benchmark results reported in prior studies. In the present work, the effects of amplitude ratio, nanobeam length, material distribution, nonlocality, and boundary conditions are examined on the nonlinear frequency of BFG nanobeams through a parametric study. As a main result, it is observed that the nonlinear vibration frequencies are greater than the linear vibration frequencies for the same amplitude of the nonlinear oscillator. The study finds that the difference between the dimensionless linear frequency and the nonlinear frequency is smaller for CC nanobeams compared to SS nanobeams, particularly within the α range of 0 to 1.5, where the impact of geometric nonlinearity on CC nanobeams can be disregarded. Furthermore, the nonlinear frequency ratio exhibits an increasing trend as the parameter µ is incremented, with a diminishing dependency on nanobeam length (L). Additionally, it is established that as the nanobeam length increases, a critical point is reached at which a sharp rise in the nonlinear frequency ratio occurs, particularly within the nanobeam length range of 10 nm to 30 nm. These findings collectively contribute to a comprehensive understanding of the nonlinear vibration behavior of BFG nanobeams in relation to various parameters.

Static analysis of nonlinear FG-CNT reinforced nano-composite beam resting on Winkler/Pasternak foundation

  • Mostefa Sekkak;Rachid Zerrouki;Mohamed Zidour;Abdelouahed Tounsi;Mohamed Bourada;Mahmoud M Selim;Hosam A. Saad
    • Advances in nano research
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    • v.16 no.5
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    • pp.509-519
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    • 2024
  • In this study, the static analysis of carbon nanotube-reinforced composites (CNTRC) beams resting on a Winkler-Pasternak elastic foundation is presented. The developed theories account for higher-order variation of transverse shear strain through the depth of the beam and satisfy the stress-free boundary conditions on the top and bottom surfaces of the beam. To study the effect of carbon nanotubes distribution in functionally graded (FG-CNT), we introduce in the equation of CNT volume fraction a new exponent equation. The SWCNTs are assumed to be aligned and distributed in the polymeric matrix with different patterns of reinforcement. The rule of mixture is used to describe the material properties of the CNTRC beams. The governing equations were derived by employing Hamilton's principle. The models presented in this work are numerically provided to verify the accuracy of the present theory. The analytical solutions are presented, and the obtained results are compared with the existing solutions to verify the validity of the developed theories. Many parameters are investigated, such as the Pasternak shear modulus parameter, the Winkler modulus parameter, the volume fraction, and the order of the exponent in the volume fraction equation. New results obtained from bending and stresses are presented and discussed in detail. From the obtained results, it became clear the influence of the exponential CNTs distribution and Winkler-Pasternak model improved the mechanical properties of the CNTRC beams.

Evaluation of Vulnerability to Groundwater Contamination using Groundwater Quality Characteristics and DRASTIC Index in Miryang City (밀양시 지하수 수질 특성과 DRASTIC 지수를 이용한 지하수 오염취약성 평가)

  • SeongYeon Jung;Sieun Kim;Sul-Min Yun;Jeheon Oh;Chung-Mo Lee
    • Journal of Soil and Groundwater Environment
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    • v.29 no.3
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    • pp.23-36
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    • 2024
  • Miryang City, the study area, has a water supply rate of 87.4%, which is 12% lower than the national water supply rate of 99.4%, but has a high dependence on groundwater due to the high ratio of farms. In agricultural areas, contamination becomes relatively more critical, requiring significant attention to the management and conservation of groundwater resources. This study aims at estimate groundwater vulnerability of Miryang City using the DRASTIC index map, Piper diagram, and water quality data to correlated with the DRASTIC index. The results from DRASTIC map were divided into five classes: very high, high, moderate, low, and very low. The areas in central and southern part of study area, which are characterize by a very high index with [Ca-Cl] and [Na-Cl] water types, covering a large alluvium with the Miryang River and Nakdonggang River. In addition, a correlation analysis between groundwater quality parameters and the DRASTIC index was carried out. Chloride, sodium, and sulfate ions showed a weak relationship with DRASTIC index, with correlation coefficient was 0.507, 0.487 and 0.344, respectively. These results suggest that aquifer media, soil media, hydraulic conductivity, and chloride ion are important factors for groundwater vulnerability.

Distribution of the intraosseous branch of the posterior superior alveolar artery relative to the posterior maxillary teeth

  • Carsen R. McDaniel;Thomas M. Johnson;Brian W. Stancoven;Adam R. Lincicum
    • Imaging Science in Dentistry
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    • v.54 no.2
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    • pp.121-127
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    • 2024
  • Purpose: Preoperative identification of the intraosseous posterior superior alveolar artery (PSAA) is critical when planning sinus surgery. This study was conducted to determine the distance between the cementoenamel junction and the PSAA, as well as to identify factors influencing the detection of the PSAA on cone-beam computed tomography (CBCT). Materials and Methods: In total, 254 CBCT scans of maxillary sinuses, acquired with 2 different scanners, were examined to identify the PSAA. The distance from the cementoenamel junction (CEJ) to the PSAA was recorded at each maxillary posterior tooth position. Binomial logistic regression and multiple linear regression were employed to evaluate the effects of scanner type, CBCT parameters, sex, and age on PSAA detection and CEJ-PSAA distance, respectively. P-values less than 0.05 were considered to indicate statistical significance. Results: The mean CEJ-PSAA distances at the second molar, first molar, second premolar, and first premolar positions were 17.0±4.0 mm, 21.8±4.1 mm, 19.5±4.7 mm, and 19.9±4.9 mm for scanner 1, respectively, and 17.3±3.5 mm, 16.9±4.3 mm, 18.5±4.1 mm, and 18.4±4.3 mm for scanner 2. No independent variable significantly influenced PSAA detection. However, tooth position (b=-0.67, P<0.05) and scanner type (b=-1.3, P<0.05) were significant predictors of CEJ-PSAA distance. Conclusion: CBCT-based estimates of CEJ-PSAA distance were comparable to those obtained in previous studies involving cadavers, CT, and CBCT. The type of CBCT scanner may slightly influence this measurement. No independent variable significantly impacted PSAA detection.