• Environmental Analysis Health and Toxicology
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• v.31
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• pp.26.1-26.9
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• 2016

Objectives Korea's Act on the Registration and Evaluation of Chemicals (K-REACH) was enacted for the protection of human health and the environment in 2015. Considering that about 2000 new substances are introduced annually across the globe, the extent of animal testing requirement could be overwhelming unless regulators and companies work proactively to institute and enforce global best practices to replace, reduce or refine animal use. In this review, the way to reduce the animal use for K-REACH is discussed. Methods Background of the enforcement of the K-REACH and its details was reviewed along with the papers and regulatory documents regarding the limitation of animal experiments and its alternatives in order to discuss the regulatory adoption of alternative tests. Results Depending on the tonnage of the chemical used, the data required ranges from acute and other short-term studies for a single exposure route to testing via multiple exposure routes and costly, longer-term studies such as a full two-generation reproducibility toxicity. The European Registration, Evaluation, Authorization and Restriction of Chemicals regulation provides for mandatory sharing of vertebrate test data to avoid unnecessary duplication of animal use and test costs, and obligation to revise data requirements and test guidelines "as soon as possible" after relevant, validated replacement, reduction or refinement (3R) methods become available. Furthermore, the Organization for Economic Cooperation and Development actively accepts alternative animal tests and 3R to chemical toxicity tests. Conclusions Alternative tests which are more ethical and efficient than animal experiments should be widely used to assess the toxicity of chemicals for K-REACH registration. The relevant regulatory agencies will have to make efforts to actively adopt and uptake new alternative tests and 3R to K-REACH.

• Journal of Oral Medicine and Pain
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• v.20 no.2
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• pp.291-306
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• 1995

Mandibular movement is composed of border movement and functional movement. Border movement such as maximal mouth opening, hinge opening ad lateral eccentric movement has good reproducibility, but functional movement such as chewing, swallowing and speech has also reproducibility. Especially for chewing movement, individual reproducibility has been confirmed by many studies. Study of chewing pattern is still in controversy. In new approach for raising the diagnostic value, numeric parameters and morphologic characteristics could be used for evaluation of chewing pattern. This study was performed to investigate the differences between chewing pattern in controls and in patients with temporomandibular disorders. Sixty-three patients with temporomandibular disorders participated in this study, and they were divided into unilaterally affected subjects or bilaterally affected subjects. Then unilaterally affected subjects were classified into closed lock group, disk displacement with reduction group, and degenerative joint disease group. For recording of chewing pattern, subjects were asked to chew one piece of presoftened chewing gum on both sides, and the chewing movement was recorded with the Electrognatho- Graphy(Bio-Research Associates Inc., U.S.A.). Tooth contact pattern for occlusal stability (Total left-right statistics )was also recorded with T-Scan(Tekscan Co., U.S.A.). The dta related to chewing pattern and total left-right statistics were statistically analyzed by SAS/stat program. The obtained results were as follows : 1. In patient group, mean value of A-P distance and the ratio of A-P distance to vertical distance were larger than control group, but the value of lateral distance in affected side and the closing velocity in unaffected side were smaller than that of control group, respectively. 2. In case of unilateral affected patients, chewing pattern of other side had tendency to restricted movement and slow velocity in closed lock group or degenerative joint disease group than control group or disk displacement with reduction group. 3. In bilateral degenerative joint disease patients, contralateral side had tendency to large range of motion and slow chewing velocity than preferred chewing side. 4. The patients with restricted mouth opening below than 35mm had higher value of total left-right statistics than patient group mouth opening above 35mm. Also closed lock group had higher total left-right statistics than disk displacement with reduction group, degenerative joint disease group and control group. 5. There was some difference in morphologic characteristics of chewing pattern between in control group and in affected side of unilateral patient group, but no difference between control group and unaffected side of unilateral patient group. 6. There were positive correlations between vertical distance and A-P distance, between vertical distance and chewing velocity, between A-P distance and chewing velocity, and between opening velocity and closing velocity in unilateral affected patients.

• The Journal of Advanced Prosthodontics
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• v.6 no.2
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• pp.71-78
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• 2014

PURPOSE. The objective of this study was to evaluate the clinical acceptability of all-ceramic crowns fabricated by the digital veneering method vis-$\grave{a}$-vis the traditional method. MATERIALS AND METHODS. Zirconia specimens manufactures by two different manufacturing method, conventional vs digital veneering, with three different thickness (0.3 mm, 0.5 mm, 0.7 mm) were prepared for analysis. Color measurement was performed using a spectrophotometer for the prepared specimens. The differences in shade in relation to the build-up method were calculated by quantifying ${\Delta}E^*$ (mean color difference), with the use of color difference equations representing the distance from the measured values $L^*$, $a^*$, and $b^*$, to the three-dimensional space of two colors. Two-way analysis of variance (ANOVA) combined with a Tukey multiple-range test was used to analyze the data (${\alpha}$=0.05). RESULTS. In comparing means and standard deviations of $L^*$, $a^*$*, and $b^*$ color values there was no significant difference by the manufacturing method and zirconia core thickness according to a two-way ANOVA. The color differences between two manufacturing methods were in a clinically acceptable range less than or equal to 3.7 in all the specimens. CONCLUSION. Based on the results of this study, a carefully consideration is necessary while selecting upper porcelain materials, even if it is performed on a small scale. However, because the color reproducibility of the digital veneering system was within the clinically acceptable range when comparing with conventional layering system, it was possible to estimate the possibility of successful aesthetic prostheses in the latest technology.

• Journal of radiological science and technology
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• v.33 no.3
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• pp.289-294
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• 2010

The purpose of this study is an evaluation of the performance of a detector under radiographic irradiation condition by fabricating the polycrystalline $HgI_2$ film detector. The polycrystalline $HgI_2$ film detectors with thickness of 210 and $320\;{\mu}m$ were fabricated by screen print technology. Measurements of X-ray sensitivity and dark current were performed for two detectors. And measurements of the linearity of X-ray response and reproducibility were performed for the detector of thickness $320\;{\mu}m$. For applied electric field strengths from 0.05 to $2\;V/{\mu}m$ to the detector of thickness $320\;{\mu}m$, the X-ray sensitivities were measured from 233 to $1,408{\times}106\;electrons/mR{\cdot}mm^2$. And the dark currents were measured from 3.2 to $118\;pA/mm^2$. Compared with values reported by Zhong Su et al., the X-ray sensitivities exhibit about two times larger than the X-ray sensitivities measured by Zhong Su et al. And the dark currents exhibit about nine times larger than the dark currents measured by Zhong Su et al. The linearity of X-ray response acquired 0.988 as a coefficient of correlation (r). Reproducibility acquired 0.002 as a coefficient of variation. This study provides the performance data of fabricated polycrystalline $HgI_2$ film detector available for an active matrix flat panel imager under radiographic irradiation condition.

• Imaging Science in Dentistry
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• v.37 no.3
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• pp.165-170
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• 2007

Purpose: To estimate the shape of root and pulp canal using a dental cone beam computed tomography (CBCT) and to evaluate the accuracy of imaging reformation. Materials and Methods: CBCT images were obtained with incisors, premolars, and molars as the destination by using PSR $9000N^{TM}$ Dental CT system (Asahi Roentgen Ind. Co., Ltd, Kyoto, Japan) and i-CAT (Imaging Sciences International, Inc, USA) cone beam CT unit that have different kind of detector and field of view, and compared these with the shape and the size of actual root and root canal. Results: When the measuring value of cone beam computed tomography concerning to each root's bucco-lingual diameter and mesio-distal diameter was compared with the value of the actual root, it reveals an error range $-0.49{\sim}+0.63$ mm at PSR900N and $-0.97{\sim}+1.14$ mm at i-CAT (P>0.05). It was possible to identify and measure PSR$9000N^{TM}$ Dental CT system to the limit $0.48{\pm}0.06mm$ (P>0.05) and i-CAT CBCT to the limit $0.86{\pm}0.09mm$ (P<0.05) on estimating the size and the shape of root canal. Two kinds of CBCT images revealed the useful reproducibility to estimate the shape of root, but there was the difference to estimate the shape of root according to apparatus. The reproducibility of root shape in the image of three-dimensions at PSR 900N is low such as 0.65 mm in a case of minute root canal. Conclusions: CBCT images revealed higher accuracy of the imaging reformation for root and pulp and clinically CBCT is a useful diagnostic tool for the assessment of root and canal. However, there are different qualities of imaging reformation according to CBCT apparatus and limitation of reproducibility for minute root canals.

• Journal of the Korean Society of Radiology
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• v.17 no.6
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• pp.919-927
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• 2023

Elastography utilizes the fact that the tissue of a malignant tumor is harder than that of a benign tumor and increases the specificity of diagnosis according to the elastic modulus of the tumor, helping to reduce unnecessary biopsies. However, the reliability of elastography can be influenced by the equipment used and the examiner's skills. In this study, the researchers analyzed the reproducibility of elastography by evaluating phantom images when measuring the elasticity values repeatedly. Phantoms were created using silicone and gelatin with different levels of stiffness, and they were inserted at varying depths from the surface. The elasticity values were measured using shear wave elastography. The study aimed to determine whether the reproducibility of elasticity values remains consistent depending on the stiffness and depth of the lesions. The experimental results showed that there was no statistically significant correlation between the elasticity values obtained through shear wave elastography and the depth or stiffness of the lesions. However, in the lesions with the lowest stiffness, the elasticity values were statistically significant (p<0.001) and showed a high correlation with the depth of the lesions. Although there were variations in the measured elasticity values based on the differences in lesion stiffness and depth, these differences did not significantly impact the diagnosis. Therefore, shear wave elastography remains a reliable diagnostic method, and it is suggested that it can be helpful in the diagnosis of breast lesions.

• Proceedings of the KIEE Conference
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• 2004.11c
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• pp.322-324
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• 2004

Up to the present, digital replantation patients has appealed different symptoms due to blood circulatory failure. But, the level of blood circulatory failure has been evaluated only by clinical symptoms, or angiography. According to the cases of digit replantation is increasing, then objective evaluation methods of the level of blood circulation failure is needed other than patient's subjective symptoms and complaints. Although angiography, doppler, electromagnetic flowmeter, laser blood flowmeter, mechanical blood flowmeter has been used for the evaluation of the blood circulatory failure, the result was affected by time, place, surrounding temperature, patient's body temperature, and even emotion. Therefore, it is pointed out with lack of availability, feasibility and reproducibility. Thus, we compared digital blood flow of dominant hand to non dominant hand, and replanted fingers to opposite normal fingers from developed photo-plethysmography. The average digital blood flow showed no difference in normal digits each other, but, replanted digits showed average of 53% (9 - 100 %) compare to opposit normal digits. As it measure relative blood flow for circulatory failure of tissue such as fingers and toes more sensitively, reliably. In conclusion, it is expected that photo- plethysmography will be very useful for diagnosis, curative effect, prognosis of blood circulatory failure in digital replantation patient.

• Proceedings of the Korean Society of Medical Physics Conference
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• 2002.09a
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• pp.103-105
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• 2002

Whole body stereotactic radiosurgery (WBSRS) technique is believed to be useful for the metastatic lesions as well as relatively small primary tumors in the trunk. Unlike stereotactic radiosurgery to intracranial lesion, inherent limitation on immobilization of whole body makes it difficult to achieve the reliable setup reproducibility. For this reason, it is essential to develop an objective and quantitative method of evaluating setup error for WBSRS. An evaluation technique using image registration has been developed for this purpose. Point pair image registrations with WBSRS frame coordinates were performed between two sets of CT images acquired before each treatment. Positional displacements could be determined by means of volumetric planning target volume (PTV) comparison between the reference and the registered image sets. Twenty eight sets of CT images from 19 WBSRS patients treated in Asan Medical Center have been analyzed by this method for determination of setup random error of each treatment. It is objective and clinically useful to analyze setup error quantitatively by image registration technique with WBSRS frame coordinates.

• Journal of the Korean Society of Tobacco Science
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• v.20 no.1
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• pp.108-114
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• 1998

This study was conducted to evaluate the techniques or analyzing tobacco smoke by statistical treatment method for the analytical data through Asia Collaborative Study V. In addition to five smoke components analysis, consisting of TPM, water, nicotine, NFDPM, and puff count of four cigarettes samples, statistical parameters such as mean, standard deviation, box-and-whisker plots, h plots, k plots, regression coefficients, reproducibility (R), and repeatability (r) were also calculated. Analysis of water content of cigarette smoke was the most difficult task, whereas puff count analysis was the easiest as well recognized by all laboratories. Analysis of nicotine and puff count accounted for both the lowest and the highest variation among four parameters. The water coefficients indicated more randomness or variation in the slops. The NFDPM data exhibited both types of deviations from linearity. Water content of sample D indicated the highest difference between two single results and between two interlaboratory test results. As a whole, KGTRI ranked higher in the analytical techniques for statistical evaluation of results when compared with the practices of 28 other laboratories.

• International Journal of Stem Cells
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• v.17 no.2
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• pp.120-129
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• 2024

Recent amendments to regulatory frameworks have placed a greater emphasis on the utilization of in vitro testing platforms for preclinical drug evaluations and toxicity assessments. This requires advanced tissue models capable of accurately replicating liver functions for drug efficacy and toxicity predictions. Liver organoids, derived from human cell sources, offer promise as a reliable platform for drug evaluation. However, there is a lack of standardized quality evaluation methods, which hinders their regulatory acceptance. This paper proposes comprehensive quality standards tailored for liver organoids, addressing cell source validation, organoid generation, and functional assessment. These guidelines aim to enhance reproducibility and accuracy in toxicity testing, thereby accelerating the adoption of organoids as a reliable alternative or complementary tool to animal testing in drug development. The quality standards include criteria for size, cellular composition, gene expression, and functional assays, thus ensuring a robust hepatotoxicity testing platform.