• Translational and Clinical Pharmacology
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• v.25 no.3
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• pp.153-156
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• 2017

UI14SDF100CW is a chewable tablet of sildenafil citrate, which was developed to improve compliance through convenience of administration. The purpose of this study was to compare the pharmacokinetic (PK) properties of sildenafil citrate chewable tablets (UI14SDF100CW) and conventional sildenafil citrate film-coated tablets ($Viagra^{(R)}$, Pfizer). A randomized, open-label, single dose, two-treatment, two-period, two-way crossover study was conducted in 60 healthy male volunteers. In each period, the subjects received a single oral dose of UI14SDF100CW or $Viagra^{(R)}$ (both tablets contain 140.45 mg of sildenafil citrate, which is equivalent to 100 mg of sildenafil). Serial blood samples were collected up to 24 h post-dose for PK analysis. The plasma concentration of sildenafil was determined using a validated HPLC-MS/MS assay. PK parameters of sildenafil were calculated using non-compartmental methods. The plasma concentration-time profiles of sildenafil in both formulations were similar. For UI14SDF100CW, the $C_{max}$ and $AUC_{last}$ of sildenafil were $1068.69{\pm}458.25$ (mean${\pm}$standard deviation) mg/L and $3580.59{\pm}1680.29h{\cdot}mg/L$, and the corresponding values for $Viagra^{(R)}$ were $1146.84{\pm}501.70mg/L$ and $3406.35{\pm}1452.31h{\cdot}mg/L$, respectively. The geometric mean ratios (90% confidence intervals) of UI14SDF100CW to $Viagra^{(R)}$ for $C_{max}$ and $AUC_{last}$ were 0.933 (0.853-1.021) and 1.034 (0.969-1.108), respectively, which met the bioequivalence criteria of Korean regulatory agency. In conclusion, UI14SDF100CW and $Viagra^{(R)}$ showed similar PK properties. Therefore, UI14SDF100CW can be an alternative to sildenafil for the treatment of erectile dysfunction, providing better compliance.

• Korea Trade Review
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• v.43 no.1
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• pp.109-130
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• 2018

The cumulative standard is one of the criteria determining the origin of imported goods and is a provision that allows non-origin materials to be treated as origin goods when satisfying certain conditions. Regarding the Korea-Canada FTA, new cumulative standards were applied concerning cross accumulation of automobile products. It would benefit U.S. originating intermediate goods of HS code chapter 84, 85, 87, and 94 obtained into HS code heading from 8701 into 8706. We examine the effectiveness of crossover cumulative standards through the change in the import values of 84, 85, 87, 94, which are target items for cross cumulation. Only items designated for automobile parts were selected and analyzed. From the estimation results, significant changes appeared in 20 of the 35 items. It was found that the import amount increased significantly as of January 2015 or the rate of change in trend increases more than before. In addition, the estimation results show that Korean auto companies utilizing the cumulative standards through increased imports of auto parts form the U.S.

• Korean Journal of Radiology
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• v.20 no.5
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• pp.812-822
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• 2019

Objective: To assess the diagnostic value of combining diffusion-weighted imaging (DWI) with conventional magnetic resonance imaging (MRI) for differentiating between pathologic and traumatic fractures at extremities from metastasis. Materials and Methods: Institutional Review Board approved this retrospective study and informed consent was waived. This study included 49 patients each with pathologic and traumatic fractures at extremities. The patients underwent conventional MRI combined with DWI. For qualitative analysis, two radiologists (R1 and R2) independently reviewed three imaging sets with a crossover design using a 5-point scale and a 3-scale confidence level: DWI plus non-enhanced MRI (NEMR; DW set), NEMR plus contrast-enhanced fat-saturated T1-weighted imaging (CEFST1; CE set), and DWI plus NEMR plus CEFST1 (combined set). McNemar's test was used to compare the diagnostic performances among three sets and perform subgroup analyses (single vs. multiple bone abnormality, absence/presence of extra-osseous mass, and bone enhancement at fracture margin). Results: Compared to the CE set, the combined set showed improved diagnostic accuracy (R1, 84.7 vs. 95.9%; R2, 91.8 vs. 95.9%, p < 0.05) and specificity (R1, 71.4% vs. 93.9%, p < 0.005; R2, 85.7% vs. 98%, p = 0.07), with no difference in sensitivities (p > 0.05). In cases of absent extra-osseous soft tissue mass and present fracture site enhancement, the combined set showed improved accuracy (R1, 82.9-84.4% vs. 95.6-96.3%, p < 0.05; R2, 90.2-91.1% vs. 95.1-95.6%, p < 0.05) and specificity (R1, 68.3-72.9% vs. 92.7-95.8%, p < 0.005; R2, 83.0-85.4% vs. 97.6-98.0%, p = 0.07). Conclusion: Combining DWI with conventional MRI improved the diagnostic accuracy and specificity while retaining sensitivity for differentiating between pathologic and traumatic fractures from metastasis at extremities.

• Korean Journal of Psychosomatic Medicine
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• v.27 no.2
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• pp.147-154
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• 2019

Objectives : Cognitive dysfunction, including inattention, is often observed in patients with depression. Inattentive symptoms in patients with depression is similar to those among attention deficit/hyperactivity disorder (ADHD) patients. It is important to diagnose the two diseases accurately, because the treatment varies depending on the cause of inattention. This study aimed to investigate the coexistence rate of ADHD and the correlation between ADHD symptoms and depression in patients with depression. Methods : Participants in this study were 158 outpatients presenting with depression, who visited the psychiatric department from March 2015 to July 2018. Participants divided into a depression and a non-depression group according to the Korean version of the Center for Epidemiological Studies-Depression Scale (CES-D) score and were administered the following : a sociodemographic variables form (age, sex, academic background, occupation), the self-reporting test for adult ADHD (Adult Attention Deficit/Hyperactivity Disorder self-report scale-V 1.1; ASRS V1.1), and the Korean version of the Connors adult ADHD rating scale (K-CAARS). Descriptive statistical analysis, crossover analysis, t-tests, and Pearson's correlation coefficient were conducted on the data. Results : The coexistence rate of adult ADHD symptom was as high as 36.7% in patients with depression (p<0.001). In K-CAARS, the depression group (Inattention=1.80, Hyperactivity=1.92, Impulsivity=1.56, Self-concept=2.06) showed higher average scores on ADHD symptoms than the non-depressive group (Inattention=1.28, Hyperactivity=1.25, Impulsivity=1.09, Self-concept=1.42, p<0.001). Conclusions : This study confirmed that ADHD symptoms coexist in the depression group. When evaluating the symptoms of patients who complain of depression, it is suggested that they should be accurately diagnosed and appropriately treated with interest to the coexistence of ADHD symptoms and the possibility for ADHD diagnosis.