• Title/Summary/Keyword: e-clinical data

Search Result 781, Processing Time 0.042 seconds

Bioequivalence of Hana Loxoprofen Sodium Tablet to Dongwha Loxonin® Tablet (Loxoprofen Sodium 60 mg)

  • Kang, Hyun-Ah;Cho, Hea-Young;Lee, Yong-Bok
    • Journal of Pharmaceutical Investigation
    • /
    • v.41 no.2
    • /
    • pp.117-123
    • /
    • 2011
  • Loxoprofen sodium, a 2-phenylpropionate non-steroidal anti-inflammatory drug (NSAID), has marked analgesic and antipyretic activities and relatively weak gastrointestinal ulcerogenicity. The purpose of the present study was to evaluate the bioequivalence of two loxoprofen sodium tablets, Hana loxoprofen sodium tablet (Hana Pharm. Co., Ltd.) and Dongwha Loxonin$^{(R)}$ tablet (Dongwha Pharm. Co., Ltd.), according to the guidelines of the Korea Food and Drug Administration (KFDA). The in vitro release of loxoprofen from the two loxoprofen sodium formulations was tested using KP IX Apparatus II method with various dissolution media. Twenty four healthy Korean male volunteers, $22.83{\pm}1.862$ years in age and $69.92{\pm}9.14$ kg in body weight, were divided into two groups and a randomized $2{\times}2$ crossover study was employed. After a single tablet containing 60 mg as loxoprofen sodium was orally administered, blood samples were taken at predetermined time intervals and the concentrations of loxoprofen in serum were determined using a online column-switching HPLC method with UV/Vis detection. The dissolution profiles of two formulations were similar in all tested dissolution media. The pharmacokinetic parameters such as $AUC^t$, $C_{max}$ and $T_{max}$ were calculated, and computer programs (Equiv Test and K-BE Test 2002) were utilized for the statistical analysis of the parameters using logarithmically transformed $AUC_t$, $C_{max}$ and un-transformed $T_{max}$. The results showed that the differences between two formulations based on the reference drug, Dongwha Loxonin$^{(R)}$ tablet, were 2.03, 2.99 and -9.49% for $AUC_t$, $C_{max}$, and $T_{max}$, respectively. There were no sequence effects between two formulations in these parameters. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of log0.8 to log1.25 (e.g., log0.9831~log1.0535 and log0.9455~log1.1386 for $AUC_t$ and $C_{max}$, respectively). Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating Hana loxoprofen sodium tablet was bioequivalent to Dongwha Loxonin$^{(R)}$ tablet.

A STUDY OF THE TEMPOROMANDIBULAR JOINT IN NORMAL OCCLUSION USING T.M.J TOMOGRAM AND CEPHALOGRAM (단층 및 두부 방사선 계측사진을 이용한 정상교합자의 악관절에 관한 연구)

  • Baik, Hyoung-Seon
    • The korean journal of orthodontics
    • /
    • v.16 no.1
    • /
    • pp.85-106
    • /
    • 1986
  • The purpose of this investigation was to know the means of the T.M.J. space and to compare spational differences in centric relation and centric occlusion by the T.M.J. Tomogram and to study the correlation between the articular eminence slope and the lingual surface slope of the maxillary central incisor by the Cephalogram in near normal occlusion subjects. These results could give contribution for the diagnosis of orthodontic treatment and T.M.J. dysfunction and the assessment of orthopedic treatment and orthognathic surgery. 44 young adults (28 men and 16 women, 21 to 27 years of age) were selected from the Dental students in Yonsei Univ. Criteria for selection was normal occlusion, no clinical signs and T.M.J. dysfunction, no history of orthodontic treatment, and no missing tooth. After submental vertex view analysis. each subject was given the T.M.J. Tomogram in centric relation and centric occlusion and the Cephalogram was given with Quint Sectograph. All data was recorded and statistically processed with the CYBER computer system. Results were analyzed: the following findings and conclusions were derived. 1. The mean value for the combined right and left anterior joint space was 2.549mm, the posterior space was 2.260mm, and superior space was 3.31mm in centric relation. The anterior space was 2.316mm, posterior space was 2.474mm, and superior space was 3.435mm in centric occlusion. 2. In the centric relation position, both condyles were placed more posterioly and superioly in their fossae than in the centric occlusion position by the spatial difference. 3. In the centric occlusion position, both condyles were more symmetrically placed in their fossae with equal anterior-posterioly rather than in the centric relation position. 4. The mean articular eminence angle was $48.19^{\circ}$ and the mean fossa height was 7.911mm. A strong positive correlation between the articular eminence angle and fossa height in T.M.J. Tomogram was found. 5. In Cephalometric analysis, there was a strong positive correlation between the articular eminence slope and the lingual surface slope of the upper central incisor to the FH plane, occlusal plane, and S-N plane. 6. There was moderate positive correlation between the S-E measurements and the fossa height, articular eminence angle, and DcGn < F-H.

  • PDF

SEASON OF BIRTH, BIRTH ORDER AND MATERNAL AGE IN INFANTILE AUTISM (유아(幼兒) 자폐증(自閉症)의 출생계절(出生季節), 출생순위(出生順位)및 산모연령(産母年齡)에 관한 연구(硏究))

  • Lee, Young-Sik;Min, Kyung-Joon;Choi, Jin-Sook;Kim, Dong-Hyun;Cho, Soo-Churl;Lee, Kil-Hong;Hong, Kang-E
    • Journal of the Korean Academy of Child and Adolescent Psychiatry
    • /
    • v.4 no.1
    • /
    • pp.46-53
    • /
    • 1993
  • To find some involvement of environmental factors in autism, season of birth, birth order, and maternal age at birth of autistic children were investigated Total number of clinical outpatient autistic children was 357, which consisted of 319 male and 38 female, then male-to-female sex ratio was 8.4 to 1, and all subjects were born during $1986{\sim}1988.$ These data were compared with those of controlled general populations. The results were as follows : 1) In monthly and seasonal distributions of birth, autistic children were not different from normal control 2) Comparing with control group by Slater's and Greenwood-Yule's birth order calculation methods, there was no significant difference in birth order of autistic children 3) The maternal ages at birth in autistic group were significantly higher than those of control group(P<01) 4) High-risk pregnancies were significantly frequent in autistic group compared with control group(p<01)Our study supported the idea that at least some environmental factors, especially at-risk pregnancy, are involved in autism causation.

  • PDF

Comparison of Superovulation Outcomes between Short and Long Protocols Using Gonadotropin-Releasing Hormone Agonist in Patients with High Basal Serum Follicle Stimulating Hormone Levels (기초 혈중 Follicle Stimulating Hormone 농도가 높은 체외수정시술 환자의 과배란유도시 Gonadotropin-Releasing Hormone Agonist의 단기투여법과 장기투여법의 비교)

  • Kim, Seok-Hyun;Song, Eun-Seop;Song, Yong-Sang;Lee, Kyung-Hee;Kim, Jung-Gu;Moon, Shin-Yong;Lee, Jin-Yong;Chang, Yoon-Seok
    • Clinical and Experimental Reproductive Medicine
    • /
    • v.18 no.2
    • /
    • pp.201-208
    • /
    • 1991
  • Recently the application of gonadotropin-releasing hormone (GnRH) agonist to superovulation in previous poor responders has resulted in the improved outcomes after in vitro fertilization (IVF) outcome. However, poor responders with poor estradiol $(E_2)$ rise or single dominant follicle are a particularly challenging group. Recent reports have also shown that patients with higher basal serum follicle stimulating hormone (FSH) level, result in poorer ovarian response and lower pregnancy rate. Analysis of the differences of superovulation outcomes according to the different protocols of GnRH agonist, long (L, n = 18) and short (S, n = 16) protocols, in patients with high basal FSH levels (>20mIU/ml) were undertaken at Seoul National University Hospital from June to October 1990. The administration of GnRH agonist was begun on day 21 of the cycle in long protocol, and on day 2 in short protocol. Ages of patients and husbands, basal FSH and luteinizing hormone (LH) levels and FSH/LH ratio did not differ significantly. Types and causes of infertility were evenly distributed. Whereas the duration of stimulation and the amounts of gonadotropins administered were significantly reduced in short protocol, the numbers of oocytes retrieved and cleaved, the cleavage rate and the number of embryos transferred were higher in long protocol without statistical signifieance. The pregnancy rate per ET was 16.7% (2/12) in short protocol, and 17.6% (3/17) in long protocol. These data suggest that both protocols result in the similar superovulation outcomes in patients with higher basal serum FSH levels.

  • PDF

Evaluation of the color reproducibility of all-ceramic restorations fabricated by the digital veneering method

  • Kim, Jae-Hong;Kim, Ki-Baek;Kim, Woong-Chul;Kim, Hae-Young;Kim, Ji-Hwan
    • The Journal of Advanced Prosthodontics
    • /
    • v.6 no.2
    • /
    • pp.71-78
    • /
    • 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.

Effects of immediate and delayed light activation on the polymerization shrinkage-strain of dual-cure resin cements (즉시 광중합과 지연 광중합이 이원 중합 레진시멘트의 중합 수축량에 미치는 영향)

  • Lee, So-Yeoun;Kim, Sung-Hun;Ha, Seung-Ryong;Choi, Yu-Sung;Kim, Hee-Kyung
    • The Journal of Korean Academy of Prosthodontics
    • /
    • v.52 no.3
    • /
    • pp.195-201
    • /
    • 2014
  • Purpose: This study was designed to compare the amount of polymerization shrinkage of dual-cure resin cements according to different polymerization modes and to determine the effect of light activation on the degree of polymerization. Materials and methods: Four kinds of dual-cure resin cements were investigated: Smartcem 2, Panavia F 2.0, Clearfil SA Luting and Zirconite. Each material was tested in three different polymerization modes: self-polymerization only, immediate light polymerization and 5 minutes-delayed light polymerization. The time-dependent polymerization shrinkage-strain was evaluated for 30 minutes by Bonded-disk method at $37^{\circ}C$. Five recordings of each material with three different modes were taken. Data were analyzed using one-way ANOVA and multiple comparison Scheffe′test (${\alpha}$=.05). Results: All materials, except Panavia F 2.0, exhibited the highest polymerization shrinkage-strain through delayed light-activated polymerization. No significant difference between light activation modes was found with Panavia F 2.0. All materials exhibited more than 90% of polymerization rate in the immediate or delayed light activated group within 10 minutes. Conclusion: As a clinical implication of this study, the application of delayed light activation mode to dual-cure resin cements is advantageous in terms of degree of polymerization.

Modification of the TNM Staging System for Stage II/III Gastric Cancer Based on a Prognostic Single Patient Classifier Algorithm

  • Choi, Yoon Young;Jang, Eunji;Seo, Won Jun;Son, Taeil;Kim, Hyoung-Il;Kim, Hyeseon;Hyung, Woo Jin;Huh, Yong-Min;Noh, Sung Hoon;Cheong, Jae-Ho
    • Journal of Gastric Cancer
    • /
    • v.18 no.2
    • /
    • pp.142-151
    • /
    • 2018
  • Purpose: The modification of the cancer classification system aimed to improve the classical anatomy-based tumor, node, metastasis (TNM) staging by considering tumor biology, which is associated with patient prognosis, because such information provides additional precision and flexibility. Materials and Methods: We previously developed an mRNA expression-based single patient classifier (SPC) algorithm that could predict the prognosis of patients with stage II/III gastric cancer. We also validated its utilization in clinical settings. The prognostic single patient classifier (pSPC) differentiates based on 3 prognostic groups (low-, intermediate-, and high-risk), and these groups were considered as independent prognostic factors along with TNM stages. We evaluated whether the modified TNM staging system based on the pSPC has a better prognostic performance than the TNM 8th edition staging system. The data of 652 patients who underwent gastrectomy with curative intent for gastric cancer between 2000 and 2004 were evaluated. Furthermore, 2 other cohorts (n=307 and 625) from a previous study were assessed. Thus, 1,584 patients were included in the analysis. To modify the TNM staging system, one-grade down-staging was applied to low-risk patients according to the pSPC in the TNM 8th edition staging system; for intermediate- and high-risk groups, the modified TNM and TNM 8th edition staging systems were identical. Results: Among the 1,584 patients, 187 (11.8%), 664 (41.9%), and 733 (46.3%) were classified into the low-, intermediate-, and high-risk groups, respectively, according to the pSPC. pSPC prognoses and survival curves of the overall population were well stratified, and the TNM stage-adjusted hazard ratios of the intermediate- and high-risk groups were 1.96 (95% confidence interval [CI], 1.41-2.72; P<0.001) and 2.54 (95% CI, 1.84-3.50; P<0.001), respectively. Using Harrell's C-index, the prognostic performance of the modified TNM system was evaluated, and the results showed that its prognostic performance was better than that of the TNM 8th edition staging system in terms of overall survival (0.635 vs. 0.620, P<0.001). Conclusions: The pSPC-modified TNM staging is an alternative staging system for stage II/III gastric cancer.

Reliability and Validity of the Korean Version of the Post-Traumatic Stress Disorder Checklist in Public Firefighters and Rescue Workers (소방공무원과 구조대원에서 한국어판 Post-Traumatic Stress Disorder Checklist의 신뢰도와 타당도)

  • Park, Shinwon;Jeong, Hyeonseok S.;Im, Jooyeon Jamie;Jeon, Yujin;Ma, Jiyoung;Choi, Yera;Ban, Soonhyun;Kim, Sungeun;Yu, Siyoung;Lee, Sunho;Jeon, Saerom;Kang, Ilhyang;Lee, Bora;Lee, Sooyeon;Son, Jihee;Lim, Jae-ho;Yoon, Sujung;Kim, Eui-Jung;Kim, Jieun E.;Lyoo, In Kyoon
    • Korean Journal of Biological Psychiatry
    • /
    • v.23 no.1
    • /
    • pp.29-36
    • /
    • 2016
  • Objectives Firefighters and rescue workers are likely to be exposed to a variety of traumatic events; as such, they are vulnerable to the risk of post-traumatic stress disorder (PTSD). The psychometric properties of the Korean version of the PTSD Checklist (PCL), a widely used self-report screening tool for PTSD, were assessed in South Korean firefighters and rescue workers. Methods Data were collected via self-report questionnaires and semi-structured clinical interviews administered to 221 firefighters. Internal consistency, item-total correlation, one-week test-retest reliability, convergent validity, and divergent validity were examined. Content validity of the PCL was evaluated using factor analysis and receiver operating characteristic (ROC) analyses were used to estimate the optimal cutoff point and area under the curve. Results The PCL demonstrated excellent internal consistency (${\alpha}=0.97$), item-total correlation (r = 0.72-0.88), test-retest reliability (r = 0.95), and convergent and divergent validity. The total score of PCL was positively correlated with the number of traumatic events experienced (p < 0.001). Factor analysis revealed two theoretically congruent factors: re-experience/avoidance and numbing/hyperarousal. The optimal cutoff was 45 and the area under the ROC curve was 0.97. Conclusions The Korean version of the PCL may be a useful PTSD screening instrument for firefighters and rescue workers, further maximizing opportunities for accurate PTSD diagnosis and treatment.

C-terminal Fusion of EGFP to Pneumolysin from Streptococcus pneumoniae modified its Hemolytic Activity (Streptococcus pneumoniae가 생산하는 pneumolysin의 EGFP 융합으로 인한 용혈활성 변화)

  • Chung, Kyung Tae;Lee, Jae Heon;Jo, Hye Ju
    • Journal of Life Science
    • /
    • v.28 no.1
    • /
    • pp.99-104
    • /
    • 2018
  • Streptococcus pneumoniae is one of the major pathogens in community-acquired diseases, and it contains several factors that promote its pathogenesis, including pneumolysin (PLY). PLY is a member of the cholesterol-dependent cytolysin family, which attacks cholesterol-containing membranes, thereby forming ring-shaped pores. Thus, it is a major key target for vaccines against pneumococcal disease. We cloned the PLY gene from S. pneumoniae D39 and inserted it into the pQE-30 vector. Recombinant PLY (rPLY) was overexpressed in Escherichia coli M15 and purified by $Ni^{2+}$ affinity chromatography. Similarly, a PLY-EGFP fusion gene was produced by inserting the EGFP gene at the 3' end of the PLY gene in the same vector, and the recombinant protein was purified. Sodium dodecyl sulfate - polyacrylamide gel electrophoresis (SDS-PAGE) showed that both recombinant proteins were purified. rPLY exhibited significant hemolytic activity against 1% human red blood cells (RBCs). Complete hemolysis was obtained at 500 ng/ml, and 50% hemolysis was found with a 240 ng/ml concentration. In contrast, rPLY-EGFP did not show hemolytic activity. However, rPLY-EGFP did bind the RBC membrane, indicating that rPLY-EGFP lost hemolytic activity via EGFP fusion, while retaining its membrane-binding ability. These data suggest that PLY's C terminus is important for its hemolytic activity. Therefore, these two recombinant proteins can be extremely useful for investigating the toxin mechanism of PLY and cell damage during pneumonia.

EFFECTS OF RED GINSENG ON PLATELET FUNCTION AND LIPID METABOLISM OR OVERWEIGHTED NONINSULIN-DEPENDENT

  • Choi D.S.;Kim S.J.;Lee E.J.;Yu J.M.;Baik S.H.;Son B.R.;Kim Y.K.
    • Proceedings of the Ginseng society Conference
    • /
    • 1993.09a
    • /
    • pp.102-109
    • /
    • 1993
  • Backgrounds Diabetes mellitus is associated with accelerated atherosc lerosis and predispose to specific microvascular problems. This study was performed to evaluate the usefulness of red ginseng as adjunctive therapeutic agent of NIDDM especially in preventing chronic diabetic complications. Materials and Methods We treated 50 patients with NIDDM for 5 month with 2 regimens: 1)oralhypoglycemic drug therapy only(the control group), 2)oral hypoglycemic group). The patients were recruited at Korea university hospital from June, 1992 to October, 1992 and the following inclusion criteria were used: l)age above 35 years 2)initial body weight within or above ideal body weight 3)fasting blood glucose level greater than 140mg/dl 4)no previous history of diabetes mellitus or no history of blood glucose control for recent 3 months of more. The patients were seen every 2 weeks for remaining 3 months. At every visit FBS and PP2hr blood glucose were measured with blood pressure and body weight. Lipid profiles were checked every 4 weeks and platelet function test was perfomed with aggregometer after administration of ADP, epineprine and collagen every 4 weeks. Free fatty acid were also analyzed every 8 weeks and glycosylated hemoglobin was measured every 12 weeks. Results The results were as follows: 1. The mean values for fasting and PP2hr blood glucose decreased significantly in the control group than in the ginseng group. 2. The weight gain was less in the ginseng group than in the control group. The levels of systolic blood pressure decreased' significantly in the ginseng group than in the control group. 3. There was no significant differences of lipid profiles in both groups. 4. The platelet hyperaggregation was improved more significantly in the ginseng group than in the control group. Conclusions In patients with NIDDM who were recieving oral hypoglycemic drug therapy, the addition of red ginseng improved platelet function and blood pressure, but induced less weight gain. The data suggests that red ginseng may be useful as a therapeutic adjunct especially in preventing chronic complications of NIDDM.

  • PDF