• Title/Summary/Keyword: clinical equivalence

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Comparison Study about Surface Mapping of Motor Points in Biceps Brachii Muscle Using Surface EMG and Electric Probe (표면 근전도와 전기 탐침기를 이용한 상완이두근의 운동점 표지 비교 연구)

  • Park, Jaewon;Keum, Dongho
    • Journal of Korean Medicine Rehabilitation
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    • v.28 no.1
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    • pp.85-96
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    • 2018
  • Objectives This study was performed to compare the electrical methods of motor points mapping using surface EMG and electric probe (Pointer Excel II). Methods 32 healthy adults (male 16, female 16) were selected. and classified into two groups; surface EMG group, electric probe (Pointer Excel II) group. In surface EMG group, motor points were searched by recoding the compound muscle potentials. In electric probe (Pointer Excel II) group, motor points were searched by scanning the skin with Pointer Excel II at low level stimulation. The locations of the motor points were expressed as X and Y values in relation to the reference line. The horizontal reference line was set as elbow crease and the vertical reference line was set as the line connecting coracoid process to the center of the horizontal reference line. The data was analyzed by 'Independent T-test' and 'equivalence test'. Results 1. The motor points of short head and long head of biceps brachii muscle were located at about 2/3 length of the vertical reference line from coracoid process and about 1/5~1/4 length of the half of the horizontal reference line from the vertical reference line in both group. 2. The motor points of the short head were located more distally and close to the vertical reference line (p<0.001). 3. In surface EMG group, the motor points of the long head were located more laterally in the female than male. And the motor points of the long head were located more distally in the left side than right side (p<0.05). In electric probe (Pointer Excel II) group, similar tendency was observed but there was no statistically significant difference (p>0.05). 4. As a result of the equivalence test between surface EMG group and electric probe (Pointer Excel II) group, the confidence intervals of the difference were within the equivalence limit. Therefore, the locations of the motor points searched by two ways are equa l (p>0.05, equivalence interval=3%). Conclusions The results indicate that electric probe (Pointer Excel II) can be used to search the motor points instead of surface EMG. This might improve the clinical efficiency when using the motor points to treat muscle dysfunction.

Treatment of Latent Tuberculosis Infection and Its Clinical Efficacy

  • Kim, Hyung Woo;Kim, Ju Sang
    • Tuberculosis and Respiratory Diseases
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    • v.81 no.1
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    • pp.6-12
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    • 2018
  • The role of the treatment for latent tuberculosis infection (LTBI) has been underscored in the intermediate tuberculosis (TB) burden countries like South Korea. LTBI treatment is recommended only for patients at risk for progression to active TB-those with frequent exposure to active TB cases, and those with clinical risk factors (e.g., immunocompromised patients). Recently revised National Institute for Health and Care Excellence (NICE) guideline recommended that close contacts of individuals with active pulmonary or laryngeal TB, aged between 18 and 65 years, should undergo LTBI treatment. Various regimens for LTBI treatment were recommended in NICE, World Health Organization (WHO), and Centers for Disease Control and Prevention guidelines, and superiority of one recommended regimen over another was not yet established. Traditional 6 to 9 months of isoniazid (6H or 9H) regimen has an advantage of the most abundant evidence for clinical efficacy-60%-90% of estimated protective effect. However, 6H or 9H regimen is related with hepatotoxicity and low compliance. Four months of rifampin regimen is characterized by less hepatotoxicity and better compliance than 9H, but has few evidence of clinical efficacy. Three months of isoniazid plus rifampin was proved equivalence with 6H or 9H regimen in terms of efficacy and safety, which was recommended in NICE and WHO guidelines. The clinical efficacy of isoniazid plus rifapentine once-weekly regimen for 3 months was demonstrated recently, which is not yet introduced into South Korea.

Acoustic outputs from clinical extracorporeal shock wave lithotripsy devices (임상에서 사용중인 체외충격파쇄석기의 음향 출력 분포)

  • Jong Min Kim;Oh Bin Kwon;Jin Sik Cho;Sung Joung Jeon;Ki Il Nam;Sung Yong Cho;Min Joo Choi
    • The Journal of the Acoustical Society of Korea
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    • v.42 no.5
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    • pp.469-490
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    • 2023
  • Survey was carried out on the acoustic outputs from 12 shock wave fields produced by the 10 extracorporeal shock wave lithotriptors whose technical documents are available, among the 33 devices approved by the Ministry of Food & Drug Safety (MFDS).The results show that the acoustic outputs (P+, P-, efd, and E), critical to the therapeutic efficacy and the patient safety, are largely different between the devices. The maximum values of P+, P-, efd, and E vary up to 2.08, 3.72, 3.89, and 15.98 times, respectively. The acoustic output parameters are not thoroughly provided in the technical documents, and some of data (eg. efd) are suspected to be abnormal outside usual ranges. The large device to device differences in the shock wave outputs are likely to undermine equivalence between the ESWL devices approved for the same indication. To verify the reliability of the data in the technical documents of the approved devices and to confirm if the acoustic outputs from the devices in clinical use are the same as those in their technical documents, an authorized test laboratory should be available. A postapproval monitoring led by the regulatory agency is suggested to maintain the acoustic outputs from the ESWL devices that suffer from degrading in performance due to aging.

Peri-implant disease: what we know and what we need to know

  • Valente, Nicola Alberto;Andreana, Sebastiano
    • Journal of Periodontal and Implant Science
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    • v.46 no.3
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    • pp.136-151
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    • 2016
  • Peri-implant disease is a serious problem that plagues today's dentistry, both in terms of therapy and epidemiology. With the expansion of the practice of implantology and an increasing number of implants placed annually, the frequency of peri-implant disease has greatly expanded. Its clinical manifestations, in the absence of a globally established classification, are peri-implant mucositis and peri-implantitis, the counterparts of gingivitis and periodontitis, respectively. However, many doubts remain about its features. Official diagnostic criteria, globally recognized by the dental community, have not yet been introduced. The latest studies using metagenomic methods are casting doubt on the assumption of microbial equivalence between periodontal and peri-implant crevices. Research on most of the features of peri-implant disease remains at an early stage; moreover, there is not a commonly accepted treatment for it. In any case, although the evidence so far collected is limited, we need to be aware of the current state of the science regarding this topic to better understand and ultimately prevent this disease.

Studies on the Bioequivalence Test of Isoniazid Tablets (시판 이소니아짓 정제의 생물학적 동등성시험에 관한 연구)

  • Choi, Jun-Shik;An, Seon-Yeob
    • YAKHAK HOEJI
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    • v.33 no.4
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    • pp.229-236
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    • 1989
  • Even though two different preparations are chemically equivalent, the variance of bioavailability differenciates the clinical effect of preparations, so that the preparations need to be evaluated by comparing bioavailability in vivo as well as chemical equivalence. In this study, bioequivalence tests of commercially available isoniazid tablets A, B, C and D (standard) were performed to give some guidelines to bioequivalence test. The bioavailability parameters obtained by drug administeration were statistically analyzed. Statistical evaluation of the data involved an analysis of variance for a cross over design. Cross over design was employed with 8 healthy volunteers. The results were within 20% difference of mean value in the AUC, Cmax, Tmax and amount of urinary excretion (Au) between standard and isoniazid tablets. The results of ANOVA showed no significant differences for 'group or sequence', but almost not for 'between subjects'. The tablet. A, B and D were within 20 min, but tablet C was within 50 min. Tablet A was biologically equivalent in the Au. tablet B biologically equivalent in the Au and AUC. Tablet C was biologically equivalent in the Au. The relationship between the dissolution rate and Au was significant.

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Semantic Network Analysis about Comments on Internet Articles about Nurse Workplace Bullying (간호사 괴롭힘 관련 인터넷 포털 기사에 대한 댓글의 의미연결망 분석)

  • Kim, Chang Hee;Moon, Seong Mi
    • Journal of Korean Clinical Nursing Research
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    • v.25 no.3
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    • pp.209-220
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    • 2019
  • Purpose: A significant amount of public opinion about nurse bullying is expressed on the internet. The purpose of this study was to analyze the linkage structures among words extracted from comments on internet articles related to nurse workplace bullying using semantic network analysis. Methods: From February 2018 to April 2019, comments made on news articles posted to the Daum and Naver web portal containing keywords such as "nurse", "Taeum", and "bullying" were collected using a web crawler written in Python. A morphological analysis performed with Open Korean Text in KoNLPy generated 54 major nodes. The frequencies, eigenvector centralities, and betweenness centralities of the 54 nodes were calculated and semantic networks were visualized using the UCINET and NetDraw programs. Convergence of iterated correlations (CONCOR) analysis was performed to identify structural equivalence. Results: This paper presents results about March 2018 and January 2019 because these months had highest number of articles. Of the 54 major nodes, "nurse", "hospital", "patient", and "physician" were the most frequent and had the highest eigenvector and betweenness centralities. The CONCOR analysis identified work environment, nurse, gender, and military clusters. Conclusion: This study structurally explored public opinion about nurse bullying through semantic network analysis. It is suggested that various studies on nursing phenomena will be conducted using social network analysis.

Bioequivalence of Cefaclor Capsules Following Single Dose Administration to Healthy Male Volunteers (세파클러 캅셀제에 대한 생물학적 동등성 평가)

  • Bok, Hae Sook;Kim, Myoung Min;Kwon, Yi Oh;Choi, Kyung Eob
    • Korean Journal of Clinical Pharmacy
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    • v.7 no.1
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    • pp.17-21
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    • 1997
  • Cefaclor is a second generation cephalosporin antibiotic that shows a potent antibacterial activity against both Gram-positive and Gram-negative bacteria, when it is orally administered. Due to its patent expiration, a number of generic drugs have been marketed, but not yet elucidated to ensure therapeutic equivalence. In this study, cefaclor capsules manufactured by Chong Kun Dang were bioequivallently assessed by comparing with $Ceclor^{TM}$ introduced originally by Daewoong Lilly. A total of 16 healthy male volunteers were evaluated in a randomized crossover manner with a 2-week washout period. Concentrations of cefaclor in plasma were measured upto 6 hours following a single oral administration of two capsules (500 mg of cefaclor) by high-performance liquid chromatography with UV detection. Although the plasma concentration at 6 hours was not detected, the computed half-life of cefaclor was approximately 0.5 hours. The area under the concentration-vs-time curve from 0 to 4 hours $(AUC_{0-4h})$ was calculated by the trapezoidal summation method. The differences in mean values of $AUC_{0-4h}$, peak plasma concentration $(C_{max})$, and time to peak concentration $(T_{max})$ between the two products were $4.63\%,\;1.84\%,\;and\3.28\%$, respectively. The least significant differences at $\alpha4= 0.05 for $AUC_{0-4h},\;C_{max},\;and\;T_{max}\;were\;6,53\%,\;4.05\%,\;and\;6.47\%$, respectively. In conclusion, the test drug was bioequivalent with the reference drug.

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Utilization of Sunitinib for Renal Cell Cancer: an Egyptian University hospital experience

  • Ezz El Din, M
    • Asian Pacific Journal of Cancer Prevention
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    • v.17 no.7
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    • pp.3161-3166
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    • 2016
  • Background: Metastatic renal cell carcinoma (mRCC) status as poor prognosis improved with the introduction of tyrosine-kinase inhibitors, especially sunitinib. There is sparse data reporting from our region on use of sunitinib in metastatic RCC. Thus the present study explores sunitinib usage at our institute. Materials and Methods: An unselected population of patients with metastatic RCC receiving sunitinib was analyzed with respect to patient characteristics, response, toxicity, and outcomes. Results: Fourty-nine patients with a median age of 50.5 years (range 21-71 years) were included. Most were male (61.2%). Twenty‑one (42.9%) had metastatic disease at presentation. Sunitinib was first line therapy in 45. Conventional clear cell carcinoma was the most common pathology present (39 patients; 79.59 %). The most common site of metastasis was the lung (75.5%). Most patients (30) were started at a dose of 50 mg once a day for 4 weeks and then 2 weeks rest. Clinical benefit rate was 73.5% (n= 36), and 22.5% (n= 11) demonstrated progressive disease at first imaging evaluation within the first 3-6 months. The following objective response performed for patients was 48.9% (n=24) and progression at 24.5 % (n=12). The median follow‑up was 16 months (range, 4-34 months), the overall estimated median PFS was 9 months and the estimated median OS was 15 months. Conclusions: This study demonstrated sunitinib is tolerable and effective in advanced/metastatic RCC Egyptian patients and indicates we should further seek second and third lines to increase survival equivalence as reported in the worldwide literature.

Bioequivalence of Commercially available Sustained Release Tablets of Diltiazem Hydrochloride (시판 염산 딜티아젬 서방형 정제의 생물학적 동등성)

  • Lee, Young-Bok;Koh, Ik-Bae;Seo, Se-Min;Yoon, Heong-Tung
    • Korean Journal of Clinical Pharmacy
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    • v.3 no.1
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    • pp.79-88
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    • 1993
  • Bioequivalence(BE) test of commercially available sustained release tablets of diltiazem hydrochloride(DTZ) was performed to give some guidelines to BE test in korea in case of which drugs with low oral bioavaiiability(BA) due to substantial first-pass hepatic loss form pharmacologically active metabolites. In such cases, the pharmacologic activity after oral administration is greater than anticipated from BA data, based on chemical assay of drug alone. Therefore, this paper explores the use and meaning of area under the plasma concentration-time(AUC) data of parent and its metabolites to access BA if sustained release tablets. Normal healthy male volunteers(n=14) were randomly divided into 2 groups, and sustained release reference$(Herbesser^{(R)})$ and test$(Herben^{(R)})$ tablets of DTZ-30mg were given orally by balanced two-period cross-over dosing schedule. The plasma concentration of DTZ and and its active metabolite, desacetyldiitiazem(DAD), were determined by high performance liquid chromatography, and, $AUC_{DTZ},\;AUC_{DAD},\;AUC_{DTZ+DAD},\;C_{max}\;and\;T_{max}$ obtained. Analysis of varlance(ANOVA) showed that $AUC_{DTZ}\;and\;C_{max}$ passed the standard $(\alpha=0.05,\;1-\beta\geq0.8,\;\Delta\leq0.2)$ of BE test of korea, but $AUC_{DAD}$ was not satisfied from the standpoint of power. On the other hand, $AUC_{DTZ\midDAD}$ may be more avaliable than $AUC_{DAD}$ from the standpoint of statistics and pharmacologic equivalence.

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Bio-Equivalence Analysis using Linear Mixed Model (선형혼합모형을 활용한 생물학적 동등성 분석)

  • An, Hyungmi;Lee, Youngjo;Yu, Kyung-Sang
    • The Korean Journal of Applied Statistics
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    • v.28 no.2
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    • pp.289-294
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    • 2015
  • Linear mixed models are commonly used in the clinical pharmaceutical studies to analyze repeated measures such as the crossover study data of bioequivalence studies. In these models, random effects describe the correlation between repeated outcomes and variance-covariance matrix explain within-subject variabilities. Bioequivalence analysis verifies whether a 90% confidence interval for geometric mean ratio of Cmax and AUC between reference drug and test drug is included in the bioequivalence margin [0.8, 1.25] performed using linear mixed models with period, sequence and treatment effects as fixed and sequence nested subject effects as random. A Levofloxacin study is referred to for an example of real data analysis.