• Title/Summary/Keyword: Crossover study

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Comparison of the Effects of Pilocarpine Solution and Tablet on Salivary Flow Rate

  • Park, Jo-Eun;Song, Chan-Woo;Kim, Ki-Suk;Kim, Mee-Eun
    • Journal of Oral Medicine and Pain
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    • v.40 no.1
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    • pp.10-16
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    • 2015
  • Purpose: Pilocarpine has the effects on improvement of salivary flow and subjective symptoms for xerostomic patients. Because of unwanted side effects following its systemic administration, topical pilocarpine has been paid attention as an alternative. This study aimed to investigate effects of pilocarpine solution as mouthwash on salivary flow and adverse effects compared to systemic administration of 5 mg pilocarpine tablet in healthy subjects. Methods: The study was a double blind, placebo-controlled, crossover clinical trial. Five milligrams pilocarpine tablets, 4 mL of 2% pilocarpine solution and placebo solution were given to 12 healthy volunteers (6 males and 6 females) in a predetermined order with wash-out period of at least two days and unstimulated whole saliva was collected before and after administration of each drug. Blood pressure and pulse rate was also measured and subjective effect and potential side effects were evaluated by a self-administrated questionnaire. Results: Systemic (5 mg tablet) and topical (2% solution) use of pilocarpine significantly increased salivary flow rate in healthy subjects compared to placebo (p<0.001). In both the pilocarpine solution and tablet groups, salivary flow rates at 120 minutes after administration remained increased. Subjective effect on salivation was the largest in the pilocarpine tablet group, followed by the pilocarpine solution group (p<0.05). There was no significant difference in blood pressure and pulse rate after administration of all three drugs. Fewer side effects reported in the pilocarpine solution group than in the tablet group. Conclusions: Two percents pilocarpine solution as mouthwash increases salivary flow rate, definitely superior to placebo solution and comparable to pilocarpine tablet, with fewer side effects in healthy subjects. It indicates a possibility of pilocarpine solution as a useful alternative of pilocarpine tablets for the xerostomic patients with systemic diseases.

Statatistical Analysis of Three Sequence-Three Periods Bioequivalence Study : Application to Bioequivalence Test of Ondansetron Formulations ($3{\times}3$ 라틴 방격법 모델에 따른 생물학적 동등성 시험의 통계 해석 : 온단세트론 제제에 대한 적용 예)

  • Lee, Young-Joo;Lee, Myung-Gull;Chung, Suk-Jae;Lee, Min-Hwa;Shim, Chang-Koo
    • Journal of Pharmaceutical Investigation
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    • v.28 no.1
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    • pp.35-42
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    • 1998
  • A $3{\times}3$ Latin square crossover study for the bioequivalence of three ondansetron formulations was conducted. Test products were $Vominon^{\circledR}$ 8 mg and $Vominon^{\circledR}$ 4 mg tablets and reference product was $Zofran^{\circledR}$ tablet. Twenty one healthy Korean male subjects received each formulation at the ondansetron dose of 8 mg and plasma concentrations of ondansetron were monitored by HPLC for over a period of 12 hr after the oral administration. Statistical procedure for bioequivalence evaluation of AUC {e.g., analysis of variance (ANOVA), multiple comparison and confidence intervals} was carried out. There were no significant differences in AUC among the formulations. The confidence intervals for the AUC of $Vominon^{\circledR}$ 8 mg and $Vominon^{\circledR}$ 4 mg were between -0.24 and 15.54% and between -2.41 and 13.36% respectively, within a range that proposed by the Korea Food and Drug Administration Guidelines for Bioequivalence. These statistical procedure could be standardized and generally applicable for the assessment of bioequivalence for multiple (more than two) formulations.

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A Multi-chambered Single Autoinjector and KMARK-1 Containing Atropine and 2-PAM: Comparative Bioavailability Studies Using Single Intramuscular Injection with Beagle Dogs (아트로핀 및 팜 함유 다중챔버 단일주사기 및 KMARK-1: 비글개를 이용한 단회 근육투여 비교 생체이용률 연구)

  • Lee, Keunwoo;An, Seoyeon;Kwon, Taekeun;Jung, Inhong;Kim, Dongyeon
    • Journal of the Korea Institute of Military Science and Technology
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    • v.20 no.4
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    • pp.587-596
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    • 2017
  • In this study, multi-chambered single autoinjector(2in1) and KMARK-1 containing atropine and 2-PAM(pyridine-2-aldoxime methylchloride) were administered to the beagle's muscle, and blood samples were taken for a certain period of time to compare and evaluate the pharmacokinetic profiles of the two drugs. Male beagles were used and classified into two test groups(G1, G2), and crossover pharmacokinetic studies were performed in two test groups. Blood samples were collected from the jugular vein for analysis after administration. The 90 % confidence interval(CI) for log transformed data indicated that the Cmax for both atropine(log 0.9683 ~ log 1.113) and 2-PAM(log 0.9453 ~ log 1.214) was within the limits of bioequivalence criteria, but the AUC for atropine(log 1.1786 ~ log 1.3238) failed to meet this criteria. This is expected as the amount of atropine dose is 25 % higher for the test as compared to the reference formulation. In summary, in view of the ATNAA(antidote for nerve agent of US) authorization, the Cmax equivalence was more important than AUC equivalence, so in this study, we also focused on verifying the equality of Cmax between the two autoinjectors.

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.

Bioequivalence Evaluation of the Cisapride Formulation Produced by Dong Wha Pharmaceutical Co. (동화약품 시사프리드제제의 생물학적 동등성 평가)

  • 윤광희;박진영;박선주;조은희;유제만;김경식;정석재;이민화;심창구
    • Biomolecules & Therapeutics
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    • v.7 no.1
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    • pp.59-65
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    • 1999
  • A bioequivalence study of the Dong Wha Cisapril tablets(Dong Wha Pharm. Ind. Co., Ltd.) to the Prepulsid tablets(Janssen Korea Ltd.), formulations of cisapride, was conducted. Twenty four healthy Korean male subjects received each formulation at the dose of 5 mg as cisapride in a 2$\times$2 crossover study. There was a 1-week washout period between the doses. Plasma concentrations of cisapride were monitored by an LC/MS method for over a period of 36 h after each administration. AUC(area under the plasma concentration- time curve from time zero to infinity) was calculated by the linear trapezoidal and extrapolation method. $C_{max}$ (maximum plasma drug concentration) and $T_{max}$ (time to reach $C_{max}$) were compiled from the plasma drug concentration-time data. Analysis of variance (ANOVA) revealed that there are no differences in AUC, $C_{max}$ and $T_{max}$ between the formulations. The apparent differences between the formulations in these parameters were all far less than 20% (i.e., 6.8, -6.6 and 1.8% for AUC, $C_{max}$ and $T_{max}$, respectively). Minimum detectable differences(%) at $\alpha$=0.05 and 1-$\beta$=0.8 were all less than 20% in these parameters between the formulations (i.e., 16.5, 11.4 and 16.4% for AUC, $C_{max}$ and $T_{max}$, respectively). The 90% confidence intervals for these parameters were also within 20% (i.e., -2.9~ 16.4, -13.2~0.1 and -7.8~ 11.4% for AUC, $C_{max}$ and $T_{max}$, respectively). These results satisfy the bioequivalence criteria of the Korea Food and Drug Administration (KFDA) guidelines (No. 98-51). Therefore, these results indicate that the two formulations of cisapride are bioequivalent and, thus, may be prescribed interchangeably.hangeably.y.hangeably.

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The research of classical music performance with the techniques borrowed from pop-style arrangements (In rhythm concentrated) (대중음악 편곡 기법을 활용한 클래식곡의 연주에 관한 연구 (리듬섹션을 중심으로))

  • Lee, Tae-Yoon
    • Journal of the Korea Academia-Industrial cooperation Society
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    • v.17 no.9
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    • pp.458-463
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    • 2016
  • New areas can be created by combining separate fields of study. Today, boundaries between fields are collapsing because of rapid progress in technologies, which is also the case in music. In 1969, jazz trumpeter and respected artist Miles Davis combined jazz, rock, and classical music into the fusion genre. Classical music is known to be strict, rigorous, and rigid, and it started to take a different form after experiments with musical crossovers. This study examines the potential of more diverse musical crossovers that musicians use to evolve a new genre. Several musicians in Korea have attempted musical crossovers by following global music trends. In the album, "Love and Peace," the classical music pieces "Flight of the Bumblebee" and Beethoven's "Fate" were arranged using a popular music style.

Free Vibration Analysis of Non-symmetric Thin-Walled Curved Beams with Shear Deformation (전단변형을 고려한 비대칭 박벽 곡선보의 자유진동해석)

  • Kim, Nam-Il;Kim, Moon-Young;Cheol, Min-Byoung
    • Journal of the Earthquake Engineering Society of Korea
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    • v.7 no.4
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    • pp.1-13
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    • 2003
  • For spatial free vibration of non-symmetric thin-walled curved beams with shear deformation, an improved formulation is proposed in the present study. The elastic strain and the kinetic energies are first derived by considering constant curvature and shear deformation effects due to shear forces and restrained warping torsion. Next equilibrium equations and force-deformation relations are obtained using a stationary condition of total potential energy. And the finite element procedures are developed by using isoparametric curved beam element with arbitray thin-walled sections. Particularly not only shear deformation and thickness-curvature effects on vibration behaviors of curved beams but also mode transition and crossover phenomena with change in curvatures of beams are parametrically investigated. In order to illustrate the accuracy and the reliability of this study, various numerical solutions for spatial free vibration are compared with results by available references and ABAQUS's shell element.

Pain perception and efficacy of local analgesia using 2% lignocaine, buffered lignocaine, and 4% articaine in pediatric dental procedures

  • Afsal, M.M;Khatri, Amit;Kalra, Namita;Tyagi, Rishi;Khandelwal, Deepak
    • Journal of Dental Anesthesia and Pain Medicine
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    • v.19 no.2
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    • pp.101-109
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    • 2019
  • Background: The purpose of this study was to compare the pain perception and anesthetic efficacy of 2% lignocaine with 1:200,000 epinephrine, buffered lignocaine, and 4% articaine with 1:200,000 epinephrine for the inferior alveolar nerve block. Methods: This was a double-blind crossover study involving 48 children aged 5-10 years, who received three inferior alveolar nerve block injections in three appointments scheduled one week apart from the next. Pain on injection was assessed using the Wong-Baker Faces pain scale and the sound eye motor scale (SEM). Efficacy of anesthesia was assessed by subjective (tingling or numbness of the lip, tongue, and corner of mouth) and objective signs (pain on probing). Results: Pain perception on injection assessed with Wong-Baker scale was significantly different between buffered lignocaine and lignocaine (P < 0.001) and between buffered lignocaine and articaine (P = 0.041). The onset of anesthesia was lowest for buffered lignocaine, with a statistically significant difference between buffered lignocaine and lignocaine (P < 0.001). Moreover, the efficacy of local analgesia assessed using objective signs was significantly different between buffered lignocaine and lignocaine (P < 0.001) and between lignocaine and articaine. Conclusion: Buffered lignocaine was the least painful and the most efficacious anesthetic agent during the inferior alveolar nerve block injection in 5-10-year-old patients.

Comparison of tracheal intubation using the Miller blade versus Macintosh blade in difficult airway: A manikin study among novice intern doctors (기도확보가 어려운 상황에서 Miller blade와 Macintosh blade를 이용한 기관내삽관의 비교 : 숙련되지 않은 인턴을 대상으로 한 마네킨 연구)

  • Lee, Mi-Lim;Kim, Chul-Tae;Lee, Hyo-Cheol
    • The Korean Journal of Emergency Medical Services
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    • v.22 no.3
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    • pp.35-45
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    • 2018
  • Purpose: The purpose of this study was to compare laryngoscopic views and ease of use and success of intubation, via the percentage of glottic opening (POGO) scale when using the Miller blade and Macintosh blade in paraglossal approach. Methods: Forty intern doctors were randomized for laryngoscopy to be performed in a crossover manner. They performed endotracheal intubation with Miller blade and Macintosh blade in two airway scenarios: normal airway and difficult airway with edema. We observed the rate of successful intubation, time required for visualizing the glottis, time to complete endotracheal intubation, ease of intubation, and the POGO scale. Results: In the normal airway, there was no difference in intubation between the two endoscopes. In the difficult airway, the time for visualizing the glottis (7.80 versus 10.24 sec; p=.006), the time to tube passage (19.38 versus 23.03 sec; p=.038) and the time to complete endotracheal intubation (21.84 versus 28.54 sec; p=.022) with Miller blade was shorter than with Macintosh blade. The POGO scale(%) of the Miller blade was higher than that of the Macintosh blade's (62.25 versus 56.32; p=.030). Conclusion: Compared to the Macintosh blade, Miller blade provided better visualization of the glottis and POGO scale, and faster time to completion of endotracheal intubation.

Users' Preference and Acceptance of Smart Home Technologies (사용자의 스마트 주거 기술 선호와 수용에 관한 연구)

  • Cho, Myung Eun;Kim, Mi Jeong
    • Journal of the Architectural Institute of Korea Planning & Design
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    • v.34 no.11
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    • pp.75-84
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    • 2018
  • This study analyzed users' acceptance and intention to use in addition to needs and preferences of smart home technologies, and identified the differences in technology preference and acceptance by different factors. The subjects were residents in the 40s and 60s residing in the Seoul or suburbs of Seoul, and questionnaires were conducted in the 40s while interviews with questionnaires were conducted in the 60s. A total of 105 questionnaires were used as data, and frequency, mean, crossover, independent sample t test, one-way ANOVA and multiple regression analysis were performaed using SPSS23. The results of this study are as follows. First, hypertension, hyperlipidemia and hypercholesterolemia were the most common diseases among respondents and if there was no discomfort, they would like to continue living in the homes of the current residence. Therefore, the direction of smart home development should support the daily living and health care so that residents can live a healthy life for a long time in their living space. Second, the technologies that residents most need were a control technology of residential environments and a monitoring technology of residents' health and physiological changes. The most preferred sensor types are motion sensors and speech recognition while video cameras have a very low preference. Third, technology anxiety was the most significant factor influencing intention to accept smart home technology. The greater the technology anxiety is, the weaker the acceptance of technology. Fourth, when applying smart residential technology in homes, various resident characteristics should be considered. Age and technology intimacy were the most influential variables, and accordingly there were differences in technology preference and acceptance. Therefore, a user-friendly smart home plan should be done in the consideration of the results.