• 제목/요약/키워드: Bridging study

검색결과 454건 처리시간 0.028초

BIOEQUIVALENCE EVALUATION OF FLUCONAZOLE 50 MG THREE CAPSULES IN HEALTHY MALE KOREAN VOLUNTEERS

  • Kang, Hyun-Ah;Baek, Seung-Hee;Kim, Eun-Hee;Lee, Yong-Bok
    • 대한약학회:학술대회논문집
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    • 대한약학회 2003년도 Proceedings of the Convention of the Pharmaceutical Society of Korea Vol.1
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    • pp.311.2-312
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    • 2003
  • The purposes of this study were to evaluate bioequivalence (BE) using In-transformed pharmacokinetic parameters obtained from two fluconazole products and to develop the analytical methods for the quantitative determination of fluconazole in human serum. In addition, the in vitro dissolution profiles of the two fluconazole products at dissolution media: 0.1 M hydrochloride (KP Ⅶ Apparatus II method) were assessed. (omitted)

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POPULATION PHARMACOKINETICS OF TERBINAFINE IN HEALTHY MALE KOREAN SUBJECTS USING NONMEM

  • Kang, Hyun-Ah;Cho, Hea-Youg;Lee, Suk;Lee, Yong-Bok
    • 대한약학회:학술대회논문집
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    • 대한약학회 2002년도 Proceedings of the Convention of the Pharmaceutical Society of Korea Vol.2
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    • pp.421.1-421.1
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    • 2002
  • The purposes of this study were to evaluate the population pharmacokinetics of terbinafine according to two-compartment model will, lag time and to investigate the influence of characteristics or subjects such as body weight and age on the pharmacokinetic parameters of terbinatine. Serum data from 73 healthy male Korean subjects were used for this analysis. After overnight fast. each subject received a single 125 mg oral dose of terbinafine. (omitted)

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SiC 휘스커 보강 알루미나 복합재료에서 Slow Crack Growth 현상의 직접관찰 연구 (In Situ Observation of Slow Crack Growth in a Whisker-Reinforced Alumina Matrix Composite)

  • 손기선;김우상;이성학
    • 한국세라믹학회지
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    • 제33권2호
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    • pp.203-213
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    • 1996
  • In this study the subcritical crack growth behavior in an Al2O3-SiCw composite has been investigated using in situ fracture technique of applied moment double cantilever beam (AMDCB) specimens indside an SEM. This technique allows the detailed observation of whisker and grain bridging in the crack wake region. The experimental results indicated that the KI-a curve was deviated from the conventional powder law form and that the existed a region where the rate of microcrack growth was decreased with increasing the externally applied stress intensity factor. This behavior could be explained by arising crack growth resistance i.e. R-curve behavior which was associated with crack shielding due to whisker and grain bridging. The R-curve was also analyzed from the KI-a curve data in order to quantify the bridging effect in the Al2O3-SiCw composite.

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타이레놀이알서방정(아세트아미노핀 650 mg)에 대한 타이리콜이알정의 생물학적동등성 (Bioequivalence of Tylicol ER Tablet to Tylenol® ER Tablet (Acetaminophen 650 mg))

  • 강현아;김동호;박선애;윤화;김경란;박은자;조혜영;이용복
    • Journal of Pharmaceutical Investigation
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    • 제36권3호
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    • pp.201-207
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    • 2006
  • Acetaminophen (paracetamol), a para-aminophenol derivative, has analgesic and antipyretic properties and weak anti-inflammatory activity. The purpose of the present study was to evaluate the bioequivalence of two acetaminophen tablets, $Tylenol^{\circledR}$ ER (Janssen Korea Ltd.) and Tylicol ER (Hana Pharmaceutical Co., Ltd.), according to the guidelines of the Korea Food and Drug Administration (KFDA). The release of acetaminophen from the two acetaminophen formulations in vitro was tested using KP VIll Apparatus II method with pH 1.2 buffer solution. Twenty six healthy male subjects, $22.8{\pm}1.99$ years in age and $65.6{\pm}8.03$ kg in body weight, were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After a single tablet containing 650 mg as acetaminophen was orally administered, blood samples were taken at predetermined time intervals and the concentrations of acetaminophen in serum were determined using HPLC with UV detector. The dissolution profiles of two formulations were similar in pH 1.2 buffer solution. The pharmacokinetic parameters such as $AUC_t$, $C_{max}$ and $T_{max}$ were calculated and ANOVA test was utilized for the statistical analysis of the parameters using logarithmically transformed $AUC_t$, $C_{max}$ and untransformed $T_{max}$. The results showed that the differences between two formulations based on the reference drug, $Tylenol^{\circledR}$ ER, were 2.84, 1.89 and -1.36% 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 log 0.8 to log 1.25 (e.g., log $0.987{\sim}log$ 1.08 and log $0.944{\sim}log$ 1.17 for $AUC_t$ and $C_{max}$, respectively). Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating Tylicol ER tablet was bioequivalent to $Tylenol^{\circledR}$ ER tablet.

비유피-4 정(염산프로피베린 20 mg)에 대한 건일염산프로피베린 정의 생물학적동등성 (Bioequivalence of Kuhnil Propiverine Hydrochloride Tablet to BUP-4 Tablet (Propiverine Hydrochloride 20 mg))

  • 조혜영;박은자;강현아;백승희;김세미;박찬호;오인준;문재동;이용복
    • Journal of Pharmaceutical Investigation
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    • 제34권5호
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    • pp.419-425
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    • 2004
  • The purpose of the present study was to evaluate the bioequivalence of two propiverine hydrochloride tablets, BUP-4 (Jeil Pharm. Co., Ltd.) and Kuhnil Propiverine Hydrochloride (Kuhnil Pharm. Co., Ltd.), according to the guidelines of the Korea Food and Drug Administration (KFDA). The propiverine release from the two propiverine hydrochloride formulations in vitro was tested using KP VIII Apparatus II method with a variety of dissolution media (pH 1.2, 4.0, 6.8 buffer solutions, water and blend of polysorbate 80 into pH 6.8). Twenty six healthy male subjects, $23.73{\pm}2.79$ years in age and $67.04{\pm}7.93\;kg$ in body weight, were divided into two groups and a randomized $2\;{\times}\;2$ cross-over study was employed. After one tablet containing 20 mg as propiverine hydrochloride was orally administered, blood was taken at predetermined time intervals and the concentrations of propiverine in serum were determined using HPLC method with UV detector. The dissolution profiles of two formulations were similar at all dissolution media. Besides, the pharmacokinetic parameters such as $AUC_t,\;C_{max}\;and\;T_{max}$ were calculated and ANOVA test was utilized for the statistical analysis of the parameters using logarithmically transformed $AUC_t,\;C_{max}$ and untransformed $T_{max}$. The results showed that the differences between two formulations based on the BUP-4 were 0.17%, 7.98% and 4.55% 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 log(0.8) to log(1.25) $(e.g.,\;log(0.88){\sim}log(1.l2)\;and\;log(0.90){\sim}log(1.l5)\;for\;AUC_t\;and\;C_{max},\;respectively)$. Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating Kuhnil Propiverine Hydrochloride tablet was bioequivalent to BUP-4 tablet.

Bioequivalence of Boryung Torsemide Tablet to Torem Tablet (Torasemide 10 mg) by High Performance Liquid Chromatography/UV Detector

  • Cho, Hea-Young;Kang, Hyun-Ah;Park, Chan-Ho;Kim, Se-Mi;Kim, Dong-Ho;Park, Sun-Ae;Kim, Kyung-Ran;Hur, Hyeon;Lee, Yong-Bok
    • Journal of Pharmaceutical Investigation
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    • 제35권5호
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    • pp.323-328
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    • 2005
  • The purpose of the present study was to evaluate the bioequivalence of two torasemide tablets, Torem tablet (Roche Korea Co., Ltd., Korea, reference drug) and Boryung Torsemide tablet (Boryung Pharmaceutical Co., Ltd., Korea, test drug), according to the guidelines of Korea Food and Drug Administration (KFDA). After adding an internal standard (furosemide) to human serum, serum samples were extracted using 5 mL of ethyl acetate. Compounds were analyzed by reverse-phase HPLC method with UV detection. This method showed linear response over the concentration range of 0.05 ug/mL with correlation coefficient of 0.999. The lower limit of quantitation using 0.5 mL of serum was 0.05 ug/mL which was sensitive enough for pharmacokinetic studies. Twenty-eight healthy male Korean volunteers received each medicine at the torasemide dose of 20 mg in a $2{\times}2$ crossover study. There was a one-week washout period between the doses. Serum concentrations of torasemide were monitored by an HPLC-UV for over a period of 12 hr after the administration. $AUC_{t}$(the area under the serum concentration-time curve from time zero to 12 hr) was calculated by the linear trapezoidal rule method. $C_{max}$ (maximum serum drug concentration) and $T_{max}$ (time to reach $C_{max}$) were compiled from the serum concentration-time data. Analysis of variance was carried out using logarithmically transformed $AUC_{t}$ and $C_{max}$. No significant sequence effect was found for all of the bioavailability parameters indicating that the crossover design was properly performed. The 90% confidence intervals of the $AUC_{t}$ ratio and the $C_{max}$ ratio for Boryung Torsemide/Torem were log 0.97-10g 1.03 and log 0.93log 1.12, respectively. These values were within the acceptable bioequivalence intervals of log 0.80-log 1.25. Thus, the criteria of the KFDA guidelines for the bioequivalence was satisfied, indicating Boryung Torsemide tablet and Torem tablet are bioequivalent.

교각운동에서 다리의 위치에 따른 목폄근의 활성도에 미치는 영향 (Effects of the Trunk and Neck Extensor Muscle Activity According to Leg Positionon in Bridging Exercise)

  • 조현래;정다은;채정병
    • 대한물리의학회지
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    • 제9권1호
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    • pp.125-132
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    • 2014
  • PURPOSE: This study aims to determine the optimal knee joint angle and hip joint angle for minimizing the cervical muscle tension and maximizing the muscle activity of the trunk during the bridging exercise for trunk stabilization. METHODS: The bridging exercise in this study included seven forms of exercise: having a knee joint flexion angle of $120^{\circ}$, $90^{\circ}$, $60^{\circ}$, $45^{\circ}$ and hip joint abduction angle of $15^{\circ}$, $10^{\circ}$, $5^{\circ}$. The posture of the bridging exercise was as follows. To prevent the increase of hyper lumbar lordosis during the bridging exercise, the exercise was practiced after maintaining the lumbar neutral position through the pelvic posterior tilting exercise. RESULTS: The abduction angles did not result in statistically significant effects on the cervical erector, external oblique, rectus abdominis and erector spinae muscles. However, in relation to the knee joint angles, during the bridging exercise, statistically significant results were exhibited. CONCLUSION: The knee joint angle affected the muscle activity of the neck muscle. The greater the knee joint angle, the lower the load placed on the neck muscle. In contrast, the load increased as the knee joint angle decreased. In addition, the muscle activity of the neck muscle and trunk muscle increased as the knee joint angle decreased.

슬관절 각도에 따른 교각운동이 체간근 활성도에 미치는 영향 (The Effect of Trunk Muscle Activity on Bridging Exercise According to the Knee Joint Angle)

  • 김경환;박래준;장준혁;이우형;기경일
    • 대한물리의학회지
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    • 제5권3호
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    • pp.405-412
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    • 2010
  • Purpose : The purpose of this study was to assess the effects of the trunk muscle activity on bridging exercise according to the knee joint angle. Methods : Twenty-five healthy adults volunteered to participate in this study. Subjects were required to complete following four bridging exercises; knee joint flexion $120^{\circ}$, $90^{\circ}$, $60^{\circ}$, $45^{\circ}$. Surface electromyography from selected trunk muscles was normalized to maximum voluntary isometric contraction. Muscle activity was measured by QEMG-4 system(LXM 3204, Laxtha Korea). A repeated measures of one-way ANOVA with post-hoc Bonferroni's correction was used to determine the influence of bridging exercise on muscle activity for each muscle and descriptive statistics was used to determine local/global muscle ratio. Results : The internal oblique of bridging exercises $120^{\circ}$, $90^{\circ}$ showed significantly(p<.05). The erctor spinae of all bridging exercises showed significant excepted between $60^{\circ}$ and $45^{\circ}$(p<.05). Median of internal oblique/rectus abdominis ratio of $120^{\circ}$ was 4.41, $90^{\circ}$ was 3.94, $60^{\circ}$ was 3.58, $45^{\circ}$ was 3.39. Median of internal oblique/external oblique ratio of $120^{\circ}$ was 2.66, $90^{\circ}$ was 2.43, $60^{\circ}$ was 2.87, $45^{\circ}$ was 2.64. Conclusion : Angular motion decreasing with knee joint flexion made erector spinae activation increase. on the other hand, as decreasing abdomen muscle activation, the more performing motor learning is required for abdomen muscle strength and co-contraction for the trunk stabilization.

교각 자세 운동 시 지지면 불안정성을 통한 과제 난이도가 다열근의 선택적 근활성도 비에 미치는 영향 (The Effects of Task Difficulty Controlled by Surface Condition During Bridging Exercise on Relative Multifidus Activation Ratio)

  • 송은주;최종덕
    • 한국전문물리치료학회지
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    • 제18권3호
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    • pp.59-66
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    • 2011
  • The purpose of this study is to examine the activity ratios of global trunk muscles and local trunk muscles in relation to adjustments in the level of task difficulty while performing stability exercises in easily applied bridging lumbar stabilization exercise. Twenty healthy subjects performed bridging lumbar stabilization exercise while the level of task difficulty was plate was used in the same posture for all the exercises. EMG was used to examine the activity ratios of the global muscles and multifidus in relation to the level of task difficulty. Moreover, the activity ratios of the multifidus muscle, the erector spinae and the gluteus maximus muscle were measured. A one-way ANOVA with repeated measures was used, and a Bonferroni correction was conducted (${\alpha}$=.05). When the bridging lumbar stabilization exercise were performed at different difficulty levels, the activity of the multifidus muscle, which is a local muscle, was high in all three exercises. Also, compared to low intensity and intermediate intensity exercises, high intensity exercises showed more significant differences (${\alpha}$=.05). Among all the muscles, the multifidus showed the highest activity at intermediate intensity. Based on these results, we suggest that in the case of bridging lumbar stabilization exercise, low intensity or intermediate intensity exercises are more suitable and efficient for local muscle stabilization.

The Fatigue Behavior and Delamination Properties in Fiber Reinforced Aramid Laminates -Case (I) : AFRP/Al Laminates-

  • Song, Sam-Hong;Kim, Cheol-Woong
    • Journal of Mechanical Science and Technology
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    • 제17권3호
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    • pp.343-349
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    • 2003
  • The fuselage-wing intersection suffers from the cyclic bending moment of variable amplitude. Therefore, the influence of cyclic bending moment on the delamination and the fatigue crack propagation behavior in AFRP/Al laminate of fuselage-wing was investigated in this study. The cyclic bending moment fatigue test in AFRP/Al laminate was performed with five levels of bending moment. The shape and size of the delamination Lone formed along the fatigue crack between aluminum sheet and aramid fiber-adhesive layer were measured by an ultrasonic C-scan. The relationships between da/dN and ΔK, between the cyclic bending moment and the delamination zone size, and between the fiber bridging behavior and the delamination zone were studied. As results, fiber failures were not observed in the delamination zone in this study, the fiber bridging modification factor increases and the fatigue crack growth rate decrease and the shape of delamination zone is semi-elliptic with the contour decreasing non-linearly toward the crack tip.