• Journal of Pharmaceutical Investigation
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• 제41권3호
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• pp.191-196
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• 2011

In this study simple and sensitive high performance liquid chromatographic method using a commercially available column, was developed and validated for the determination of zolpidem tartrate in human plasma. The developed method with suitable validation was applied to a bioequivalence study of two different kinds of zolpidem tartrate. Two different formulations containing 10 mg of zolpidem tartate (CAS : 99294-93-6) were compared in 24 healthy male volunteers in order to compare the bioavailability and prove the bioequivalence. The study was performed in an open, single dose randomized, 2-sequence, cross-over design in 24 healthy male volunteers with a one-week washout period. Blood samples for pharmacokinetic profiling were drawn at selected times during 12 h. The mean $AUC_{0-12h}$, $C_{max}$, $T_{max}$ and $T_{1/2}$ were $676.6{\pm}223.4$ $ng{\cdot}h{\cdot}mL^{-1}$, $177.4{\pm}34.2$ $ng{\cdot}mL^{-1}$, and $0.8{\pm}0.4$ and $3.5{\pm}2.1$, respectively, for the test formulations, and $640.7{\pm}186.6$ $ng{\cdot}h{\cdot}mL^{-1}$, $193.0{\pm}64.5$ $ng{\cdot}mL^{-1}$, and $0.9{\pm}0.4$ and $2.7{\pm}0.9$, respectively, for the reference formulation. Both primary target parameters $AUC_{0-12h}$ and $C_{max}$ were log-transformed and tested parametrically by analysis of variance (ANOVA). 90% confidence intervals of $AUC_{0-12h}$ and $C_{max}$ were in the range of acceptable limits of bioequivalence (80-125%). Based on these results, the two formulations of zolpidem tartate are considered to be bioequivalent.

• Journal of Dental Anesthesia and Pain Medicine
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• 제20권2호
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• pp.73-81
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• 2020

Background: The international organization for standardization (ISO) 80601-2-61 dictates that the accuracy of a pulse oximeter should be assessed by a controlled desaturation study. We aimed to characterize the relationship between the fraction of inspired oxygen (FiO₂) and peripheral oxygen saturation (SpO₂) using a turnover model by retrospectively analyzing the data obtained from previous controlled desaturation studies. Materials and Methods: Each volunteer was placed in a semi-Fowler's position and connected to a breathing circuit to administer the hypoxic gas mixture containing medical air, oxygen, nitrogen, and carbon dioxide. Volunteers were exposed to various levels of induced hypoxia over 70-100% arterial oxygen saturation (SaO₂). The study period consisted of two rounds of hypoxia and the volunteers were maintained in room air between each round. FiO₂ and SpO₂ were recorded continuously during the study period. A population pharmacodynamic analysis was performed with the NONMEM VII level 4 (ICON Development Solutions, Ellicott City, MD, USA). Results: In total, 2899 SpO₂ data points obtained from 20 volunteers were used to determine the pharmacodynamic characteristics. The pharmacodynamic parameters were as follows: k_out = 0.942 1/min, Imax = 0.802, IC₅₀ = 85.3%, γ = 27.3. Conclusion: The changes in SpO₂ due to decreases in FiO₂ well explained by the turnover model with inhibitory function as a sigmoidal model.

• The Korean Journal of Pain
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• 제19권2호
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• pp.159-163
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• 2006

Background: Despite the enormous amount of basic research on neuropathic pain, there is the lack of an objective diagnostic test for complex regional pain syndrome (CRPS). The aim of this study was to evaluate the usefulness of cold stress thermography in the diagnosis of CRPS. Methods: The study involved 12 patients with CRPS type 1, according to the IASP criteria, who were compared with 15 normal healthy volunteers. All subjects underwent thermographic examination under baseline conditions at $21^{\circ}C$. A cold stress test (CST; $10^{\circ}C$ water for 1 minute) was then applied to both hands below the wrists, immediate, and after 10 and 20 minutes. Results: The temperature asymmetry between the patients with CRPS and the volunteers showed significant discrimination at the baseline and after a 20 minute recovery period from the CST. Among the study subjects having temperature asymmetry of both hands of less than $1^{\circ}C$ (8 out of 12 CRPS patients and 14 out of 15 volunteer), 7 (87.5%) of the 8 CRPS patients and 3 (21%) of the 14 volunteers showed a temperature difference of more than $1^{\circ}C$ after the 20 minute recovery period. The actual temperature values during the four periods did not discriminate between the patients with CRPS and the volunteers. Conclusions: Thermography, under the CST, could be a more objective test for the diagnosis of CRPS. A temperature asymmetry greater than $1^{\circ}C$ during the 20 minute recovery period following CST provides strong diagnostic information about CRPS, with both high sensitivity and specificity.

• Archives of Pharmacal Research
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• 제27권6호
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• pp.676-681
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• 2004

Acetyl-L-camitine (ALC), a naturally occurring endogenous compound, has been shown to improve the cognitive performance of patients with senile dementia Alzheimer＇s type, and to be involved in cholinergic neurotransmission. Because ALC is an endogenous compound, valida-tion of the analytical methods of ALC in the biological fluids is very important and difficult. This study was presented validation and correction for plasma ALC concentrations and pharmacok-inetics after oral administration of ALC to human volunteers. ALC concentrations in human plasma were corrected by subtracting the concentration of blank plasma from each sample. Precision and accuracy (bias %) for uncorrected ALC concentrations were below 2.6 and 6.5% for intra-days, and 4.0 and 9.4% for inter-days, respectively. Precision and accuracy (bias %)for corrected ALC concentrations were below 10.9 and 6.0% for intra-days, and 10.5 and 16.9% for inter-days, respectively. Quantitation limit was $0.1{\;}\mu\textrm{g}／mL$. After oral administration of a 500 mg ALC tablet to 8 healthy volunteers, the principle pharmacokinetic parameters were 4.2 h of the half-life$ (t_{1/2},{\beta})$, the area under the curve $(AUC_{0{\rightarrow}8){\;}of{\;}9.88{\;}\mu\textrm{g}{\cdot}h/mL$, and 3.1 h of the time ($T_{max}$) to reach $C_{max}$. This study first describes the pharmacokinetic study after oral admin-istration of a single dose of ALC in human volunteers.

• Korean Journal of Radiology
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• 제23권2호
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• pp.218-225
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• 2022

Objective: This study aimed to explore the feasibility of functional evaluation of the lateral pterygoid muscle (LPM) using diffusion tensor imaging (DTI) in patients with temporomandibular joint disorders (TMDs). Materials and Methods: A total of 119 patients with TMD (23 male and 96 female; mean age ± standard deviation, 41 ± 15 years; 58 bilateral and 61 unilateral involvements for a total of 177 joints) and 20 healthy volunteers (9 male and 11 female; 40 ± 13 years; 40 joints) were included in this prospective study. Based on DTI of the jaw in the resting state, the diffusion parameters, apparent diffusion coefficient (ADC), fractional anisotropy (FA), λ1, λ2, and λ3 of the superior and inferior heads of the LPM (SHLPM and IHLPM) were measured. Patients with TMD with normal disc position (ND), anterior disc displacement with reduction (ADWR), and anterior disc displacement without reduction (ADWOR) were compared. Results: Patients with TMD overall, and ADWR and ADWOR subgroups had significantly higher ADC, λ1, λ2, and λ3 in both the SHLPM and IHLPM than those in volunteers (p < 0.05 for all), whereas the ND subgroup only had significantly higher ADC and λ1 (p < 0.001). Meanwhile, significant differences in FA in the SHLPM and IHLPM were found between volunteers and ADWOR (p = 0.014 and p = 0.037, respectively). Among the three TMD subgroups, except for λ3 and FA in the ADWR subgroup, ADWR and ADWOR subgroups had significantly higher ADC, λ1, λ2, and λ3 and lower FA than those in the ND group (p < 0.050). There was no significant difference in diffusion variables between ADWR and ADWOR. In ADWOR, the osteoarthritis group had significantly higher λ3 and lower FA values in the IHLPM than those in the non-osteoarthritis group. Conclusion: DTI successfully detected functional changes in the LPM in patients with TMD. The unsynchronized diffusivity changes in the LPM in different subgroups of TMD signified the possibility of using diffusion parameters as indicators to identify the severity of LPM hyperfunction at various stages of TMD.

• 대한가정학회지
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• 제46권6호
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• pp.89-100
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• 2008

The purpose of this study was to provide basic data for the familial voluntary service of the Healthy Family Center and then verify the effectiveness of its application in order to improve family healthy through a familial voluntary service. Study subjects were both volunteers who belonged to family volunteer corps of 12 Healthy Family Centers. Collected data was analyzed SPSS WIN 12.0 program. The results were as followed. First, a 54.1% of subjects is taking part in a familial voluntary service, while a 45.9% of them is not. Their positive intention of future participation is a 77.4%. The period of participation is from 6 months to two years. The frequency of participation is once or twice a month, and the length of activities per participation is for 3 hours. They have taken part in the service with a variety of public relations, and their motive of participation is by and large selfish. Second, as for the influence of participation in a familial voluntary service upon family healthy, the family healthy of participant group is higher in all the four sub-variables of family healthy than that of other groups. The group of which frequency of participation is once a week is better in family communication than the group of which frequency of participation is once or twice per month. The group of which motive of participation is altruistic is higher in sharing a value system among families than the group of which motive of participation is selfish.

• 한국임상약학회:학술대회논문집
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• 한국임상약학회 2007년도 추계학술대회
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• pp.192-192
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• 2007

• Journal of Pharmaceutical Investigation
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• 제10권3호
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• pp.1-4
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• 1980

In order to increase the solubility and antibacterial activity of ampicillin, the lysinomethylene ampicillin trihydrate was synthesized. The blood concentrations of ampicillin trihydrate and synthetic lysinomethylene ampicillin trihydrate were determined in 10 healthy male volunteers by using large plate method with Sarcina lutea ATCC 9341. The mean blood concentration of synthetic lysinomethylene ampicillin trihydrate was higher ca. 1.3 times than that of ampicillin trihydrate in 10 test subjects after oral administration.

• 대한핵의학회:학술대회논문집
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• 대한핵의학회 2005년도 제44차 추계학술대회 및 총회
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• pp.315.1-315.1
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• 2005

• 대한방사선협회지
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• 제30권1호
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• pp.63-69
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• 2004

Purpose : We underwent this study to evaluate the factors which influence labelling efficiency when modified in vivo erythrocyte labeling technique was used. Materials and methods : Thirty healthy volunteers (M : F = 19 : 11, age : 25$\pm$2yrs)