• Journal of Pharmaceutical Investigation
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• v.36 no.2
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• pp.143-148
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• 2006

Finasteride $[N-(1, 1-dimethylethyl)-3-oxo-4-aza-5{\alpha}-androst-1-ene-17{\beta}-carboxamide]$ is a 4-aza-3-oxosteroidal inhibitor of human $5{\alpha}-reductase$. The purpose of the present study was to evaluate the bioequivalence of two finasteride tablets, $Proscar^{\circledR}$ (MSD Korea Ltd.) and Procare (Hana Pharm. Co., Ltd.), according to the guidelines of the Korea Food and Drug Administration (KFDA). The release of finasteride from the two finasteride formulations in vitro was tested using KP VIII Apparatus II method with various dissolution media (pH 1.2, 4.0, 6.8 buffer solution and water). Twenty six healthy male subjects, $23.7\;{\pm}\;2.24$ years in age and $67.2\;{\pm}\;8.55\;kg$ in body weight, were divided into two groups and a randomized $2\;{\time}\;2$ cross-over study was employed. After two tablets containing 5 mg as finasteride was orally administered, blood samples were taken at predetermined time intervals and the concentrations of finasteride in serum were determined using HPLC with UV detector. 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 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, $Proscar^{\circledR}$, were 6.39, 4.65 and -13.9% 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 0.800 to log 1.25 $(e.g.,\;log\;0.990{\sim}log\;1.14\;and\;log\;0.977{\sim}log\;1.13 for\;AUC_t\;and\;C_{max},\;respectively)$. Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating Procare tablet was bioequivalent to $Proscar^{\circledR}$ tablet.

• Korean Journal of Clinical Pharmacy
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• v.20 no.3
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• pp.255-261
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• 2010

Cefprozil is a broad-spectrum oral beta-lactam cephalosporin consisting of cis- and trans-isomeric mixture whose ratio is approximately 90:10. Cefprozil is used to treat certain infections caused by bacteria such as bronchitis and ear, skin, and throat infections. The purpose of the present study was to evaluate the bioequivalence of two cefprozil tablets, $Cefzil^{(R)}$ tablet 250 mg (BMS Pharmaceutical Korea., Ltd.) and Procezil tablet 250 mg (Hanmi Pharm. Co., Ltd.), according to the guidelines of the Korea Food and Drug Administration (KFDA). The in vitro release of cefprozil from the two cefprozil formulations were tested using KP VIII Apparatus I method with water dissolution media. Thirty five healthy male subjects, $24.00{\pm}1.53$ years in age and $69.77{\pm}9.99$ kg in body weight, were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After four tablets containing 1000 mg as cefprozil were orally administered, blood samples were taken at predetermined time intervals and the concentrations of cefprozil in serum were determined using HPLC/UV detector. The dissolution profiles of two formulations were similar in water tested dissolution media. The pharmacokinetic parameters such as $AUC_t$, $C_{max}$ and $T_{max}$ on the basis of total-cefprozil were calculated, and computer program (K-BE Test 2002) 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, $Cefzil^{(R)}$ tablets, were -0.81%, -3.00% and -6.83% 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 0.9515~log 1.0454 and log 0.9613~log 1.0465 for $AUC_t$ and $C_{max}$, respectively). Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating Procezil tablet was bioequivalent to $Cefzil^{(R)}$ tablet.

• Korean Journal of Clinical Pharmacy
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• v.20 no.3
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• pp.235-241
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• 2010

Bambuterol hydrochloride, dimethylcarbamic acid 5-[2-(1,1-dimethylethyl)amino-1-hydroxyethyl]-1,3-phenylene ester hydrochloride, is the prodrug of active ${\beta}_2$-adrenergic metabolite terbutaline. The purpose of the present study was to evaluate the bioequivalence of two bambuterol hydrochloride tablets, $Bambec^{(R)}$ tablet 10 mg (Yuhan Co., Ltd.) and Bambucol tablet 10 mg (Sam Chun Dang Pharm. Co., Ltd.), according to the guidelines of Korea Food and Drug Administration (KFDA). In vitro release of bambuterol from two bambuterol hydrochloride formulations was tested using KP VIII Apparatus II method with various dissolution media. Twenty eight healthy male Korean volunteers, $23.86{\pm}1.65$ years in age and $68.98{\pm}9.58$ kg in body weight, were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After two tablets containing 10 mg as bambuterol hydrochloride were orally administered, blood samples were taken at predetermined time intervals, and the concentrations of bambuterol in serum were determined using column switching HPLC with UV detector. 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 ANOVA test with K-BE Test 2002 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, $Bambec^{(R)}$, were -8.10%, -3.82% and 12.65% 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 (i.e., log 0.8093~log 1.0302 and log 0.8564~log 1.1280 for $AUC_t$ and $C_{max}$, respectively). Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating Bambucol tablet 10 mg was bioequivalent to $Bambec^{(R)}$ tablet 10 mg.

• Asian Pacific Journal of Cancer Prevention
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• v.17 no.1
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• pp.197-200
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• 2016

Background: Wedge filters are commonly used in radiation oncology for eliminating hot spots and creating a uniform dose distribution in optimizing isodose curves in the target volume for clinical aspects. These are some limited standard physical wedges ($15^{\circ}$, $30^{\circ}$, $45^{\circ}$, $60^{\circ}$),or creating an arbitrary wedge angle, like motorized wedge or dynamic wedge,${\ldots}$ The new formulation is presented by the combination of wedge fields for determining an arbitrary effective wedge angles. The isodose curves also are derived for these wedges. Materials and Methods: we performed the dosimetry of Varian Clinac 2100C/D with Scanditronix Wellhofer water blue phantom, CU500E, OmniPro - Accept software and 0.13cc ionization chamber for 6Mv photon beam in depth of 10cm (reference depth) for universal physical wedges ($15^{\circ}$, $30^{\circ}$, $45^{\circ}$, and $60^{\circ}$) and reference field $10.10cm^2$. By combining the isodose curve standard wedge fields with compatible weighting dose for each field, the effective isodose curve is calculated for any wedge angle. Results: The relation between a given effective wedge angle and the weighting of each combining wedge fields was derived. A good agreement was found between the measured and calculated wedge angles and the maximum deviation did not exceed $3^{\circ}$. The difference between the measured and calculated data decreased when the combined wedge angles were closer. The results are in agreement with the motorized single wedge appliance in the literature. Conclusions: This technique showed that the effective wedge angle that is obtained from this method is adequate for clinical applications and the motorized wedge formalism is a special case of this consideration.

• Journal of Pharmaceutical Investigation
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• v.36 no.1
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• pp.67-73
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• 2006

Lornoxicam is a nonsteroidal anti-inflammatory drug that decreases prostaglandin synthesis by inhibiting cyclooxygenase. It has analgesic, antipyretic and antiinflammatory effects. The purpose of the present study was to evaluate the bioequivalence of two lornoxicam tablets, $Xefo^{\circledR}$ (Hyundai Pharmaceutical Ind. Co., Ltd.) and Lornocam (Samchundang Pharmaceutical Co., Ltd.), according to the guidelines of the Korea Food and Drug Administration (KFDA). The release of lornoxicam from the two lornoxicam formulations in vitro was tested using KP VIII Apparatus II method with various dissolution media (pH 1.2, 4.0, 6.8 buffer solution and water). Twenty eight healthy male subjects, $24.39{\pm}1.95$ years in age and $68.63{\pm}7.25$ kg in body weight, were divided into two groups and a randomized $2\;{\time}\;2$ cross-over study was employed. After a single tablet containing 4 mg as lornoxicam was orally administered, blood samples were taken at predetermined time intervals and the concentrations of lornoxicam in serum were determined using HPLC with UV detector. 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 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, $Xefo^{\circledR},$ were -1.56%, 2.16% and -17.12% 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., $log\;0.90{\sim}log\;1.05$ and $log\; 0.88{\sim}log\;1.17$ for $AUC_t\;and\;C_{max},$ respectively). Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating Lornocam tablet was bioequivalent to $Xefo^{\circledR}$ tablet.

• Clinical and Experimental Pediatrics
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• v.46 no.3
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• pp.265-270
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• 2003

Purpose : To characterize the infants under 3 months of age with urinary tract infections(UTIs), and especially patients with bacteremia or meningitis Methods : Hospital records of all the infants under 3 months of age discharged from our hospital for 69 consecutive months with the diagnosis of initial episode of UTI were reviewed. UTI was defined when patients had fever with pyuria, and had urine culture results of ${\geq}10^5$ colony forming units/mL from a bag specimen. Patients with previously known urologic abnormality or immunodeficiency were excluded. Nosocomial infections were also excluded from the study. Results : The male:female ratio was 35 : 6. Of the urine cultures, 40(97.6%) yielded single pathogen, one yielded two pathogens. Escherichia coli was the predominant isolate from the urine. Five patients(12%) also had bacteremia. Pathogens isolated from the blood cultures were E. coli(4) and Enterococcus faecalis(1). No patient had culture-positive meningitis or cerebrospinal fluid pleocytosis. Clinical or laboratory findings between patients with and without bacteremia were not different significantly. The rate of vesicoureteral reflux(VUR) was 44%. The sensitivity of ultrasound for detection of VUR was 38%; specificity was 50%. Conclusion : Clinical and laboratory data were not helpful for identifying patients with bacteremia at the time of presentation. Consequently, blood cultures need to be obtained from all febrile infants under 3 months of age with UTIs. A large-scale study including the indication of lumbar puncture for infants with a febrile UTI and study of evaluation and treatment of infants under 3 months of age with UTIs are required.

• Pediatric Infection and Vaccine
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• v.13 no.2
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• pp.147-155
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• 2006

Purpose : The purpose of this study is to evaluate epidemiological data of pathogens obtained from stool exams and compare them with the clinical course in pediatric patients with symptoms of acute gastroenteritis. Methods : Subjects were selected from patients presenting with symptoms of acute gastroenteritis who visited the outpatient clinic or who were admitted to the Dankook University Hospital from December of 2004 to December of 2005. Stool exams for 17 pathogens was performed. RT-PCR was used to detect norovirus and enzyme-linked immunoabsorbant assay (ELISA) was used to detect rotavirus, adenovirus and astrovirus in the subjects stool samples. Ten different species of bacteria(Salmonella spp., Shigella spp., Clostridium perfrigens, Campylobacter spp., Escherichia coli, Vibrio spp., Staphylococcus aureus, Bacillus cereus, Yersinia spp., and L. monocytogenes) were each selectively cultivated and enzyme immunoassays(EIA) was used to test for antigens for C. parvum, E. histolytica and G. lamblia. Retrospective chart review was performed for comparisons of clinical manifestations. Results : A total of 215 subjects was selected and of these 89 cases(41.4%) showed positive results for at least one pathogen. Male to female ratio was 1.3:1. Age distribution showed 4 cases less than one month(4.5%), 4 cases from 1~2 months(4.5%), 24 cases from 3~12 months(26.7%), 47 cases form 13~48 months(52.8%), 10 cases greater than 48 months (21.2%). Viruses showed the greatest proportion of cases with 68 subjects(77.5%), of these rotavirus being the most commonly reported in 50 cases. Bacteria was identified in 26 cases (29.2%), of these nontyphoidal salmonella was noted in 10 cases. Protozoa followed with 21 cases(23.6%), of these C. parvum was noted in 11 cases and G. lamblia was noted in 10 cases. Mixed infections with more than two pathogens were seen in 22 cases(24.7%), of these viral infection with accompanying parasitic infection was seen in 12(54.5%) cases. Conclusion : In this study we examined various pathogens known to cause acute gastroenteritis in children. Further studies for various pathogens can provide useful information for management of the acute gastroenteritis.

• The Journal of Korean Academy of Prosthodontics
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• v.49 no.1
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• pp.22-28
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• 2011

Purpose: This article attempted to examine how teeth for restoration is made in a clinical practice and utilize it as future educational material of teeth formation and basic data for additional research. Materials and methods: This experiment investigated the models sent to milling center for production of zirconia crowns. After scanned with Lava CAD/CAM System (3M ESPE, Seefeld, Germany), they are measured on 'ImageJ (version 1.32j, National Institutes of Health, USA)' program and compared and analyzed. Convergence angle from mesio-distal surfaces and bucco-lingual surfaces of each teeth are measured. Also, bucco-lingual diameter of the region lowered as much as 0.4 mm from incisal edge in anterior teeth except canines.(This measure is defined as the Peak 0.4) The analysis of data between each group was conducted by Windows SPSS statistic program, and was proved significant on 95% confidence level by independent t-test, one-way ANOVA and multiple analysis (Sheff${\'{e}}$ test). Results: The mean value of convergence angle was $18.67^{\circ}$ It is ranked as molar ($26.70^{\circ}$) > premolar ($16.87^{\circ}$) > anterior teeth ($14.81^{\circ}$) in the order of mesio-distal convergence angle; anterior teeth ($22.32^{\circ}$) > molar ($20.93^{\circ}$) > premolar ($15.41^{\circ}$) in the order of bucco-lingual convergence angle. The mean value of Peak 0.4 was 1.18 mm. Conclusion: Convergence angle of abutment of zirconia all ceramic crown has difference depending on the location in the arch. Due to the nature of production of zirconia all ceramic crown, convergence angle of abutment and line angle finishing degree can have an effect on internal suitability of restoration.

• Journal of Korean Academy of Nursing
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• v.12 no.1
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• pp.1-12
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• 1982

Presently, there is increasing demand for geriatric nursing care due to increasing proportion of elderly population and extended age. And, of particular importance in deforming the effectiveness of nursing care given to the elderly is the attitude of nursing personnel toward the elderly patient. This study was intendent to investigate the attitudes of baccalaureate nursing students toward the elderly, and to investigate any possible correlation between these attitudes and the following variables: the students' levels (freshman, sophomore, junior, senior), their preferences for var-ious fields of specialization in nursing after graduation, their clinical experiences with geriatric-patients, their personal experience with elderly family members, their educational experience of the elderly's health problems and geriatric nursing, and their experience with relatives and acquaintances over 60 years of age. Therefore, the purpose of this study was to compile basic data about the attitudes of nursing students toward the elderly in order to contribute to the improvement of geriatric nursing. The subjects for this study were 259 nursing students: 163 in the College of Nursing at E-womans University., and 96 in the Department of Nursing in K. College. Data was collected from the 11th of Sep., to the 8th of Oct., 1981, using the Tuckman-Lorge Attitude Questionnaire which contained 131 items excepting 6 items. The attitudes toward the elderly was scored by the use of mean and standard deviation. The relations between attitudes toward the elderly and six independent vairables were analysed by T-test. The results which were obtained are as follows : 1. The attitude score of nursing students was M=71.67 S.D= 16.18. Nursing students agreed with 54.8% of the stereotypic statements, and they had stereotypic attitudes toward the elderly relatively. (P<0.01). 2. There was a significant difference between the attitudes of nursing students toward the elderly, and sophomores had a less stereotypic attitudes than juniors and seniors (P<0.01). 3. There was significant difference between the attitudes toward the elderly and the preferences for various fields of specialization in nursing after graduation, and nursing students those who wanted maternity fields had a more stereotypic attitudes than others (P<0.05, p<0.01). 4. There was no significant difference between the attitudes toward the elderly and the clinical experience with the geriatric patients (P>0.05). 5. There was no significant difference between the attitude3 toward the elderly and the personal experience with elderly family members (F>0.05). 6. There was no significant difference between the attitudes toward the elderly and the educational experience of the elderly's health problems and geriatric nursing (P>0.05). 7. There was no significant difference between the attitudes toward the elderly and the experience with relatives and acquaintances over 60 years of age (P>0.05).

• The Journal of Korean Society for Radiation Therapy
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• v.16 no.2
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• pp.25-32
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• 2004

Purpose : The simulator is used to determine patient field and ensure the treatment field, which encompasses the required anatomy during patient normal movement such as during breathing. The latest simulator provide real time display of still, flouroscopic and digitalized image, but conventional simulator is not yet. The purpose of this study is to introduce digital image capture system(DICS) using conventional simulator and clinical case using digital captured still and flouroscopic image. Methods and materials : We connect the video signal cable to the video terminal in the back up of simulator monitor, and connect the video jack to the A/D converter. After connection between the converter jack and computer, We can acquire still image and record flouroscopic image with operating image capture program. The data created with this system can be used in patient treatment, and modified for verification by using image processing software. (j.e. photoshop, paintshop) Result : DICS was able to establish easy and economical procedure. DCIS image was helpful for simulation. DICS imaging was powerful tool in the evaluation of the department specific patient positioning. Conclusion : Because the commercialized simulator based of digital capture is very expensive, it is not easily to establish DICS simulator in the most hospital. DICS using conventional simulator enable to utilize the practical use of image equal to high cost digitalized simulator and to research many clinical cases in case of using other software program.