• Journal of Pharmaceutical Investigation
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• v.32 no.2
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• pp.135-140
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• 2002

Cefadroxil is a semi-synthetic cephalosporin active against many Gram-positive and Gram-negative bacteria. The drug has been used for the treatment of the urinary and respiratory tract infections when caused by susceptible strains of the designated microorganism. The purpose of the present study was to evaluate the bioequivalence of two cefadroxil capsules, Duricef (Bo Ryung Pharmaceutical Co. Ltd.) and Hanacef (Korean Pharmaceutical Co. Ltd.), according to the guidelines of Korea Food and Drug Administration (KFDA). The cefadroxil release from the two cefadroxil capsules in vitro was tested using KP VII Apparatus II method with various different kinds of dissolution media (pH 1.2, 4.0, 6.8 buffer solution and water). Twenty four normal male volunteers, $21.58{\pm}2.43$ years in age and $70.74{\pm}10.29$ kg in body weight, were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After one capsule containing 500 mg as cefadroxil was orally administered, blood was taken at predetermined time intervals and the concentrations of cefadroxil in serum were determined using HPLC with UV detector. The dissolution profiles of two cefadroxil capsules were very similar at all 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 $AUC_t\;and\;C_{max}$ and untransformed $T_{max}$. The results showed that the differences in $AUC_t,\;C_{max}\;and\;T_{max}$ between two capsules based on the Duricef were 0.05%, -5.29% and 4.53%. There were no sequence effects between two capsules in these parameters. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of log(0.8) to log(1.25) $(e.g.,\;log(0.95){\sim}log(1.05)\;and\;log(0.87){\sim}log(1.02)$ for $AUC_t\;and\;C_{max}$, respectively). The 90% confidence interval using untransformed data was within ${pm}20%$ $(e.g.,\;-6.75{\sim}15.74\;for\;T_{max})$. All parameters met the criteria of KFDA guideline for bioequivalence, indicating that Hanacef capsule is bioequivalent to Duricef capsule.

• 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.

• Journal of Pharmaceutical Investigation
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• v.41 no.5
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• pp.317-322
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• 2011

Sertraline HCl, (1S-cis)-4-(3, 4-dichloro-phenyl)-1, 2, 3, 4-tetrahydro-N-methyl-l-naphthalenamine hydrochloride, is a potent and selective serotonin reuptake inhibitor which is used in the treatment of depression and obsessivecompulsive disorders. The purpose of the present study was to evaluate the bioequivalence of two sertraline HCl tablets, Traline tablet (Myungin Pharm. Co. Ltd.) and Zoloft$^{(R)}$ tablet (Pfizer Inc.), according to the guidelines of the Korea Food and Drug Administration (KFDA). The in vitro release of sertraline from the two sertraline HCl formulations was tested using KP VIII Apparatus II method with various dissolution media. Twenty four healthy Korean male volunteers, $23.50{\pm}1.74$ years in age and $64.09{\pm}7.10\;kg$ in body weight, were divided into two groups and a randomized $2{\times}2$ crossover study was employed. After a single tablet containing 50 mg as sertraline HCl was orally administered, blood samples were taken at predetermined time intervals and the concentrations of sertraline in serum were determined using an online columnswitching HPLC method with UV/Vis detection. 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 computer programs (Equiv Test and K-BE Test) were utilized for the statistical analysis of the parameters using logarithmically transformed $AUC_t$, $C_{max}$ and un-transformed $T_{max}$. The results showed that the differences between two formulations based on the reference drug, Zoloft$^{(R)}$ tablet, were 0.04, 3.26 and -1.29% 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 log0.8 to log1.25. Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating Traline tablet was bioequivalent to Zoloft$^{(R)}$ tablet.

• Journal of Pharmaceutical Investigation
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• v.41 no.2
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• pp.117-123
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• 2011

Loxoprofen sodium, a 2-phenylpropionate non-steroidal anti-inflammatory drug (NSAID), has marked analgesic and antipyretic activities and relatively weak gastrointestinal ulcerogenicity. The purpose of the present study was to evaluate the bioequivalence of two loxoprofen sodium tablets, Hana loxoprofen sodium tablet (Hana Pharm. Co., Ltd.) and Dongwha Loxonin$^{(R)}$ tablet (Dongwha Pharm. Co., Ltd.), according to the guidelines of the Korea Food and Drug Administration (KFDA). The in vitro release of loxoprofen from the two loxoprofen sodium formulations was tested using KP IX Apparatus II method with various dissolution media. Twenty four healthy Korean male volunteers, $22.83{\pm}1.862$ years in age and $69.92{\pm}9.14$ kg in body weight, were divided into two groups and a randomized $2{\times}2$ crossover study was employed. After a single tablet containing 60 mg as loxoprofen sodium was orally administered, blood samples were taken at predetermined time intervals and the concentrations of loxoprofen in serum were determined using a online column-switching HPLC method with UV/Vis detection. 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 computer programs (Equiv Test and K-BE Test 2002) were utilized for the statistical analysis of the parameters using logarithmically transformed $AUC_t$, $C_{max}$ and un-transformed $T_{max}$. The results showed that the differences between two formulations based on the reference drug, Dongwha Loxonin$^{(R)}$ tablet, were 2.03, 2.99 and -9.49% 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 log0.8 to log1.25 (e.g., log0.9831~log1.0535 and log0.9455~log1.1386 for $AUC_t$ and $C_{max}$, respectively). Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating Hana loxoprofen sodium tablet was bioequivalent to Dongwha Loxonin$^{(R)}$ tablet.

• Journal of Pharmaceutical Investigation
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• v.40 no.1
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• pp.51-57
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• 2010

Losartan potassium, 2-butyl-4-chloro-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-methanol mono-potassium salt, is a new class of antihypertensive agents, and is an antagonist in angiotensin receptor. The purpose of the present study was to evaluate the bioequivalence of two Losartan potassium tablets, Cozaar tablet (MSD Pharmaceutical Co., Ltd.) and Losata tablet (Kyung Dong Pharmaceutical Co., Ltd.), according to the guidelines of the Korea Food and Drug Administration (KFDA). The release of losartan from the two losartan potassium formulations in vitro was tested using KP VIII Apparatus II method with various dissolution media. Twenty eight healthy male subjects, $23.86{\pm}1.80$ years in age and $67.27{\pm}6.60\;kg$ in body weight, were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After a single tablet containing 50 mg as losartan potassium was orally administered, blood samples were taken at predetermined time intervals, and the concentrations of losartan in serum were determined using HPLC with fluorescence 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 Equiv Test/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, Cozaar, were -2.70%, 1.45% and 2.31% 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 0.8852~log 1.0655 and log 0.8319~log 1.2342 for $AUC_t$ and $C_{max}$, respectively). Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating Losata tablet was bioequivalent to Cozaar tablet.

• Journal of Korean Physical Therapy Science
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• v.10 no.2
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• pp.37-41
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• 2003

The aim of this study is to present the basic reference data Effect of uneffected side insole on Gait Pattern in Hemiplegia Patients. The basic gait parameters were extracted from 10 Adult Hemiplegia Patients, 5 left Hemiplegia Patients and 5 right Hemiplegia Patients, 50 to 60 years of age using VICON 512 Motion Analyzer. The results were as follows; 1) The mean Cadence of the shoes to the 1cm insole in shoes were $70.58{\pm}12.67\;steps/min$, to $77.28{\pm}14.58\;steps/min$.(p>0.05) 2) The mean Walking Speed of the shoes to the 1cm insole in shoes were $0.40{\pm}0.17\;m/s$, to $0.49{\pm}0.18\;m/s$.(p>0.05) 3) The mean Stride Length of the shoes to the 1cm insole in shoes were $0.67{\pm}0.20\;m$, to $0.75{\pm}0.19m$.(p>0.05) 4) The mean anterior angles of pint on the pelvic tilt for different the shoes to the 1cm insole in shoes were $13.22{\pm}7.25^{\circ}$, to $11.68{\pm}4.02^{\circ}$.(p>0.06) 5) The mean maximal angles of pint on the hip flexion motion for different the shoes to the 1cm insole in shoes were $24.62{\pm}8.35^{\circ}$, to $24.74{\pm}9.12^{\circ}$.(p>0.05) 6) The mean maximal angles of joint on the knee flexion motion for different the shoes to the 1cm insole in shoes were $34.27{\pm}16.71^{\circ}$, to $35.93{\pm}18.22^{\circ}$.(p>0.05) insole in shoes were $15.97{\pm}7.72^{\circ}$, to $18.77{\pm}11.03^{\circ}$.(p>0.05) 7) The mean maximal angles of joint on the ankle dorsiflexion motion for different the shoes to the 1cm. 8) The mean maximal angles of joint on the ankle plantarflexion motion for different the shoes to the 1cm insole in shoes were $-4.24{\pm}10.66^{\circ}$, to $-7.04{\pm}11.00^{\circ}$.(p<0.05)

• Journal of Korean Ophthalmic Optics Society
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• v.18 no.4
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• pp.541-548
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• 2013

Purpose: Marrow stromal cells (MSCs) have been known for their potential to trans-differentiate into neural and glial cells in vitro and in vivo. To investigate the influence of the developing host environment on the survival and morphological and molecular differentiation, murine MSCs transplanted into the eye of Brazilian opossum (Monodelphis domestica). Methods: Enhanced green fluorescent protein (GFP) - expressing MSCs were transplanted into developing Brazilian opossums. Animals were allowed to survive for up to 4 weeks after transplantation, at which time the eyes were prepared for immunohistochemical analysis. Results: Some transplanted MSCs survived and showed morphological differentiation into neural cells with some processes within the host vitreous chamber. Some transplanted cells expressed class III ${\beta}$-tubulin (TuJ1, a marker for neuronal cells) or glial fibrillary acid protein (GFAP, a marker for glial cells) or Nestin (a marker for neural stem cells). In addition, some transplanted cells were located in ganglion cell layer but did not show morphological and molecular differentiation. Conclusions: Our result show that the most effective stage of development for transplantation into the retina was postnatal day 16, which retinas developmentally corresponded to postnatal day 4-5 days mouse retina based on cell differentiation and lamination patterns. The present findings suggest that the age of the host appears to play a key role in determining cell fate in vivo.

• Ocean and Polar Research
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• v.26 no.2
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• pp.245-253
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• 2004

The Intertropical Convergence Zone (ITCZ), where the southeast and northeast trade winds converge, is the effective climatological barrier that separates the southern and northern hemispheres in dust budget. Asian and N. American dusts dominate in fhe Pacific north of the ITCZ, while Central and S. American dust prevails south of the ITCZ. In order to understand the nature of latitudinal and depth-related variations of mineral composition in terms of relative position to the ITCZ, deep-sea core sediments were collected from $9^{\circ}N$ to $17^{\circ}N$ at a $2^{\circ}N$ interval along the $131.5^{\circ}W$ meridian and analyzed for mineral composition. The amount of illite in surface sediments decreases gradually from 65% at $17^{\circ}N\;to\;31^{\circ}N$ to 31% at 9f. In contrast, smectite increases from 11% to 56% southward. The observed mineralogical variation toward the ITCZ is attributed to the increased supply of volcaniclastic material transported via the southeast trade winds from the Central and South America source regions. Smectite-illite transition, a phenomenon that the amount of smectite increases over illite, occurs at around $10^{\circ}N$, the northern margin of the ITCZ. This result indicates that the change in latitudinal position of the ITCZ in geologic past could be recorded as a form of smectite-illite transition in deep-sea cores. The studied cores show down-core variation of mineral composition from illite-rich at the surface to smectite-rich clay suit at depths, similar to the latitudinal variation. The smectite-illite transitions observed in these cores are likely the records of changes in latitudinal position of the ITCZ. The depth and age of smectite-illite transition is getting shallower and younger toward equator, implying that the ITCZ was located farther north during late Tertiary and has shifted southward to the present position of $5^{\circ}N-10^{\circ}N$.

• Journal of Distribution Research
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• v.16 no.3
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• pp.33-75
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• 2011

The ownership structure of a franchise system is determined by the franchisor's strategic choice. A close look at the extant theories and perspectives in economics and management such as resource scarcity theory, agency theory, transaction cost analysis, and mixed ownership theory reveals that firms choose their ownership structure for the sake of economic efficiency, profit potentials, the chance of survival, and other strategic concerns. The present study, on the basis of strategic choice perspective, reviews the divergent theories of a franchise system's ownership structure and its determinants, thus providing a theoretical framework for comparing the contradictory arguments along the several critical dimensions. We also developed and tested the conflicting hypotheses regarding key determinants of ownership structure including firm's age, size, transaction-specific investments, uncertainty, and risk-sharing propensity. Using a FDD (Franchise Disclosure Document) data set of 543 Korean franchisors, we found that the years in business, the total number of employees, days of training, the inverse of the years of franchising, and the requirement of royalty payment have positive relationships with the proportion of company-owned outlets to total number of outlets. On the other hand, the proportion of company-owned outlets was found to have negative relationships with the total number of outlets and the extent of geographic dispersion of outlets, but to have no significant relationships with the initial investment required and the inverse of contract length. Based on the findings, we provide several theoretical and managerial implications for studying ownership structure of franchise systems.

• The Journal of the Korea Contents Association
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• v.15 no.11
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• pp.658-671
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• 2015

The present study explores the effect of blended action learning program on the improvement of the self-directed learning skills of university students. For this, students in the college of education at D University located in the capital area were selected to form 30 students of the experimental group and 30 of the control group. The average age of the subjects is 22.3. They are students in the $2^{nd}$ to $4^{th}$ year of university and the demographic background is relatively homogeneous. The experiment was conducted in the Sociology of Education class (a teacher training course). The self-directed learning skills were pre-tested at the beginning of the term. After that, the experimental group had the class with blended action learning program, and the control group had the class with action learning program. The post-test was carried out at the end of the term. For data analysis, ANCOVA was carried out to compare the scores on post-test of the two groups in consideration of the scores on the pre-test. The results show that first, for the improvement of self-directed learning skills of university students, blended action learning program is more effective than action learning program. Second, in the class for learners with lower degree of cognition and experience, blended action learning program was more effective than action learning program. Third, in terms of management of learning resources and utilization of learning strategies, both action learning program and blended action learning program were not effective. In summary, for improvement of the self-directed learning skills of university students, action learning program, which is a learning method focused on learner's participation and practice, is more effective than the traditional collective lecture among diverse teaching methods. Yet in consideration of the elementary level of university students in terms of intelligence and experience, active use of blended action learning program is required.