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Bioequivalence of Famvir Tablet 750 mg to Famcivir Tablet 750 mg (Famciclovir 750 mg) (팜비어 정 750밀리그람(팜시클로버 750밀리그람)에 대한 팜시버 정 750밀리그람의 생물학적동등성)

  • Kim, Se-Mi;Yoon, Hwa;Yoo, Hee-Doo;Kim, Kyung-Ran;Kang, Hyun-Ah;Cho, Hea-Young;Lee, Yong-Bok
    • Journal of Pharmaceutical Investigation
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    • v.38 no.3
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    • pp.199-205
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    • 2008
  • Famciclovir, 9-(4-hydroxy-3-hydroxymethylbut-1-yl) guanine, is an oral prodrug of the antiherpesvirus nucleoside analogue, penciclovir. In human, famciclovir is orally well absorbed and then undergoes extensive first pass metabolism to penciclovir and essentially no parent compound is recovered from plasma or urine. The purpose of the present study was to evaluate the bioequivalence of two famciclovir tablets, Famvir tablet 750 mg (Novartis Korea Ltd.) and Famcivir tablet 750 mg (Hanmi Pharmaceutical. Co., Ltd.), according to the guidelines of the Korea Food and Drug Administration (KFDA). The release of famciclovir from the two famciclovir formulations in vitro was tested using KP VIII Apparatus II method with water. Twenty six healthy male subjects, $23.38{\pm}1.72$ years in age and $68.59{\pm}7.84\;kg$ in body weight, were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After a single tablet containing 750 mg as famciclovir was orally administered, blood samples were taken at predetermined time intervals and the concentrations of penciclovir in serum were determined using HPLC with UV detector. The dissolution profiles of two formulations ere similar at water. 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, $Famvir^{(R)}$ tablet 750 mg, were -0.53%, 1.12% and -24.82% 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., $log\;0.9569{\sim}log\;1.0423$ and $log\;0.8763{\sim}log\;1.2136$ for $AUC_t$ and $C_{max}$, respectively). Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating Famcivir tablet 750 mg was bioequivalent to Famvir tablet 750 mg.

Treatment Outcome and Prognostic Factors of Cushing's Disease in Adults (성인 쿠싱병의 치료성적과 예후인자)

  • Park, Chul-Kee;Hwang, Sung Kyun;Gwak, Ho-Shin;Yoo, Heon;Chung, Young Seob;Paek, Sun Ha;Kim, Dong Gyu;Jung, Hee-Won;Kim, Seong Yeon;Hong, Seung Kuan
    • Journal of Korean Neurosurgical Society
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    • v.29 no.10
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    • pp.1316-1321
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    • 2000
  • Objectives : The authors analyzed the surgical series of Cushing's disease to evaluate the proper treatment policy and to verify the possible prognostic factors. Material and Methods : Of 50 patients diagnosed as Cushing's disease and operated at Department of Neurosurgery of our institute between 1988 and 1999, 48 patients with available medical records were analyzed retrospectively. Mean follow-up period was 48 months(3 to 109 months). Preoperative diagnosis was made after evaluating the patients with multiple-stage endocrinological studies and 31 selective patients were evaluated with inferior petrosal sinus sampling(IPSS). Magnetic resonance imaging(MRI) and/or high resolution computerized tomography(CT) was done in all patients. A total of 51 transsphenoidal adenomectomy(TSA) were performed including 3 revision for initial surgical failure cases. Remission was decided on the basis of both endocrinological criteria and clinical status. Radiation and/or ketoconazole therapy were applied to failed cases. For the verification of prognostic factors, the authors evaluated the statistical significance of multiple variables over remission rate by chi-square test. Result : Sensitivity of IPSS for central localization was 93.5% which was better than that of MRI(87.5%). But for lateralization, it was 72.4% for IPSS versus MRI 90.5%. Success rate of TSA was 82%(42/51) and recurrence rate was 9%(4/48). When including adjuvant treatments for surgically failed cases, overall success rate was 89.6% and all of 3 reoperated cases(TSA) due to recurrence were successful. Significant complication occurred in 7.8%(4/51) after TSA including hypopituitarism, diabetes insipidus, and visual loss. Non-existence of tumor in MRI and prolonged symptom duration(>3 years) were significant prognostic factors. Conclusion : TSA can be considered as initial treatment for Cushing's disease. In surgically failed cases, multiple treatment modality may improve the overall outcome and repeated TSA for recurrent cases seem to provide similar success.

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Bioequivalence of Procare Tablet to Proscar® Tablet (Finasteride 5 mg) (프로스카 정(피나스테리드 5 mg)에 대한 푸로케어 정의 생물학적동등성)

  • Kang, Hyun-Ah;Cho, Hea-Young;Lee, Yong-Bok
    • 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.

Bioequivalence of Losata Tablet to Cozaar Tablet (Losartan Potassium 50 mg) using HPLC with Fluorescence Detector (고속액체크로마토그래피-형광검출기를 이용한 코자 정(로자탄칼륨 50 mg)에 대한 로사타 정의 생물학적동등성)

  • Kang, Hyun-Ah;Kim, Se-Mi;Yoo, Dong-Jin;Kang, Seung-Rae;Lee, Sang-No;Kim, Yong-Hee;Lee, Yong-Bok
    • 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.

Characteristics of Input and Output of Scientific Research (국가별 과학연구 투입과 성과의 특성분석)

  • Park, Hyun-Woo;Kim, Kyung-Ho;Yeo, Woon-Dong
    • Journal of Korea Technology Innovation Society
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    • v.12 no.3
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    • pp.471-498
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    • 2009
  • The ability to judge a country's scientific standing is vital for the governments and businesses that must decide scientific priorities and funding. In this paper, we analyze the output and outcomes from research investment over the recent years, to measure the quality of scientific research on national scales and to set it in an international context. There are many ways to evaluate the quality of scientific research, but few have proved satisfactory. To measure the quantity and quality of science in different nations, we analyzed the numbers of published research papers and their citations. The number of citations per paper is a useful measure of the impact of a nation's research output. Essential at a were acquired from SCI database by Thomson Scientific, which indexes more than 8,000 journals, representing most significant materials in science and engineering. The purpose of this paper is to evaluate and compare the output and outcomes among nations in a variety of viewpoints and criteria. One of the implications in response to the result of analysis is that sustainable economic development in highly competitive world markets requires a direct engagement in the generation of knowledge. Even modest improvement in healthcare, clean water, sanitation, food, and transport need capabilities in engineering, technology, and medicine beyond many countries' reach. Nations exporting natural resources such as gold and oil can import technology and expertise, but only until these resources are exhausted. For them, sustainability should imply investment in alternative agricultural and technological capabilities through improvements in their skills base. A strong science base does not necessarily leat to wealth generation. However, strength in science has additional benefits for individual nations, and for the world as a whole.

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The Moderating Effects of Salesperson's Cultural Intelligence in Intercultural Sales Encounters (문화간 판매접점에서 판매원 문화지능의 조절효과)

  • Kong, Lan-Lan;Kim, Hyoung-Gil;Kim, Yun-Jeong
    • Journal of Distribution Science
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    • v.15 no.12
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    • pp.85-94
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    • 2017
  • Purpose - Owing to economic development and rapid globalization, the number of people traveling abroad has increased dramatically in recent years. For instance, according to data from World Tourism Organization, approximately 1,724 million tourists traveled abroad in 2016. This phenomenon has resulted in a change for domestic markets, as they no longer serve only domestic customers but also serve foreign customers as well. Therefore, intercultural service encounters between services providers and customers from diverse cultural backgrounds are becoming more frequent. Especially in the field of retailing, salesperson's customer oriented selling behavior is particularly important for the successful interactions. However, it is hard to find some factors that can improve salesperson's customer oriented selling behavior in intercultural sales encounters. Research design, data, and methodology - A quantitative survey methodology was utilized to collect data on 312 salespeople at duty-free shops located on Jeju Island, Korea. As a tourism-based region, Jeju Island has attracted a large number of foreign tourists since being designated as an international free city in 2002. Owing to this phenomenon, intercultural sales encounters between salespersons and customers from different cultures have become commonplace. Compared to other salespeople, salespeople working in duty-free shops have more frequent intercultural interactions, as over 90% of their total customers are from foreign countries. Additionally, regular professional training programs for salespeople help cultivate cultural intelligence. Data analysis was conducted using SPSS 20. Results - This paper explores the role of empathy and cultural intelligence in intercultural sales encounters using a theoretical model incorporating the causal relationships between empathy(cognitive empathy and emotional empathy) and customer oriented selling behavior, as well as the moderating effects of cultural intelligence in these relationships. Conclusions - This study is almost the first to explore the influence of empathy and cultural intelligence in intercultural sales encounters. Thus, this study provides a meaningful contribution to the application of empathy and cultural intelligence in the retailing field and will draw the attention of personal distribution practicers and researchers to the importance of empathy and cultural intelligence. Additionally, this study has useful managerial implications for employee selection, training, and development in retailing firms engaged in intercultural sales encounters.

Analysis of the Patients and Treatment of Korean Medicine Hospital after Chemotherapy in Patients with Breast Cancer (유방암 환자의 항암화학요법 후 한방병원 입원치료에 대한 일개 한방병원 환자 특성 및 치료 고찰)

  • Kang, Su-Jin;Kim, Sun-Kyung;Yang, Geum-Jin;Hong, Ka-Kyung;Cho, Han-Baek
    • The Journal of Korean Obstetrics and Gynecology
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    • v.33 no.2
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    • pp.77-89
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    • 2020
  • Objectives: The purpose of this study is to analyse current status and treatment of the Korean medicine hospital after chemotherapy in patients with breast cancer. Methods: We investigated the medical records of 21 patients who admitted to Korean medicine hospital after chemotherapy in patients with breast cacner from March 1, 2017 to December 31, 2019. We searched medical records retrospectively and analyzed current status and treatment of Korean medicine hospital. Results: The average age of 21 participants was 52.81±8.38 years and 40s and 50s accounted for 85.6% of the total. After receiving chemotherapy, the average time to hospitalization was 1.87±3.13days and average hospital stay was 9.78±4.14 days. The subjects were classified as 28.6% of stage I, 52.4% of stage II, 9.5% of stage III, and 9.5% of stage IV. The analysis according to the presence of metastasis was 57.1% without metastasis, 33.3% with axillary lymph node metastasis, and 9.5% with distant metastasis. The main symptoms complained when hospitalized by 21 subjects were nausea (54.2%), fatigue (54.2%), and anorexia (50.8%) in over 50%, pantalgia (47.5%), and insomnia (47.5%), dizziness (44.1%), cold sweating (42.4%), lower extremity pain (40.7%), 37.5~37.9℃ fever (39.0%), headache (37.3%), hot flush (37.3%), pruritus (30.5%) are 30% or more. Korean medicine treatment was performed in 87.4% of all hospitalizations and Gwakhyangjunggi-san-gami was the most administered prescription. Extracts of Korean medicine was performed in 100.0% of all patients and Eunkyo-san was most administered extracts medicine. Acupuncture, moxibustion, and cupping treatments were performed in all 21 study subjects. Other treatments was performed at a frequency of hyperthermia (90.5%), lymph massage (23.8%), air compression therapy (23.8%), and Interference current therapy (19.0%) Conclusion: Korean traditional medicine can be used as a countermeasure for side effects after chemotherapy in breast cancer patients.

Angled Tube Method for Determining Erythrocyte Sedimentation Rate of Cattle (경사관법(傾斜管法)에 의한 우혈액(牛血液)의 적혈구침강율(赤血球沈降率) 측정(測定))

  • Lee, Bang-whan;Shin, Jong-uk
    • Korean Journal of Veterinary Research
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    • v.26 no.1
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    • pp.175-185
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    • 1986
  • The measurement of angled erythrocyte sedimentation rate (ESR), as a replacement for perpendicular ESR, for cattle blood was scrutinized since it has been well known that perpendicular ESR in cattle is too slow to be adopted as an effective clinical test. Samples of blood were taken from 186 Korean native cattle over 2 years old. The results obtained in the experiment were summarized as follows. 1. Average values of perpendicular ESR/24hrs in 15 apparently healthy cattle, as measured by Wintrobe, Westergren and capillary tubes, were $5.8{\pm}2.2$, $11.1{\pm}3.7$ and $10.4{\pm}4.5%$ respectively, which were found to be similar to the values of perpendicular ESR/hr of normal blood of human. 2. The ESR was determined in the tubes held at 90, 75, 60, 45, 30 and 15-degree angles, using 3 types of tubes. For the diagnostic purposes, the best results were obtained from the tubes held at 45-degree angle. 3. The angled ESR values increased as the diameters of the tube-bores decreased. 4. The tube length did not affect the angled ESR(%). 5. The angled ESR values increased with the increased environmental temperature during the ESR measurement. 6. The storage temperature at $5^{\circ}C$, $20^{\circ}C$ and $35^{\circ}C$, of the blood for 24 hours did not affect the angled ESR. 7. Samples of blood were treated with 4 kinds of anticoagulants (heparin, $K_2$-EDTA, double oxalate and sodium citrate) and the ESR was determined at 45-degree angle, using capillary hematocrit tubes. The ESR values were higher in the blood samples treated with sodium citrate than in those treated with other anticoagulants. 8. By using the autologous plasma, the PCV was adjusted to be 5, 10, 20, 30, 40 and 50ml/100ml and the ESR was determined in the capillary hematocrit and Wintrobe tubes held at 45 degrees. In both of the methods the ESRs increased as the values of PCV decreased. The regressions of ESR to PCV in both 45-degree-angled capillary and Wintrobe tubes were curvilinear. For the capillary hematocrit tubes the second degree polynomial $Y=61.9779-2.3533x+0.0228x^2$ (r=0.9999) fits the data. And in the case of Wintrobe tubes the second degree polynomial $Y=27.9767-1.1314x-0.0117x^2$ (r=0.9998) fits the data. 9. The 45-degree angled ESR was determined in the blood of 71 healthy Korean native cows using capillary hematocrit tubes. The average PCV was $35.4{\pm}3.6ml/100ml$. The observed ESR/hr averaged $7.2{\pm}2.7%$, while the corrected ESR/hr to a PCV of 36ml/100ml averaged $6.6{\pm}1.3%$. From these results it was concluded that to obtain the best results the ESR/hr of Korean native cattle should be determined at 45-degree angle at room temperature($20^{\circ}C$) using capillary hematocrit tubes.

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Accuracy of FDG-PET/CT for Detection of Incidental Pre-Malignant and Malignant Colonic Lesions - Correlation with Colonoscopic and Histopathologic Findings

  • Kunawudhi, Anchisa;Wong, Alexandra K;Alkasab, Tarik K;Mahmood, Umar
    • Asian Pacific Journal of Cancer Prevention
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    • v.17 no.8
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    • pp.4143-4147
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    • 2016
  • Purpose: We evaluated all PET/CTs acquired for patients without a primary diagnosis of colorectal cancer, and compared results for those who had subsequent colonoscopy within 6 months, to assess the accuracy of FDG PET/CT for detection of incidental pre-malignant polyps and malignant colon cancers. Materials and Methods: Medical records of 9,545 patients who underwent F-18 FDG PET/CT studies over 3.5 years were retrospectively reviewed. Due to pre-existing diagnosis of colorectal cancer, 818 patients were excluded. Of the remainder, 157 patients had colonoscopy within 6 months (79 males; mean age 61). We divided the colon into 4 regions and compared PET/CT results for each region with colonoscopy and histopathologic findings. True positive lesions included colorectal cancer, villous adenoma, tubulovillous adenoma, tubular adenoma and serrated hyperplastic polyp/hyperplastic polyposis. Results: Of 157 patients, 44 had incidental colonic uptake on PET/CT (28%). Of those, 25 had true positive (TP) uptake, yielding a 48% positive predictive value (PPV); 9% (4/44) were adenocarcinoma. There were 23 false positive (FP) lesions of which 4 were hyperplastic polyp, one was juvenile polyp and 7 were explained by diverticulitis. Fifty eight patients had false negative PET scans but colonoscopy revealed true pre-malignant and malignant pathology, yielding 23% sensitivity. The specificity, negiative predictive value (NPV) and accuracy were 96%, 90% and 87%, respectively. The average SUVmax values of TP, FP and FN lesions were 7.25, 6.11 and 2.76, respectively. There were no significant difference between SUVmax of TP lesions and FP lesions (p>0.95) but significantly higher than in FN lesions (p<0.001). The average size (by histopathology and colonoscopy) of TP lesions was 18.1 mm, statistically different from that of FN lesions which was 5.9 mm (p<0.001). Fifty-one percent of FN lesions were smaller than 5 mm (29/57) and 88% smaller than 10 mm (50/57). Conclusions: The high positive predictive value of incidental focal colonic FDG uptake of 48% for colonic neoplasia suggests that colonoscopy follow-up is warranted with this finding. We observed a low sensitivity of standardly acquired FDG-PET/CT for detecting small polyps, especially those less than 5 mm. Clinician and radiologists should be aware of the high PPV of focal colonic uptake reflecting pre-malignant and malignant lesions, and the need for appropriate follow up.

A Study on the Consignment Quantity and Value of Fishes Circulating in Kunsan Harbor, Jeollabuk-do, Korea (군산항에서 유통되는 어류의 위판 현황)

  • Lee, Chung-Lyul;Choi, Hye-Rim
    • Korean Journal of Ichthyology
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    • v.13 no.4
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    • pp.267-273
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    • 2001
  • This study investigated consignment quantity and value of marine fishes consigned in Kunsan Harbor from 1993 to 1999. The total quantity of fishes consigned over seven years period was 194,531 tons (t), of which 31,632 t (16.3%) in 1994 was the largest, while 25,956 t (13.3%) in 1997 was the smallest. The total consignment value was 367,352,125 thousand won, of which 63,221,365 thousand won (17.2%) in 1996 was the highest, and 38,835,400 thousand won (10.6%) in 1999 the lowest. The group of fish that held the largest weight of consignment sale in Kunsan Harbor was croakers; their consignment quantity was 21,217 t. or 10.9% of all fishes, and their consignment value was 112,768,637 thousand won which is 30.7% of the total value. Fishes consigned in Kunsan Harbor were of great significance in the regional economy, as they comprised 74.7% of the consignment quantity and 76.4% of the consignment value of all marine fishes in Jeollabuk-do, although they came under very low weight as 3.1% of the consignment quantity and 4.2% of the consignment value of the total consignment sales of Korea.

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