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Bioequivalence of Onfran Tablet to Zofran Tablet (Ondansetron 8mg) (조프란 정(온단세트론 8mg)에 대한 온프란 정의 생물학적동등성)

  • 신인철;홍정욱;박윤영;고현철
    • Biomolecules & Therapeutics
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    • v.11 no.1
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    • pp.58-64
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    • 2003
  • Ondansetron is a potent, highly selective 5-hydroxytryptamin $e_3$(5-H $T_3$) receptor-antagonist, for the management of nausea and vomiting induced by cytotoxic chemotherapy and radiography, and the treatment of post-operative nausea and vomiting. The purpose of the present study was to evaluate the bioequivalence of two ondansetron tablets, Zofran (Glaxo Smithcline Korea Ltd.) and Onfran (Korea United Pharmaceutical Co., Ltd.), according to the guidelines of Korea Food and Drug Administration (KFDA). Eighteen normal male volunteers, 24.39$\pm$1.69 year in age and 69.00$\pm$6.74kg in body weight, were divided into two groups and a randomized 2${\times}$2 cross-over study was employed. After one tablet containing 8mg of ondansetron was orally administered, blood was taken at predetermined time intervals and the concentrations of ondansetron in plasma were determined using HPLC with UV detector. Pharmacokinetic parameters such as AVC, $C_{max}$ and $T_{max}$ were calculated and ANOVA test was utilized for the statistical analysis of the parameters. The results showed that the differences in AUC, $C_{max}$ and T max between two tablets were 5.83%, 5.75% and -5.71%, respectively when calculated against the Zofran, tablet. The powers (1-$\beta$) for AUC, $C_{max}$ and $T_{max}$ were above 90%, above 90% and below 60%, respectively. Minimum detectable differences($\Delta$) at alpha=0.1 and 1-$\beta$=0.8 were less than 20% (e.g., 12.74% and 11.78% for AUC and $C_{max}$ respectively). But minimum detectable differences($\Delta$) at alpha=0.1 and 1-$\beta$=0.8 for $T_{max}$ were more than 20% (e.g., 34.22%). The 90% confidence intervals were within $\pm$20% (e.g., -2.73∼14.39 and -2.16∼13.67 for AUC and $C_{max}$ respectively). But 90% confidence intervals for $T_{max}$ were not within $\pm$20% (e.g., -28.71∼17.28). Another ANOVA test was conducted for logarithmically transformed AUC and $C_{max}$. These results showed that there are no significant difference in AUC and $C_{max}$ between the two formulations: The differences between the formulations in these log transformed parameters were all for less than 20% (e.g., 5.83% and 5.75% for AUC and $C_{max}$ respectively). The 90% confidence intervals for the log transformed data were the acceptance range of log 0.8 to log 1.25 (e.g., log 0.99∼log 1.15 and log 0.98∼log 1.15 for AUC and $C_{max}$ respectively). The major parameters, AUC and $C_{max}$, met the criteria of KFDA for bioequivalence although $T_{max}$ did not meet the criteria of KFDA for bioequivalence, indicating that Onfran tablet is bioequivalent to Zofrm1 tablet.t is bioequivalent to Zofrm1 tablet.m1 tablet.m1 tablet.m1 tablet.

Bioequivalence of Terbinex Tablet to Lamisil Tablet (Terbinafine 125mg) (라미실 정(테르비나핀 125mg)에 대한 터비넥스 정의 생물학적동등성)

  • 고현철;홍정희;신인철
    • Biomolecules & Therapeutics
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    • v.11 no.1
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    • pp.65-71
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    • 2003
  • Terbinafine is a synthetic allylamine that is available in an oral formulation and is used at a dosage of 250mg/day. It is used as an active antifungal agent and inhibits the fungal enzyme squalene epoxidase, which leads to the accumulation of the sterol squalene, which is toxic to the organism. The purpose of the present study was to evaluate the bioequivalence of two terbinafine tablets, Lamisil (Novartis Korea Ltd.) and Terbinex (C-TRI Ltd.), according to the guidelines of Korea Food and Drug Administration (KFDA). Eighteen normal male volunteers, 26.00$\pm$2.57 year in age and 70.51$\pm$9.36 kg in body weight, were divided into two groups and a randomized 2${\times}$2 cross-over study was employed. After one tablet containing 125 mg of terbinafine was orally administered, blood was taken at predetermined time intervals and the concentrations of terbinafine in plasma were determined using HPLC with UV detector. Pharmacokinetic parameters such as AUC, $C_{max}$ and $T_{max}$ were calculated and ANOVA test was utilized for the statistical analysis of the parameters. The results showed that the differences in AUC, $C_{max}$ and $T_{max}$ between two tablets were -4.191%, 5.223% and -25.720%, respectively when calculated against the Lamisil, tablet. The powers (1-$\beta$) for AUC, $C_{max}$ and $T_{max}$ were 81%, 87% and below 60%, respectively. Minimum detectable differences(.il) at alpha=O.1 and 1-/3=0.8 were less than 20% (e.g., 19.72% and 17.77% for AUC and $C_{max}$, respectively). But minimum detectable differences($\Delta$) at alpha=0.1 and 1-$\beta$=0.8 for $T_{max}$ were more than 20% (e.g., 26.25%). The 90% confidence intervals were within $\pm$20% (e.g., -17.440∼9.06 and -6.713∼17.160 for AUC and $C_{max}$ respectively). But 90% confidence intervals for $T_{max}$ were not within $\pm$20% (e.g., -43.346∼8.083). Another ANOVA test was conducted for logarithmically transformed AUC and $C_{max}$. These results showed that there are no significant differences in AUC and $C_{max}$ between the two formulations: The differences between the formulations in these log transformed parameters were all for less than 20% (e.g., -4.19% and 5.22% for AUC and $C_{max}$, respectively). The 90% confidence intervals for the log transformed data were not the acceptance range of log 0.8 to log 1.25 in AUC but the acceptance range of log 0.8 to log 1.25 in $C_{max}$ (e.g., log 1.13∼log 1.50 and log 0.94-log 1.22 for AUC and $C_{max}$ respectively). The major parameters, AUC and $C_{max}$ met the criteria of KFDA for bioequivalence although $T_{max}$ did not meet the criteria of KFDA (1998 year) for bioequivalence, indicating that Onfran tablet is bioequivalent to Zofran tablet. But in another ANOVA test AUC did not meet the criteria of KFDA (2002) for bioequivalence but $C_{max}$ met the criteria of KFDA (2002 year) for bioequivalence.or bioequivalence.equivalence.equivalence.equivalence.

Vesicoureteral Reflux and Renal Scar (방광요관역류와 신반흔)

  • Nam, Hee-Young;Shin, Joon-Heon;Lee, Jun-Ho;Choi, Eun-Na;Park, Hye-Won
    • Childhood Kidney Diseases
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    • v.10 no.2
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    • pp.201-212
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    • 2006
  • Purpose : Vesicoureteral reflux(VUR) is the major risk factor of urinary tract infection(UTI) in children and may result in serious complications such as renal scarring and chronic renal failure. The purpose of this study was to evaluate the relationship between VUR and renal scar formation, the usefulness and correlation of various imaging studies in reflux nephropathy, and the spontaneous resolution of VUR. Methods : We retrospectively reviewed 106 patients with VUR with no accompanying urogenital anomalies in the Department of Pediatrics, Bundang CHA Hospital during the period from Jan. 1996 to Mar. 2005. Ultrasonography and $^{99m}Tc$-dimercaptosuccinic acid(DMSA) scan were performed in the acute period of UTI. Voiding cystourethrography(VCUG) was performed 1 to 3 weeks after treatment with UTI. Follow-up DMSA scan was performed 4 to 6 months after treatment and a follow-up VCUG was performed every 12 months. Results : The mean age at detection of VUR was $13.8{\pm}22.2$ months and the male to female ratio was 2:1. The incidence of renal scarring showed a tendency of direct correlation between severity of VUR(P<0.001) and abnormal findings of renal ultrasonography(P<0.01). 63.2%(24 of 38 renal units) of renal parenchymal defects present in the first DMSA scan disappeared on follow-up DMSA scans. Follow-up DMSA scans detected renal scars in 7(14%) of 50 renal units with ultrasonographically normal kidneys. Meanwhile, ultrasonography did not show parenchymal defects in 7(36.8%) of 19 renal units where renal scarring was demonstrated on a follow-up DMSA scan. The spontaneous resolution rate of VUR was higher(75%) in cases with low grade(I to III) VUR(P<0.01). Conclusions : The presence and severity of VUR and abnormal findings of renal ultrasonography significantly correlated with renal scar formation. DMSA scan was useful in the diagnosis of renal defects. Meanwhile renal ultrasonography was an inadequate method for evaluating renal parenchymal damage. Therefore, follow-up DMSA scans should be performed to detect renal scars even in children with low-grade VUR and normal renal ultrasonography.

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Immune Function-enhancing Effects of Bojungikkitanggami-bang (보중익기탕가미방의 면역기능 증진 효과)

  • Lee Sang Hun;Lee Seung Eon;Lee Si Hyeong;Shin Jo Young
    • Journal of Physiology & Pathology in Korean Medicine
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    • v.18 no.2
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    • pp.528-533
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    • 2004
  • The immune system acts to protect the host from infectious agents that exist in the environment and from other noxious insults. The immune system has two functional divisions: the innate and the acquired. Both components involve various factors such as cytokines. A number of methodologies exist to assess aspects of immune function. There are large inter-individual variations in many immune functions even among the healthy. Genetics, age, gender, smoking habits, habitual levels of exercise, alcohol consumption, diet, stage in the female menstrual cycle, stress, history of infections and vaccinations, and early life experiences are likely to be important contributors to the observed variation. While it is clear that individuals with immune responses significantly below 'normal' are more susceptible to infectious agents and exhibit increased infectious morbidity and mortality, it is not clear how the variation in immune function among healthy individuals relates to variation in susceptibility to infection. Oriental medicine is an important factor contributing to immune competence. The author investigated the immune enhancement effects of Bojungikkitanggami-bang (BITB). The forced swimming test (FST) has been used as a screening model for new immune enhancement agents. In the present study, the author investigated the effects of BITB on FST and blood biochemical parameters related to fatigue, glucose (Glc); blood urea nitrogen (BUN); lactate dehydrogenase (LDH); creatinine; and total protein (TP). The author found that BITB (1 g/kg) significantly reduced the immobility time in the FST compared to the control. In addition, the contents of Glc, LDH, BUN, TP in the blood serum were increased in BITB (1g/kg)-fed group. Also, the author investigated the effects of BITB on the production of cytokines in human T-cell line, MOLT-4 cells. BITB (1 mg/ml) significantly increased the interferon (IFN)-vproduction compared with media control (about 2.2-fold for IFN-γ) at 24 h. However, BITB has not affect the production of IL-2 and IL-4. In addition, BITB increased the protein expression level of IFN-γ in MOLT-4 cells. Thus, BITB may have therapeutic value in generating or enhancing immune function in a clinical setting.

Correlation of Practice and Cognition for Women's Skin Care Behavior (여성의 피부건강행위에 대한 인식도와 실천도의 상관관계분석)

  • Choi Eun-Young;Oh Hyun-Ju;Baek Seung-Hwa
    • Journal of Society of Preventive Korean Medicine
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    • v.4 no.2
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    • pp.273-284
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    • 2000
  • The objective of this study consists on clarifying what factors are influenced upon skin care behavior using fender's Health Promotion Model, widely used to anticipate practices of health care behavior for women with keen interest in skin care and then manifesting their correlations from July 1 to August 22, 1998, on 159 women interested in skin care. A subvariable included practice of skin care behavior and independent variables include general characteristics, health fitness, the level of agreement with the advantages of the perceived skin care behavior, the level of cognition of the necessity for skin care behavior The data collected processed with ANOVA and multiple regression analysis to clarify what factors among other independent variables have the most powerful effects upon skin care. The resultant findings were revealed, as follows : 1. In health care behavior among skin care behavior,'full ingestion of water' represented the highest value by 3.45 points, 2. The testees of this study had for the most part a higher level of cognition for the necessity for skin care behavior than for practice of skin care behavior. The more points they have for cognition of the necessity for skin care behavior, the more points they present for practice of skin care behavior. 3. From the perspective of the relationship between sociometic factors on the testees and their skin care behavior, the higher level married women were on (p<0.05) and the more points they have for economic status, the higher points were reflected . 4. The correlations between the testees' recognition or perception factors and points for practice of skin health state showed the higher points than the group who thought that they did not know their own skin health state (p<0.05). The higher the points of skin care fitness (p<0.0001), the higher the points of self-awareness (p<0.0001) 5. The factors that had the most powerful influence upon cognition and practice of women's skin care behavior were found, with statistical significance, to be adjustable factors such as age, smoking, drinking habit, economic status, etc. and points of cognition of the necessity for skin care behavior.

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One Stage Reconstruction of Skull Exposed by Burn Injury Using a Tissue Expansion Technique

  • Cho, Jae-Young;Jang, Young-Chul;Hur, Gi-Yeun;Koh, Jang-Hyu;Seo, Dong-Kook;Lee, Jong-Wook;Choi, Jai-Koo
    • Archives of Plastic Surgery
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    • v.39 no.2
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    • pp.118-123
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    • 2012
  • Background : An area of the skull exposed by burn injury has been covered by various methods including local flap, skin graft, or free flap surgery. Each method has disadvantages, such as postoperative alopecia or donor site morbidities. Due to the risk of osteomyelitis in the injured skull during the expansion period, tissue expansion was excluded from primary reconstruction. However, successful primary reconstruction was possible in burned skull by tissue expansion. Methods : From January 2000 to 2011, tissue expansion surgery was performed on 10 patients who had sustained electrical burn injuries. In the 3 initial cases, removal of the injured part of the skull and a bone graft was performed. In the latter 7 cases, the injured skull tissue was preserved and covered with a scalp flap directly to obtain natural bone healing and bone remodeling. Results : The mean age of patients was $49.9{\pm}12.2$ years, with 8 male and 2 female. The size of the burn wound was an average of $119.6{\pm}36.7cm^2$. The mean expansion duration was $65.5{\pm}5.6$ days, and the inflation volume was an average of $615{\pm}197.6mL$. Mean defect size was $122.2{\pm}34.9cm^2$. The complications including infection, hematoma, and the exposure of the expander were observed in 4 cases. Nonetheless, only 1 case required revision. Conclusions : Successful coverage was performed by tissue expansion surgery in burned skull primarily and no secondary reconstruction was needed. Although the risks of osteomyelitis during the expansion period were present, constant coverage of the injured skull and active wound treatment helped successful primary reconstruction of burned skull by tissue expansion.

Surgical Treatment for Spontaneous Pneumothoraxl (자연기흉의 수술적 치료 -123례의 분석-)

  • 장인석;김성호
    • Journal of Chest Surgery
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    • v.29 no.4
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    • pp.403-407
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    • 1996
  • One hundred and twenty three patients underwent 137 thoracostomies for spontaneous pneumothorax in the department of Thoracic and Cardiovascular Surgery, Gyeongsang National University from January 1987 to December 1994. There were 118 men and 6 women and average age was )2.4 years. The two most common surgical Indications were recurrent pneumothorax and continuous air leakage. Other indications were visible bullae on simple X-ray, previous contralateral pneumothorax, incomplete expansion of the lung, and bilateral pneumothoraces. Methods of thoracotomy were subaxillary thoracotomy in 82 cases, lateral minithoracotomy in 12 cases and posterolateral thoracotomy in 43 cases. Operation time was 63.0 $\pm$ 30.8, 98.3 $\pm$ 37.9, 186.9 $\pm$ 87.9 minutes respectively, and postoperative chest tube keeping time was 5.2 $\pm$ 4.1 days in subaxillary thoracotomy, 6.2 $\pm$ 5.0 days in minithoracotomy and 10.0 $\pm$ 5.8 days in posterolateral thoracotomy Bullae were present mostly at the apex in spontaneous and tuberculous pneumothorax comparred to the cases of chronic obstructive or emphysematous lung disease, where there were no redilection of presence of bullae (p< 0.01). Operative procedures were wedge resection, bullae obliteration and lobectomy. Postoperative complications were continuous air leakage, bleeding, brachial plexus injury, empyema, and wound infection, but all the complications were cured by the time of discharge. There was no mortality.

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A Study on the Weight Length Index and Dental Caries of Elementary School Students (초등학생들의 체중신장지수(WLI)와 치아우식증에 관한 연구)

  • Lee, Sun-Mi;Kim, Song-Chon
    • Journal of Korean society of Dental Hygiene
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    • v.3 no.1
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    • pp.25-43
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    • 2003
  • In Korea, changes in children's diet patterns accelerate their physical growth and development: frequent snacking has been presumed to be a major cause of increasing dental caries. The present study attempts to clarify the relationship between the physical development of growing children and their tooth decay. For this purpose, 632 six-grade children in 4 elementary school located in Urban(Seoul) and Rural(Po-gok, Yang-In) were classified into three groups based on the Weight Length Index(WLI), known to reflect the nutritional conditions of school-age children, and the relationship was analyzed between each group and the variables considered to be related with dental caries. The result is as follows: The average weight and height of the male is $44.88{\pm}10.89$ kg, $148.49{\pm}7.33$ cm and female is $43.35{\pm}9.60$ kg, $149.23{\pm}6.73$ cm, respectively, which are in the similar level with the Korean Physical Standard. The classification of the children by the WLI reveals a relatively high distribution of over-weighted child ren - 212 persons, 335% of the entire population. The DMFT Index was a little high in the rural area(3.15 teeth in urban and 3.31, in rural). Among the groups of children classified by the WLI, the over-weight group have the highest DMFT index(3.69 teeth). The relationship between the frequency of taking in basic nutrients and the DMFT index is also found: the relationship is not evident in case of the foods containing rich calcium, protein, as well as fruits and vegetables. But, in the protein-rich food, higher frequency of its intake means significantly lower DMFT index in the normal-weight group of the urban children. In case of carbohydrate, higher frequency of its intake means significantly higher DMFT index in all the groups of the rural children. The DMFT index has some correlations with the relevant variables: the index has a positive correlation with the frequency of snacking, and a negative correlation with the economic status. That is, the higher the frequency of snacking is, and the lower the economic status is, the higher the DMFT index may be. In the logistic multiple regression analysis conducted with the presence of DMFT as a dependent variable, only the frequency of tooth brushing is turned to be a variable affecting the presence of either decayed, missing, or filled teeth. Based on the above result, the variables affecting the DMFT index are a time spent on eating, frequency of intake of protein and carbohydrate for a week, frequency of snacking, regular dental check-ups, preventive behaviors for oral health(fluoride gargling, tooth brusing after each meal, proper tooth brushing method). These variables have a relationship with the DMFT index, but the degree is somewhat different between the groups classified either by the region or by the WLI. Therefore, appropriate nutrition management should be conducted according to the individual's nutritional conditions when the services like nutritional education are provided based on the closely-examined characteristics of each target group. And, at the same time, oral health education should be strengthened, and its importance should also be emphasized so that people can pay attention to their own oral health.

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A study on dental professionals' recognition on a system of long-term care insurance for the elderly (노인장기요양보험제도에 관한 치과종사자의 인식도 연구)

  • Ahn, Kwon-Suk;Ji, Min-Gyeong;Min, Hee-Hong
    • Journal of Korean society of Dental Hygiene
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    • v.9 no.1
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    • pp.169-180
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    • 2009
  • This study grasped recognition on a system of long-term care insurance for the elderly targeting dental professionals who are working at dental hospitals and clinics where are located in Daejeon Metropolitan City. It developed and utilized materials available for educating the care staff in a system of long-term care insurance for the elderly and the dental professionals who participate in the oral hygiene service. It carried out the effective duty performance for the elderly in a situation of long-term care protection. Thus, the purpose of this study was to contribute to the early settlement in a system of long-term care insurance for the elderly. The following conclusions were obtained as a result of having carried out self-administered questionnaire research targeting 238 people from August 1 to August 30 in 2008. 1. In the general characteristics of the research subject, the present working place was indicated to be 22.7% for dental hospital, 71.8% for dental clinic, and 5.5% for others. As for the main duty field, the medical treatment & cooperative duty was indicated to be the highest with 61.8%, and was statistically significant(p=0.000). 2. The necessity for a system of long-term care insurance for the elderly was indicated to be 77.7% for 'necessary' and 1.7% for 'unnecessary,' and was statistically significant(p=0.016). 3. In the item of dividing the service of long-term care insurance for the elderly, the dental hygienists showed higher recognition than non-dental hygienists, and indicated significant difference(p=0.010). 4. As for recognition on a system of long-term care insurance for the elderly in dental professionals who responded as saying of 'knowing name and contents' about a system of long-term care insurance for the elderly, the recognition level was high in recognition of subjects' age(p=0.000), division in services(p=0.012), contents in at-home care service(p=0.000), execution in oral-hygiene service(p=0.004), procedure of using the long-term care insurance for the elderly(p=0.016), item of judging grade of long-term care insurance for the elderly(p=0.013), medical charge by service according to judging grade of long-term care insurance for the elderly(p=0.015), burden of cost for a system of long-term care insurance for the elderly(p=0.011), qualification of care staff(p=0.002), and contents of oral-hygiene service(p=0.027), and showed significant difference. 5. The service of long-term care insurance for the elderly and the oral-hygiene service indicated the statistically significant correlation. Accordingly, all of dental professionals need to make a desperate effort to improve dental professionals' knowledge on a system of long-term care insurance for the elderly enough to be required a system of long-term care insurance for the elderly. The more systematic and standardized professional education and materials are thought to be needed to be developed aiming at the success in oral-hygiene service within a system of long-term care insurance for the elderly, by strengthening professionalism in dentists and dental hygienists.

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Consumers' Subjective Risk Perceptions of Tab Water and Stated Preferences for Safe Drinking Water (소비자들의 수돗물에 대한 주관적 위험인지와 안전한 음용수에 대한 진술선호 분석)

  • Eom, Young Sook
    • Environmental and Resource Economics Review
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    • v.15 no.2
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    • pp.147-175
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    • 2006
  • This paper attempts to incorporate three important factors-perceptions, behavior and valuation-in analysing consumers' responses to health risks from environmental pollutants. Using a survey sample of 500 consumers in the Chonbuk province area, this paper empirically investigated determinants of risk perceptions from using tap water as drinking water. Most consumers were considerably concerned about health risks from drinking tap water. Moreover, those subjective concerns were not random, but were systematically related to individuals' demographic variables such as age, gender, and family size. Those subjective beliefs also influenced respondents' purchase intentions on safer water bottles, in response to a contingent behavior question of presenting two types of water bottles. The technical risk information provided in the survey had significant effects on purchase intentions only when it was interacted with respondents' actual averting practice. In addition, the sample selection effects were present by eliminating respondents who decided not to purchase either of two types of water bottles. The potential selection bias had impacts on the coefficients of the price difference variable, and subsequently the estimates of the price increments for health risk reductions.

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