• Journal of Korean Academy of Nursing Administration
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• v.3 no.1
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• pp.51-64
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• 1997

The purpose of the study was to introduce an integrated approach of new Casuistry and specified principlism in resolving ethical problems and studying nursing ethics. In studying clinical ethics and nursing ethics, there is no systematic research method. While nurses often experience ethical dilemmas in practice, much of previous research on nursing ethics has focused merely on describing the existing problems. In addition, ethists presented theoretical analysis and critics rather than providing the specific problems solving strategies. There is a need in clinical situations for an integrated method which can provide the objective description for existing problem situations as well as specific problem solving methods. We inherit two distinct ways of discussing ethical issues. One of these frames these issues in terms of principles, rules, and other general ideas; the other focuses on the specific features of particular kinds of moral cases. In the first way general ethical rules relate to specific moral cases in a theoretical manner, with universal rules serving as "axioms" from which particular moral judgments are deduced as theorems. In the seconds, this relation is frankly practical. with general moral rules serving as "maxims", which can be fully understood only in terms of the paradigmatic cases that define their meaning and force. Theoretical arguments are structured in ways that free them from any dependence on the circumstances of their presentation and ensure them a validity of a kind that is not affected by the practical context of use. In formal arguments particular conclusions are deduced from("entailed by") the initial axioms or universal principles that are the apex of the argument. So the truth or certainty that attaches to those axioms flows downward to the specific instances to be "proved". In the language of formal logic, the axioms are major premises, the facts that specify the present instance are minor premises, and the conclusion to be "proved" is deduced (follows necessarily) from the initial presises. Practical arguments, by contrast, involve a wider range of factors than formal deductions and are read with an eye to their occasion of use. Instead of aiming at strict entailments, they draw on the outcomes of previous experience, carrying over the procedures used to resolve earlier problems and reapply them in new problmatic situations. Practical arguments depend for their power on how closely the present circumstances resemble those of the earlier precedent cases for which this particular type of argument was originally devised. So. in practical arguments, the truths and certitudes established in the precedent cases pass sideways, so as to provide "resolutions" of later problems. In the language of rational analysis, the facts of the present case define the gounds on which any resolution must be based; the general considerations that carried wight in similar situations provide warrants that help settle future cases. So the resolution of any problem holds good presumptively; its strengh depends on the similarities between the present case and the prededents; and its soundness can be challenged (or rebutted) in situations that are recognized ans exceptional. Jonsen & Toulmin (1988), and Jonsen (1991) introduce New Casuistry as a practical method. The oxford English Dictionary defines casuistry quite accurately as "that part of ethics which resolves cases of conscience, applying the general rules of religion and morality to particular instances in which circumstances alter cases or in which there appears to be a conflict of duties." They modified the casuistry of the medieval ages to use in clinical situations which is characterized by "the typology of cases and the analogy as an inference method". A case is the unit of analysis. The structure of case was made with interaction of situation and moral rules. The situation is what surrounds or stands around. The moral rule is the essence of case. The analogy can be objective because "the grounds, the warrants, the theoretical backing, the modal qualifiers" are identified in the cases. The specified principlism was the method that Degrazia (1992) integrated the principlism and the specification introduced by Richardson (1990). In this method, the principle is specified by adding information about limitations of the scope and restricting the range of the principle. This should be substantive qualifications. The integrated method is an combination of the New Casuistry and the specified principlism. For example, the study was "Ethical problems experienced by nurses in the care of terminally ill patients"(Um, 1994). A semi-structured in-depth interview was conducted for fifteen nurses who mainly took care of terminally ill patients. The first stage, twenty one cases were identified as relevant to the topic, and then were classified to four types of problems. For instance, one of these types was the patient's refusal of care. The second stage, the ethical problems in the case were defined, and then the case was analyzed. This was to analyze the reasons, the ethical values, and the related ethical principles in the cases. Then the interpretation was synthetically done by integration of the result of analysis and the situation. The third stage was the ordering phase of the cases, which was done according to the result of the interpretation and the common principles in the cases. The first two stages describe the methodology of new casuistry, and the final stage was for the methodology of the specified principlism. The common principles were the principle of autonomy and the principle of caring. The principle of autonomy was specified; when competent patients refused care, nurse should discontinue the care to respect for the patients' decision. The principle of caring was also specified; when the competent patients refused care, nurses should continue to provide the care in spite of the patients' refusal to preserve their life. These specification may lead the opposite behavior, which emphasizes the importance of nurse's will and intentions to make their decision in the clinical situations.

• Journal of the East Asian Society of Dietary Life
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• v.19 no.2
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• pp.287-294
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• 2009

This study was conducted to evaluate the perception and satisfaction of undergraduates majoring in culinary arts and food service with working and internship abroad. The responses of the participants to 10 questions regarding perception and 13 questions regarding the importance and satisfaction with working and internship abroad were measured on a 5 point Likert scale. The primary results were as follows : 1) The subjects were composed of 50.9% male and 49.1% female students, of which 42.1% were employed and 57.9% experienced an internship abroad. 2) Most students went abroad to gain experience with respect to various foreign cultures in response to recommendations by the western cuisine department. 3) The items "I wish to conduct my affairs continuously"(M=4.21) and "I have good relationships with my colleagues at work"(M=4.11) received the highest points from male and female respondents, respectively. 4) Male students considered "cooperation among divisions"(M=4.11), "language skills"(M=4.38), and "kitchen environment"(M=4.34) to be very important. However, female students believed that "language skills"(M=4.36),"social relationships"(M=4.21), and "wage income"(M=4.18) were most important. Furthermore, male students were most satisfied with "company size" (M=4.28), "kitchen environment"(M=4.21), and "business hours"(M=4.10), while female students were most satisfied with "kitchen environment","incentive"(M=4.14) and "social relationships"(M=4.11).

• Korean Journal of Environment and Ecology
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• v.33 no.6
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• pp.664-676
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• 2019

This study aimed to analyze the bioacoustics and habitat environment of the cicadas inhabiting Taebaeksan National Park, an sub-alpine region in Korea. The mating calls of the cicadas were recorded for approximately 3 months, between July and September of 2018. The recording devices were installed in Daedeoksan valley and Baekcheon valley, inside Taebaeksan National Park, and the sounds were recorded 24 hours a day. In order to obtain the habitat distribution data of the cicadas, the sounds were recorded from 111 spots located in the Taebaeksan National Park trail in August 2018. The daily weather data was obtained from the Taebaek city weather center. The results of the study demonstrated that 5 species of cicadas inhabit Taebaeksan National Park, namely, Leptosemia takanonis, Lyristes intermedius, Kosemia yezoensis, Hyalessa fuscata, and Meimuna opalifera. The time of appearance for L. takanonis was early July to mid-July, and that for L. intermedius, K. yezoensis, H. fuscata, and M. opalifera was mid-July to early September. Analysis of the circadian rhythm revealed that L. intermedius, K. yezoensis, and H. fuscata started producing mating calls between 6:00 and 7:00, which ended at around 19:00 for all the three species. The peak time for producing mating calls was 11:00 for L. intermedius, 12:00 for H. fuscata, and around 13:00 to 14:00 for K. yezoensis. The environmental factors influencing the mating calls of the cicadas inhabiting Taebaeksan National Park were analyzed by logistic regression. The results showed that the probability of producing mating calls increased by 1.192 and 1.279 times in L. intermedius and K. yezoensis, respectively, when the average temperature increased by one degree. When the duration of sunlight increased by one hour, the probability of producing mating calls increased by 4.366 and 2.624 times in L. intermedius and H. fuscata, respectively. Analysis of the interspecific effects revealed that when H. fuscata produced a single mating call, the probability of producing mating calls increased by 14.620 and 2.784 times in L. intermedius and K. yezoensis, respectively. When K. yezoensis and L. intermedius produced mating calls, the probability of producing mating calls in H. fuscata increased by 11.301 and 2.474 times, respectively. L. intermedius and K. yezoensis did not have any effects on each other with respect to the production of mating calls. Analysis of the habitat environment of each species revealed that their habitats were located at altitudes of 1,046 m (780~1,315 m) for L. intermedius, 1,072 m (762~1,361 m) for K. yezoensis, and 976 m (686~1,245 m) for H. fuscata. Unlike H. fuscata, which was found at a low altitude, K. yezoensis and L. intermedius were not found at altitudes lower than 700 m. Analysis of the average aspect of the habitats of each of the cicada species revealed that L. intermedius was found at 166° (125~207°), K. yezoensis was found at 100° (72~128°), and H. fuscata was found at 173° (118~228°). Examination of the distribution of each of the cicada species revealed that they were predominantly distributed in the ridges and slopes located in the southeastern region of Munsubong in Taebaeksan. In summary, L. intermedius and K. yezoensis was found to inhabit higher altitudes in Taebacksan National Park than H. fuscata, which was found throughout the Korean peninsula. Additionally, the main aspect of the cicada habitat was found to be the southeastern region (100~173°), which has good access to daylight.

• Korean Journal of Agricultural Science
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• v.2 no.2
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• pp.341-356
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• 1975

This study was carried out to evaluate three winter active synthetic varieties in a succeeding generations of improvement and polycross progenies of seven genotypes selected at the cool and wet climate of the Western Oregon, in their performance of the polycross progeny test comparing with a control variety, high yielding 'Fawn', at Daejon, Korea. Various plant and leaf characteristics, especially related to photosynthesis, and forage production during the first summer after the establishment were examined. The important conclusions of this study are summarized as follows: 1. The differences of leaf fresh weight among groups and control exhibit genetic differences. The a verage of leaf fresh weight of polycross progeny group was the heaviest and those of winter active synthetic varieties in the succeeding generations of improvement was heavier than variety 'fawn'. Within polycross progeny group the genotypes exhibit genetic differences for leaf dry weight. 2. The leaf area exhibited genetic differences among groups and control. The average of winter active synthetic varieties in a succeeding generation was larger than variety 'Fawn'. Those oi the polycross progeny group was the largest among groups and control. 3. Differences of specific leaf weight(S. L. W.) among and within varieties, genotypes and control were not significant. Further investigation in this respect is necessary through the study of the diurnal change in S. L. W. 4. Differences of leaf width among groups and control exhibited genetic differences. The average leaf width of winter active varieties was larger than those of 'Fawn' variety. And those of polycross progenies of genotypes was the largest. 5. Plant height of 'fawn' variety in the first measurement was higher than those of winter active tall fescue varieties and genotypes. The deviation in plant height among polyeross progenies of seven genotypes gave a great deviation. The regrowth ability of plant height was not different suggesting that this characteristics was about the same among and within groups and control. 6. Plant width, spreading ability, improved through the succeeding generations of the improvement of the winter active synthetic varieties for the first measurement. Differences of plant width at the second measurement among genotypes within polycross progeny group were big enough to show the genetic difference. 7. Tiller number of the winter active synthetic varieties and the average of genotypes in polycross progeny was more than those of the control 'Fawn' in the first measurement. On the second measurement, the differences of tiller number appeared among three synthetic varieties indicating improvement, and there were genetic differences among seven genotypes in polycross progeny test. 8. Forage yield on the first cutting showed a considerble improvement of forage yield in the more advanced generation of synthetic varieties and genetic differences among seven genotypes in the polycross progeny test. The average of polycross progeny group was higher than those of the control or three winter active varieties. It was suggested that we could make a further improvement for the forage yield. 9. The regrowth ability of these winter active varieties and genotypes was about the same capacity at least on the measurement of the regrowth in forage yield and plant height during summer. 10. On the whole, the averages of the polycross progeny group was in the highest value and those of synthetic varieties were higher than the control variety, 'Fawn', for the most characteristics except S. L. W. and the plant height on the first measurement even though the differences were not always significant. And there were genetic differences among seven gentypes in their performance of the polycross progeny. 11. Although it was not always sgnificant, the most advanced winter active variety, '1002', had in the highest value for all plant characteristics and forage yield measurements than the other two varieties, '1001'. 12. The results of the association study among various characteristics were quite agreeable and would be useful in the selection of desirable genotypes for the development of a better variety.

• Journal of Gastric Cancer
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• v.5 no.2
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• pp.89-94
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• 2005

Purpose: Early gastric cancer (EGC) has an excellent prognosis compared to advanced gastric cancer. The 5-year survival rate for EGC now exceeds $90\%$, and EGC is recognized as a curable malignancy. The important prognostic factor in EGC is the status of lymph-node metastasis. Despite conserving surgery being suggested for EGC at present, it is of vital importance to select a surgical method appropriate to each individual case. This retrospective study was undertaken to clarify clinicopathologic features and factors related to lymph-node metastasis in submucosal gastric cancer in order to determine an appropriate therapy. Materials and Methods: This study analyzed the clinicopathologic features for 279 patients with a submucosal gastric carcinoma (Group I) and compared with those of patients with mucosal (Group II) or muscularis proprial gastric carcinoma (Group III). All patients were operated on from 1981 to 1999 at Chonnam University Hospital. There were no statistically significant differences among the groups with respect to age, gender, tumor location, hepatic metastasis, or peritoneal dissemination. Results: Positive lymph node metastasis was found in 47 ($16.8\%$) of the 279 patients with a submucosal gastric carcinoma. The incidence of lymph-node metastasis was significantly higher in patients with a submucosal gastric carcinoma than in patients with a mucosal gastric carcinoma ($16.8\%\;vs.\;3.9\%\;$; P<0.01). Therefore, depth of invasion was a significant factor affecting in lymph-node metastasis. The 5-year survival rates were $88.6\%$ for patients in Group I, $95.2\%$ for patients in Group II, and $72.7\%$ for patients in Group III (P<0.01 for Group I vs. Group II; Group I vs. Group III). In patients with a submucosal gastric carcinoma, the survival rate with positive lymph nodes was significantly poorer than that of patients without lymph-node metastasis ($87.3\%\;vs.\;94.2\%$; P<0.01). Conclusion: Gastrectomy with D2 lymph node dissection is an appropriate operative procedure for patients with a submucosal gastric carcinoma.

• Tuberculosis and Respiratory Diseases
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• v.46 no.2
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• pp.204-214
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• 1999

Background: Resting pulmonary function tests(PFTs) are routinely used in the evaluation of pulmonary impairment/disability. But the significance of the cardiopulmonary exercise test(CPX) in the evaluation of pulmonary impairment is controvertible. Many experts believe that dyspnea, though a necessary part of the assessment, is not a reliable predictor of impairment. Nevertheless, oxygen requirements of an organism at rest are different from at activity or exercising, and a clear relationship between resting PFTs and exercise tolerance has not been established in patients with chronic pulmonary disease. As well, the relationship between resting PFTs and dyspnea is complex. To investigate the relationship of dyspnea, resting PFTs, and CPX, we evaluated the patients of stabilized chronic pulmonary disease with clinical dyspnea rating(baseline dyspnea index, BDI), resting PFTs, and CPX. Method: The 50 patients were divided into two groups: non-severe and severe group on basis of results of resting PFTs(by criteria of ATS), CPX(by criteria of ATS or Ortega), and dyspnea rating(by focal score of BDI). Groups were compared with respect to pulmonary function, indices of CPX, and dyspnea rating. Results: 1. According to the criteria of pulmonary impairment with resting PFTs, $VO_2$max, and focal score of BDI were significantly low in the severe group(p<0.01). According to the criteria of $VO_2$max(ml/kg/min) and $VO_2$max(%), the parameters of resting PFTs, except $FEV_1$ were not significantly different between non-severe and severe(p>0.05). According to focal score($FEV_1$(%), FVC(%), MW(%), $FEV_1/FVC$, and $VO_2$max were significantly lower in the severe group(p<0.01). However, in the more severe dyspneic group(focal score<5), only $VO_2$max(ml/kg/min) and $VO_2$max(%) were low(p<0.01). $FEV_1$(%) was correlated with $VO_2$max(%)(r=0.52;p<0.01), but not predictive of exercise performance. The focal score had the correlation with max WR(%) (r=0.55;p<0.01). Sensitivity and specificity analysis were utilized to compare the different criteria used to evaluate the severity of pulmonary impairment, revealed that the classification would be different according to the criteria used. And focal score for dyspnea showed similar sensitivity and specificity. Conclusion : According to these result, resting PFTs were not superior to rating of dyspnea in prediction of exercise performance in patients with chronic pulmonary diseases and less correlative with focal score for dyspnea than $VO_2$max and max WR. Therefore, if not contraindicated, CPX would be considered to evaluate the severity of pulmonary impairment in patients with chronic pulmonary diseases, including with severe resting PFTs. Current criteria used to evaluate the severity of impairment were insufficient in considering the degree of dyspnea, so new criteria, including the severity of dyspnea, may be necessary.

• Asia pacific journal of information systems
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• v.20 no.3
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• pp.139-166
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• 2010

The supply chain management (SCM) systems have emerged as strong managerial tools for manufacturing firms in enhancing competitive strength. Despite of large investments in the SCM systems, many companies are not fully realizing the promised benefits from the systems. A review of literature on adoption, implementation and success factor of IOS (inter-organization systems), EDI (electronic data interchange) systems, shows that this issue has been examined from multiple theoretic perspectives. And many researchers have attempted to identify the factors which influence the success of system implementation. However, the existing studies have two drawbacks in revealing the determinants of systems implementation success. First, previous researches raise questions as to the appropriateness of research subjects selected. Most SCM systems are operating in the form of private industrial networks, where the participants of the systems consist of two distinct groups: focus companies and vendors. The focus companies are the primary actors in developing and operating the systems, while vendors are passive participants which are connected to the system in order to supply raw materials and parts to the focus companies. Under the circumstance, there are three ways in selecting the research subjects; focus companies only, vendors only, or two parties grouped together. It is hard to find researches that use the focus companies exclusively as the subjects probably due to the insufficient sample size for statistic analysis. Most researches have been conducted using the data collected from both groups. We argue that the SCM success factors cannot be correctly indentified in this case. The focus companies and the vendors are in different positions in many areas regarding the system implementation: firm size, managerial resources, bargaining power, organizational maturity, and etc. There are no obvious reasons to believe that the success factors of the two groups are identical. Grouping the two groups also raises questions on measuring the system success. The benefits from utilizing the systems may not be commonly distributed to the two groups. One group's benefits might be realized at the expenses of the other group considering the situation where vendors participating in SCM systems are under continuous pressures from the focus companies with respect to prices, quality, and delivery time. Therefore, by combining the system outcomes of both groups we cannot measure the system benefits obtained by each group correctly. Second, the measures of system success adopted in the previous researches have shortcoming in measuring the SCM success. User satisfaction, system utilization, and user attitudes toward the systems are most commonly used success measures in the existing studies. These measures have been developed as proxy variables in the studies of decision support systems (DSS) where the contribution of the systems to the organization performance is very difficult to measure. Unlike the DSS, the SCM systems have more specific goals, such as cost saving, inventory reduction, quality improvement, rapid time, and higher customer service. We maintain that more specific measures can be developed instead of proxy variables in order to measure the system benefits correctly. The purpose of this study is to find the determinants of SCM systems success in the perspective of vendor companies. In developing the research model, we have focused on selecting the success factors appropriate for the vendors through reviewing past researches and on developing more accurate success measures. The variables can be classified into following: technological, organizational, and environmental factors on the basis of TOE (Technology-Organization-Environment) framework. The model consists of three independent variables (competition intensity, top management support, and information system maturity), one mediating variable (collaboration), one moderating variable (government support), and a dependent variable (system success). The systems success measures have been developed to reflect the operational benefits of the SCM systems; improvement in planning and analysis capabilities, faster throughput, cost reduction, task integration, and improved product and customer service. The model has been validated using the survey data collected from 122 vendors participating in the SCM systems in Korea. To test for mediation, one should estimate the hierarchical regression analysis on the collaboration. And moderating effect analysis should estimate the moderated multiple regression, examines the effect of the government support. The result shows that information system maturity and top management support are the most important determinants of SCM system success. Supply chain technologies that standardize data formats and enhance information sharing may be adopted by supply chain leader organization because of the influence of focal company in the private industrial networks in order to streamline transactions and improve inter-organization communication. Specially, the need to develop and sustain an information system maturity will provide the focus and purpose to successfully overcome information system obstacles and resistance to innovation diffusion within the supply chain network organization. The support of top management will help focus efforts toward the realization of inter-organizational benefits and lend credibility to functional managers responsible for its implementation. The active involvement, vision, and direction of high level executives provide the impetus needed to sustain the implementation of SCM. The quality of collaboration relationships also is positively related to outcome variable. Collaboration variable is found to have a mediation effect between on influencing factors and implementation success. Higher levels of inter-organizational collaboration behaviors such as shared planning and flexibility in coordinating activities were found to be strongly linked to the vendors trust in the supply chain network. Government support moderates the effect of the IS maturity, competitive intensity, top management support on collaboration and implementation success of SCM. In general, the vendor companies face substantially greater risks in SCM implementation than the larger companies do because of severe constraints on financial and human resources and limited education on SCM systems. Besides resources, Vendors generally lack computer experience and do not have sufficient internal SCM expertise. For these reasons, government supports may establish requirements for firms doing business with the government or provide incentives to adopt, implementation SCM or practices. Government support provides significant improvements in implementation success of SCM when IS maturity, competitive intensity, top management support and collaboration are low. The environmental characteristic of competition intensity has no direct effect on vendor perspective of SCM system success. But, vendors facing above average competition intensity will have a greater need for changing technology. This suggests that companies trying to implement SCM systems should set up compatible supply chain networks and a high-quality collaboration relationship for implementation and performance.

• Clinical and Experimental Reproductive Medicine
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• v.34 no.3
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• pp.189-196
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• 2007

Objectives: The purpose of this study is to investigate the clinical significance of age and basal serum FSH in predicting the outcomes of in vitro fertilization (IVF) in patients with poor-ovarian response. Methods: From January 2000 to December 2004, 85 second IVF cycles of 85 poor-ovarian response patients under the age of 42 with a back-ground of the first IVF cycles at our infertility center and 5 or less oocytes were retrieved and their basal serum FSH levels of 15$\sim$25 mIU/ml were enrolled in this study. Exclusion criteria were patients with a male factor for the etiology of infertility and undergoing genetic diagnosis of embryo such as PGD. Flare-up protocol was used for ovarian stimulation in all cases. Results: When we stratified the study groups by patient's age, the younger age group (age<35, n=35) showed significantly higher implantation rate (19.0% versus 4.0%, p<0.05) and higher ongoing pregnancy rate (100% versus 14.3%, p<0.05) than the older age group (age$\geq$35, n=50). And then, when we stratified the study populations by basal serum FSH level, the lower FSH group (basal serum FSH<20 mIU/ml, n=58) showed significantly higher number of retrieved oocytes (4.6$\pm$0.7 versus 2.2$\pm$0.5, p<0.05) and lower cancellation rate (19.0% versus 55.6%, p<0.05) than higher FSH group (basal serum FSH$\geq$20 mIU/ml, n=27). Conclusions: In conclusion, it was suggested that the patient's age could predict the IVF outcomes in respect to its potency of pregnancy and ongoing pregnancy. Serum basal FSH levels could predict more accurately the ovarian response of cycle, but not clinical outcomes.

• Journal of the Society of Cosmetic Scientists of Korea
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• v.23 no.1
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• pp.5-20
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• 1997

War and poverty depress the consumption of cosmetics, while peace and prosperity encourage their proliferation. With the end of World War II, the US, Europe and Japan witnessed rapid growth of their cosmetic industries. The ending of the Cold War has stimulated the growth of the industry in Eastern Europe. Improved economies, and mass communication are also responsible for the fast growth of the cosmetic industries in many Asian nations. The rapid development of the cosmetic industry in mainland China over the past decade proves that changing economies and political climates can deeply affect the health of our business. In addition to war, economy, political climate and mass communication, factors such as lifestyle, religion, morality and value concepts, can also affect the growth of our industry. Cosmetics are the product of the society. As society and the needs of its people change, cosmetics also evolve with respect to their contents, packaging, distribution, marketing concepts, and emphasis. In many ways, cosmetics mirror our society, reflecting social changes. Until the early 70's, cosmetics in the US were primarily developed for white women. The civil rights movement of the 60's gave birth to ethnic cosmetics, and products designed for African-Americans became popular in the 70's and 80's. The consumerism of the 70's led the FDA to tighten cosmetic regulations, forcing manufacturers to disclose ingredients on their labels. The result was the spread of safety-oriented, "hypoallergenic" cosmetics and more selective use of ingredients. The new ingredient labeling law in Europe is also likely to affect the manner in which development chemists choose ingredients for new products. Environmental pollution, too, can affect cosmetics trends. For example, the concern over ozone depletion in the stratosphere has promoted the consumption of suncare products. Similarly, the popularity of natural cosmetic ingredients, the search of non-animal testing methods, and ecology-conscious cosmetic packaging seen in recent years all reflect the profound influences of our changing world. In the 1980's, a class of efficacy-oriented skin-care products, which the New York Times dubbed "serious" cosmetics, emerged in the US. "Cosmeceuticals" refer to hybrids of cosmetics and pharmaceuticals which have gained importance in the US in the 90's and are quickly spreading world-wide. In spite of regulatory problems, consumer demand and new technologies continue to encourage their development. New classes of cosmeceuticals are emerging to meet the demands of increasingly affluent Asian consumers as we enter the 21st century. as we enter the 21st century.

• Journal of Dairy Science and Biotechnology
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• v.34 no.2
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• pp.99-116
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• 2016

We herein performed animal safety assessment in accordance with Good Laboratory Practice (GLP) regulations with the aim of developing sialic acid from glycomacropeptide (hereafter referred to as "GMP") as an index ingredient and functional component in functional foods. GMP is a type of whey protein derived from milk and a safe food, with multiple functions, such as antiviral activity. A test substance was produced containing 7% (w/w) sialic acid and mostly-hydrolyzed whey protein (hereafter referred to as "7%-GNANA") by enzymatic treatment of substrate GMP. The maximum intake test dose level was selected based on 5,000 mg/kg/day dose set for male NOEL (no-observed-effect-level) and female NOAEL (no-observed-adverse-effect-level) determined by a dose-range finding (DRF) test (GLP Center of Catholic University of Daegu, Report No. 15-NREO-001) that was previously conducted with the same test substance. To evaluate the toxicity of a repeated oral dose of the test substance in connection with the previous DRF study, 1,250, 2,500, and 5,000 mg/kg of the substance were administered by a probe into the stomachs of 6-week-old SPF Sprague-Dawley male and female rats for 90 d. Each test group consisted of 10 male and 10 female rats. To determine the toxicity index, all parameters, such as observation of common signs; measurements of body weight and food consumption; ophthalmic examination; urinalysis, electrolyte, hematological, and serum biochemical examination; measurement of organ weights during autopsy; and visual and histopathological examinations were conducted according to GLP standards. After evaluating the results based on the test toxicity assessment criteria, it was determined that NOAEL of the test substance, 7%-GNANA, was 5,000 mg/kg/day, for both male and female rats. No animal death was noted in any of the test groups, including the control group, during the study period, and there was no significant difference associated with test substance, as compared with the control group, with respect to general symptoms, body weight changes, food consumption, ophthalmic examination, urinalysis, hematological and serum biochemical examination, and electrolyte and blood coagulation tests during the administration period (P<0.05). As assessed by the effects of the test substance on organ weights, food consumption, autopsy, and histopathological safety, change in kidney weight as an indicator of male NOAEL revealed up to 20% kidney weight increase in the high-dose group (5,000 mg/kg/day) compared with the change in the control group. However, it was concluded that this effect of the test substance was minor. In the case of female rats, reduction of food consumption, increase of kidney weight, and decrease of thymus weight were observed in the high-dose group. The kidney weight increased by 10.2% (left) and 8.9% (right) in the high-dose group, with a slight dose-dependency compared with that of the control group. It was observed that the thymus weight decreased by 25.3% in the high-dose group, but it was a minor test substance-associated effect. During the autopsy, botryoid tumor was detected on the ribs of one subject in the high-dose group, but we concluded that the tumor has been caused by a naturally occurring (non-test) substance. Histopathological examination revealed lesions on the kidney, liver, spleen, and other organs in the low-dose test group. Since these lesions were considered a separate phenomenon, or naturally occurring and associated with aging, it was checked whether any target organ showed clear symptoms caused by the test substance. In conclusion, different concentrations of the test substance were fed to rats and, consequently, it was verified that only a minor effect was associated with the test substance in the high-dose (5,000 mg/kg/day) group of both male and female rats, without any other significant effects associated with the test substance. Therefore, it was concluded that NOAEL of 7%-GNANA (product name: Helicobactrol) with male and female rats as test animals was 5,000 mg/kg/day, and it thus was determined that the substance is safe for the ultimate use as an ingredient of health functional foods.