• Title/Summary/Keyword: Specific process rule

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Critical Essay on the Notice of the Price Adjustment of Generic Drugs (제네릭 의약품 약가 조정 고시에 대한 비판적 고찰)

  • Park, Jeong Yeon
    • The Korean Society of Law and Medicine
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    • v.22 no.1
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    • pp.91-124
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    • 2021
  • In May 2019, the Ministry of Food and Drug Safety revised the "Pharmaceutical Determination and Adjustment Criteria" with the content of differentially calculating the price of generic drugs according to the registration of the drug substance and meeting the requirements for their own bioequivalence test. According to this revised rule, if their own bioequivalence test is not conducted, even the generic drugs that have already been approved would be lowered in price. I wondered whether this system was introduced with sufficient public legal considerations regarding its legislative purposes and means. Therefore, I reviewed the contents of the revised notice based on whether or not it is valid to determine and adjust the price of generic drugs in terms of the legitimacy of legislative purposes and the proportionality principle after introducing the history and background of the rule. First, I raised a question as to whether the purpose of preventing the overrun of generic drugs is indeed legitimate in terms of the legitimacy of the purpose. In order for the revised notice of "reduction of drug prices when the test requirements are not met," to meet the conformity principle, the premise that it is difficult to recognize safety and effectiveness through consignment (joint) bioequivalence test or that these tests are insufficient in safety and efficacy verification than their own test must be established. Nevertheless, it seems that suffficient review has not been carried out. In order to achieve the purpose of securing safety and effectiveness, the focus should be on 'reinforcement of the standards for bioequivalence test and the management of the bioequivalence test itself' rather than whether it is a their own test or a consignment (joint) test. Third, it is contrary to the necessity and substantiality principle that strict standards are uniformly applied to the products that can be considered to have been sufficiently verified for safety and effectiveness after a considerable period of time has passed after the product approval. In many cases, revised administrative legislations quickly enacted and amended in the state of lack of legal review or consensus, while the regulatory effects resulting from it are quite direct and specific to the regulated person. In this respect, I emphasized that the administrative legislative process also requires substantial review and prior control of the regulatory purposes and means, and that the participation of stakeholders in the legislative procedure is to be strengthened.

Memory Organization for a Fuzzy Controller.

  • Jee, K.D.S.;Poluzzi, R.;Russo, B.
    • Proceedings of the Korean Institute of Intelligent Systems Conference
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    • 1993.06a
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    • pp.1041-1043
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    • 1993
  • Fuzzy logic based Control Theory has gained much interest in the industrial world, thanks to its ability to formalize and solve in a very natural way many problems that are very difficult to quantify at an analytical level. This paper shows a solution for treating membership function inside hardware circuits. The proposed hardware structure optimizes the memoried size by using particular form of the vectorial representation. The process of memorizing fuzzy sets, i.e. their membership function, has always been one of the more problematic issues for the hardware implementation, due to the quite large memory space that is needed. To simplify such an implementation, it is commonly [1,2,8,9,10,11] used to limit the membership functions either to those having triangular or trapezoidal shape, or pre-definite shape. These kinds of functions are able to cover a large spectrum of applications with a limited usage of memory, since they can be memorized by specifying very few parameters ( ight, base, critical points, etc.). This however results in a loss of computational power due to computation on the medium points. A solution to this problem is obtained by discretizing the universe of discourse U, i.e. by fixing a finite number of points and memorizing the value of the membership functions on such points [3,10,14,15]. Such a solution provides a satisfying computational speed, a very high precision of definitions and gives the users the opportunity to choose membership functions of any shape. However, a significant memory waste can as well be registered. It is indeed possible that for each of the given fuzzy sets many elements of the universe of discourse have a membership value equal to zero. It has also been noticed that almost in all cases common points among fuzzy sets, i.e. points with non null membership values are very few. More specifically, in many applications, for each element u of U, there exists at most three fuzzy sets for which the membership value is ot null [3,5,6,7,12,13]. Our proposal is based on such hypotheses. Moreover, we use a technique that even though it does not restrict the shapes of membership functions, it reduces strongly the computational time for the membership values and optimizes the function memorization. In figure 1 it is represented a term set whose characteristics are common for fuzzy controllers and to which we will refer in the following. The above term set has a universe of discourse with 128 elements (so to have a good resolution), 8 fuzzy sets that describe the term set, 32 levels of discretization for the membership values. Clearly, the number of bits necessary for the given specifications are 5 for 32 truth levels, 3 for 8 membership functions and 7 for 128 levels of resolution. The memory depth is given by the dimension of the universe of the discourse (128 in our case) and it will be represented by the memory rows. The length of a world of memory is defined by: Length = nem (dm(m)+dm(fm) Where: fm is the maximum number of non null values in every element of the universe of the discourse, dm(m) is the dimension of the values of the membership function m, dm(fm) is the dimension of the word to represent the index of the highest membership function. In our case then Length=24. The memory dimension is therefore 128*24 bits. If we had chosen to memorize all values of the membership functions we would have needed to memorize on each memory row the membership value of each element. Fuzzy sets word dimension is 8*5 bits. Therefore, the dimension of the memory would have been 128*40 bits. Coherently with our hypothesis, in fig. 1 each element of universe of the discourse has a non null membership value on at most three fuzzy sets. Focusing on the elements 32,64,96 of the universe of discourse, they will be memorized as follows: The computation of the rule weights is done by comparing those bits that represent the index of the membership function, with the word of the program memor . The output bus of the Program Memory (μCOD), is given as input a comparator (Combinatory Net). If the index is equal to the bus value then one of the non null weight derives from the rule and it is produced as output, otherwise the output is zero (fig. 2). It is clear, that the memory dimension of the antecedent is in this way reduced since only non null values are memorized. Moreover, the time performance of the system is equivalent to the performance of a system using vectorial memorization of all weights. The dimensioning of the word is influenced by some parameters of the input variable. The most important parameter is the maximum number membership functions (nfm) having a non null value in each element of the universe of discourse. From our study in the field of fuzzy system, we see that typically nfm 3 and there are at most 16 membership function. At any rate, such a value can be increased up to the physical dimensional limit of the antecedent memory. A less important role n the optimization process of the word dimension is played by the number of membership functions defined for each linguistic term. The table below shows the request word dimension as a function of such parameters and compares our proposed method with the method of vectorial memorization[10]. Summing up, the characteristics of our method are: Users are not restricted to membership functions with specific shapes. The number of the fuzzy sets and the resolution of the vertical axis have a very small influence in increasing memory space. Weight computations are done by combinatorial network and therefore the time performance of the system is equivalent to the one of the vectorial method. The number of non null membership values on any element of the universe of discourse is limited. Such a constraint is usually non very restrictive since many controllers obtain a good precision with only three non null weights. The method here briefly described has been adopted by our group in the design of an optimized version of the coprocessor described in [10].

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Recent Advancement in the Differentiation of Tissues and Organs and Regulation of Gene Expression (조직.기관의 분화와 유전자 발현의 조절, 최근의 진보)

  • Harn, Chang-Yawl
    • Korean Journal of Plant Tissue Culture
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    • v.24 no.1
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    • pp.1-35
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    • 1997
  • Fertilized egg, by successive cell divisions, differentiates into different tissues and organs with various structures and functions. Different cells and tissues contain different proteins, products of selective gene expression. Not all the genes in any genomes are equally active, temporal and spatial gene expression being the general rule. Present paper attempts to review the tanscriptional mechanisms or the initiations of transcription from several angles. In some of the organisms the genes in the process of transcription or the genes in the inactive state can be seen under the light microscope. Some bands of Drosophila polytene chromosomes may exhibit a swollen or puff appearance under certain conditions. A puff, unfolded or decondensed form of chromomere, represents sets of intense transcriptional activity or RNA synthesis. The heterochromatic X chromosome whose genes remain inactive in the female mammals can be visualized as a dark staining structure called Barr body, Configuration of chromatin differs between transcribed and nontranscribed chromatin. Modification to the chromatin facilitates RNA synthesis. The movement of large polymerase molecule along the DNA would probably be facilitated if some modifications of the chromatin configuration is effected. Methylation of cytosines in CG sequences is associated with inactive genes. Methylation can play a role in determination of mammalian cells during embryogenesis. Demethylation is necessary for the gene to be expressed during development A histone modification that is also known to be correlated with transcriptional capacity of chromatin is acetylation of the lysine residues of the core histones. Chromatin containing a high level of histone acetylation is very sensitive to DNase 1. For the transcription to occur TBP must first bind to the TATA box. Another TF, TF IIB, then binds to the promoter-TBP complex, facilitating the access of RNA polymerase to the transcription initiation site. As recently as eight years ago researchers assumed that histones were irrelevant to the regulation of gene expression. Histones combine with the DNA to form nucleosome of the chromatin. Histones are vital participant in gene regulation. Histone and basal factors compete for access to TATA box. When DNA is exposed to basal factors before histones are introduced, the basal factors assemble on TATA boxes preventing the access of histones, allowing transcription to occur, for transcription to begin, activator protein at the upstream activation sequence or enhancer must interact with the tail of histone H4 at TATA box and cause the histone role particle to dissociate from the TATA box leading to partial breakup of the histone core particle and allowing the basal factors to bind to the TATA box. New concept of genomic flux in contrast to the old concept of static genome has been developed based on the powerful new molecular techniques. Genomic changes such as repetitive DNAs and transposable elements, it is assumed but not yet proved, may affect some of the developmental patterns that characterize particular cells, tissues, organs, and organisms. In the last decade or so remarkable achievement have been made in the researches of the structures and functions of TFs and the specific target sequences located in promoters or enhancers where these TFs bind. TFs have independent domains that bind DNA and that activate transcription. DNA binding domain of TFs serves to bring the protein into the right location. There are many types of DNA binding domains. Common types of motifs can be found that are responsible for binding to DNA. The motifs are usually quite short and comprise only a small part of the protein structure. Steroid receptors have domains for hormone binding, DNA binding, and activating transcription. The zinc finger motif comprises a DNA binding domain. Leucine zipper consist of a stretch of amino acids with a leucine residue in every seventh position Two proteins form a dimer because they interact by means of leucine zippers on similar α-helical domain. This positions their DNA binding basic domains for interaction with the two halves of a DNA sequence with dyad symmetry of TGACTCA, ACTGAGT.

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A Study on the Efficiency of the North Korean Foreign Economy Arbitration Law (북한 대외경제중재법의 실효성 고찰)

  • Kim, Suk-Chul
    • Journal of Arbitration Studies
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    • v.18 no.1
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    • pp.167-184
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    • 2008
  • The economic cooperation between the South and North Koreas is a very important issue for the unification and economic development of both Koreas. In order to reach a successful economic cooperation, there is a need to coordinate the differences of the two countries before unification. The economic cooperation and the cooperation in other sectors will be followed by the entire unification. It is necessary to prepare a mechanism that could peacefully solve the conflicts and disputes that could arise during the actual process of cooperation, which will secure stable investments and trades. The study on the possibility of introducing the arbitration system as a conflict solving mechanism between the two Koreas is a very important subject, and the basis of this study is on the examination of the arbitration laws of North Korea. Therefore, the study on the efficiency of the North Korean arbitration laws on foreign economy is studying the possibility of a systematical solution to economic conflicts between the South and North Koreas. The problems and possible solutions of the North Korean foreign economy arbitration laws are summarized as follows. First, juridical cooperation system for both South and North courts of justice needs to be set up to smoothly carry out the main procedures. Mutual correspondence and telecommunication needs to be guaranteed, also remittance and the movement of goods shall precede. Second, the free liquidation of businesses by unit and the individual and independent management of wealth of the North Korean economic bodies, organizations and businesses shall precede to independently liquidate wealth and thus make arbitration possible. Third, amendments in the North Korea's foreign economy arbitration law shall be made to some parts of regulations on arbitration agreements and specific contents of written arbitration agreements to avoid conflicts regarding arbitration agreement. Fourth, the members of the North Korean arbitration committee shall impartially manage the committee only without taking the role of arbitrator, and the clause that allows the North Korean committee to nominate the arbitrator shall be erased. In case an agreement regarding the number of arbitrators is not reached, the three arbitrators general rule shall be applied. In case of requests from any of the parties, a third country arbitrator nomination shall be guaranteed. Also, the requested arbitrator by the party shall be nominated with the cooperation of the court. Fifth, the trial in case of non-appearance or written trial shall be added to the North Korean law in to prevent intended negligence or evasion. Sixth, regulations regarding the court's investigation of evidence shall be added to the North Korean law to make fair arbitration possible in case that government power is needed in order to investigate evidence. Seventh, provisions regarding majority decision shall be added in the North Korean law in the impossibility of unanimous decisions, and the certified system in the arbitration committee official text shall be erased to prevent arrogation and assure the power of the decision made by the arbitration government. Eighth, as "the wrong decision approved" reason for cancellation of arbitration in the North Korean law includes the content of the decision made by the arbitrator could lead to uselessness of arbitration, amendment will be necessary to limit it to legitimacy of the arbitration agreement and wrong procedures. It is hoped that this thesis will be of important use in understanding the issues on the workability and the solutions to the South and North Koreas' arbitration that could be presented during the negotiations for the countries' economic cooperation.

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Clinical Features of Acute Nonspecific Mesenteric Lymphadenitis and Factors for Differential Diagnosis with Acute Appendicitis (급성 비특이성 장간막 림프절염의 임상 소견과 급성 충수돌기염과의 감별 인자)

  • Shin, Kyung Hwa;Kim, Gab Cheol;Lee, Jung Kwon;Lee, Young Hwan;Kam, Sin;Hwang, Jin Bok
    • Pediatric Gastroenterology, Hepatology & Nutrition
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    • v.7 no.1
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    • pp.31-39
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    • 2004
  • Purpose: Although acute nonspecific mesenteric lymphadenitis (ANML) is probably common cause of abdominal pain in children, which can be severe enough to be an abdominal emergency, the clinical features of mesenteric lymphadenitis are not clear. Also, a differential diagnosis with acute appendicitis (APPE) is indispensable to avoid serious complications. The clinical features of ANML were determined, and the risk factors for differential diagnosis with APPE were analyzed. Methods: Between November 2000 and May 2001, data from 26 patients (aged 1 to 11 years) with ANML and 21 patients (aged 2 to 13 years) with APPE were reviewed. ANML was defined as a cluster of five or more lymph nodes measuring 10 mm or greater in their longitudinal diameter in the right lower quadrant (RLQ) without an identifiable specific inflammatory process on the ultrasonographic examination. There were risk factors on patient's history, physical examination, and laboratory examination; the location of abdominal pain, abdominal rigidity, rebound tenderness, fever, nocturnal pain, the vomiting intensity, the diarrhea intensity, the symptom duration, and the peripheral blood leukocytes count. Results: Of the 26 ANML patients and 21 APPE patients, abdominal pain was noted on periumbilical (76.9% vs 14.2%), on RLQ (11.5% vs 71.4%), with abdomen rigidity (7.6% vs 80.9%), with rebound tenderness (0.0% vs 76.1%)(p<0.05), in the lower abdomen (11.5% vs 14.2%), and at night (80.8% vs 100.0%) (p>0.05). The clinical symptoms were vomiting (38.4% vs 90.4%), the vomiting intensity ($1.5{\pm}0.7$ [1~3]/day vs $4.5{\pm}2.9$ [1~10]/day), diarrhea (65.3% vs 28.5%) (p<0.05), and fever (61.5% vs 76.2%)(p>0.05). The period to the subsidence of abdominal pain in the ANMA patients was $2.5{\pm}0.5$ (2~3) days. The laboratory data showed a significant difference in the peripheral blood leukocytes count ($8,403{\pm}1,737[5,900{\sim}12,300]/mm^3\;vs\;15,471{\pm}3,749[5,400{\sim}20,800]/mm^3$)(p<0.05). Discriminant analysis between ANML and APPE showed that the independent discriminant factors were a vomiting intensity and the peripheral blood leukocytes count and the discriminant power was 95.7%. Conclusion: The clinical characteristics of ANML were abrupt onset of periumbilical pain without rigidity or rebound tenderness, a mild vomiting intensity, normal peripheral leukocytes count, and relatively short clinical course. If the abdominal pain persist for more than 3 days, and/or the vomiting intensity is more than 3 times/day, and/or the peripheral leukocytes count is over $13,500/mm^3$, abdominal ultrasonography is recommended to rule out APPE.

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An Empirical Study in Relationship between Franchisor's Leadership Behavior Style and Commitment by Focusing Moderating Effect of Franchisee's Self-efficacy (가맹본부의 리더십 행동유형과 가맹사업자의 관계결속에 관한 실증적 연구 - 가맹사업자의 자기효능감의 조절효과를 중심으로 -)

  • Yang, Hoe-Chang;Lee, Young-Chul
    • Journal of Distribution Research
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    • v.15 no.1
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    • pp.49-71
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    • 2010
  • Franchise businesses in South Korea have contributed to economic growth and job creation, and its growth potential remains very high. However, despite such virtues, domestic franchise businesses face many problems such as the instability of franchisor's business structure and weak financial conditions. To solve these problems, the government enacted legislation and strengthened franchise related laws. However, the strengthening of laws regulating franchisors had many side effects that interrupted the development of the franchise business. For example, legal regulations regarding franchisors have had the effect of suppressing the franchisor's leadership activities (e.g. activities such as the ability to advocate the franchisor's policies and strategies to the franchisees, in order to facilitate change and innovation). One of the main goals of the franchise business is to build cooperation between the franchisor and the franchisee for their combined success. However, franchisees can refuse to follow the franchisor's strategies because of the current state of franchise-related law and government policy. The purpose of this study to explore the effects of franchisor's leadership style on franchisee's commitment in a franchise system. We classified leadership styles according to the path-goal theory (House & Mitchell, 1974), and it was hypothesized and tested that the four leadership styles proposed by the path-goal theory (i.e. directive, supportive, participative and achievement-oriented leadership) have different effects on franchisee's commitment. Another purpose of this study to explore the how the level of franchisee's self-efficacy influences both the franchisor's leadership style and franchisee's commitment in a franchise system. Results of the present study are expected to provide important theoretical and practical implications as to the role of franchisor's leadership style, as restricted by government regulations and the franchisee's self-efficacy, which could be needed to improve the quality of the long-term relationship between the franchisor and franchisee. Quoted by Northouse(2007), one problem regarding the investigation of leadership is that there are almost as many different definitions of leadership as there are people who have tried to define it. But despite the multitude of ways in which leadership has been conceptualized, the following components can be identified as central to the phenomenon: (a) leadership is a process, (b) leadership involves influence, (c) leadership occurs in a group context, and (d) leadership involves goal attainment. Based on these components, in this study leadership is defined as a process whereby franchisor's influences a group of franchisee' to achieve a common goal. Focusing on this definition, the path-goal theory is about how leaders motivate subordinates to accomplish designated goals. Drawing heavily from research on what motivates employees, path-goal theory first appeared in the leadership literature in the early 1970s in the works of Evans (1970), House (1971), House and Dessler (1974), and House and Mitchell (1974). The stated goal of this leadership theory is to enhance employee performance and employee satisfaction by focusing on employee motivation. In brief, path-goal theory is designed to explain how leaders can help subordinates along the path to their goals by selecting specific behaviors that are best suited to subordinates' needs and to the situation in which subordinates are working (Northouse, 2007). House & Mitchell(1974) predicted that although many different leadership behaviors could have been selected to be a part of path-goal theory, this approach has so far examined directive, supportive, participative, and achievement-oriented leadership behaviors. And they suggested that leaders may exhibit any or all of these four styles with various subordinates and in different situations. However, due to restrictive government regulations, franchisors are not in a position to change their leadership style to suit their circumstances. In addition, quoted by Northouse(2007), ssubordinate characteristics determine how a leader's behavior is interpreted by subordinates in a given work context. Many researchers have focused on subordinates' needs for affiliation, preferences for structure, desires for control, and self-perceived level of task ability. In this study, we have focused on the self-perceived level of task ability, namely, the franchisee's self-efficacy. According to Bandura (1977), self-efficacy is chiefly defined as the personal attitude of one's ability to accomplish concrete tasks. Therefore, it is not an indicator of one's actual abilities, but an opinion of the extent of how one can use that ability. Thus, the judgment of maintain franchisee's commitment depends on the situation (e.g., government regulation and policy and leadership style of franchisor) and how it affects one's ability to mobilize resources to deal with the task, so even if people possess the same ability, there may be differences in self-efficacy. Figure 1 illustrates the model investigated in this study. In this model, it was hypothesized that leadership styles would affect the franchisee's commitment, and self-efficacy would moderate the relationship between leadership style and franchisee's commitment. Theoretically, quoted by Northouse(2007), the path-goal approach suggests that leaders need to choose a leadership style that best fits the needs of subordinates and the work they are doing. According to House & Mitchell (1974), the theory predicts that a directive style of leadership is best in situations in which subordinates are dogmatic and authoritarian, the task demands are ambiguous, and the organizational rule and procedures are unclear. In these situations, franchisor's directive leadership complements the work by providing guidance and psychological structure for franchisees. For work that is structured, unsatisfying, or frustrating, path-goal theory suggests that leaders should use a supportive style. Franchisor's Supportive leadership offers a sense of human touch for franchisees engaged in mundane, mechanized activity. Franchisor's participative leadership is considered best when a task is ambiguous because participation gives greater clarity to how certain paths lead to certain goals; it helps subordinates learn what actions leads to what outcome. Furthermore, House & Mitchell(1974) predicts that achievement-oriented leadership is most effective in settings in which subordinates are required to perform ambiguous tasks. Marsh and O'Neill (1984) tested the idea that organizational members' anger and decline in performance is caused by deficiencies in their level of effort and found that self-efficacy promotes accomplishment, decreases stress and negative consequences like depression and emotional instability. Based on the extant empirical findings and theoretical reasoning, we posit positive and strong relationships between the franchisor's leadership styles and the franchisee's commitment. Furthermore, the level of franchisee's self-efficacy was thought to maintain their commitment. The questionnaires sent to participants consisted of the following measures; leadership style was assessed using a 20 item 7-point likert scale developed by Indvik (1985), self-efficacy was assessed using a 24 item 6-point likert scale developed by Bandura (1977), and commitment was assessed using a 6 item 5-point likert scale developed by Morgan & Hunt (1994). Questionnaires were distributed to Korean optical franchisees in Seoul. It took about 20 days to complete the data collection. A total number of 140 questionnaires were returned and complete data were available from 137 respondents. Results of multiple regression analyses testing the relationships between the each of the four styles of leadership shown by the franchisor as independent variables and franchisee's commitment as the dependent variable showed that the relationship between supportive leadership style and commitment ($\beta$=.13, p<.001),and the relationship between participative leadership style and commitment ($\beta$=.07, p<.001)were significant. However, when participants divided into high and low self-efficacy groups, results of multiple regression analyses showed that only the relationship between achievement-oriented leadership style and commitment ($\beta$=.14, p<.001) was significant in the high self-efficacy group. In the low self-efficacy group, the relationship between supportive leadership style and commitment ($\beta$=.17, p<.001),and the relationship between participative leadership style and commitment ($\beta$=.10, p<.001) were significant. The study focused on the franchisee's self-efficacy in order to explore the possibility that regulation, originally intended to protect the franchisee, may not be the most effective method to maintain the relationships in a franchise business. The key results of the data analysis regarding the moderating role of self-efficacy between leadership behavior style as proposed by path-goal and commitment theory were as follows. First, this study proposed that franchisor should apply the appropriate type of leadership behavior to strengthen the franchisees commitment because the results demonstrated that supportive and participative leadership styles by the franchisors have a positive influence on the franchisee's level of commitment. Second, it is desirable for franchisor to validate the franchisee's efforts, since the franchisee's characteristics such as self-efficacy had a substantial, positive effect on the franchisee's commitment as well as being a meaningful moderator between leadership and commitment. Third, the results as a whole imply that the government should provide institutional support, namely to put the franchisor in a position to clearly identify the characteristics of their franchisees and provide reasonable means to administer the franchisees to achieve the company's goal.

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