• Title/Summary/Keyword: Regulation

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Current Status and Strategies of the Efficacy and Safety Evaluation in Drug Approval Process

  • Park, In-Sook;Park, Chang-Won
    • Proceedings of the PSK Conference
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    • 2003.10a
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    • pp.22-24
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    • 2003
  • This presentation briefly will be introduced on new drug approval process and the review of safety and efficacy of drugs in Korea. First, we will present the regulation related to new drug registration [Regulation of the Efficacy and Safety Evaluation of Drugs, etc (Notification No. 2003-17), Standards for Toxicity Test of Drugs, etc(Notification 1999-61) and GLP Regulation for Nonclinical Laboratory Studies (Notification No. 2000-63)] and the regulation related to clinical trial [Guidelines to Clinical Study Authorization for Drugs (Notification No. 2002-65)] and [Korean Good Clinical Practice(KGCP, Notification No. 1999-67) Regulation]. (omitted)

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The Mediating Effects of Emotional Regulation Abilities on the Relationship Between Mothers' and Fathers' Parenting Behavior and Preschoolers' Externalizing Behavior Problems (부·모의 양육행동과 유아의 외현화 문제행동의 관계에서 정서조절능력의 매개효과)

  • Choi, Jung Eun;Lee, SoYean
    • Korean Journal of Child Studies
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    • v.38 no.1
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    • pp.33-48
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    • 2017
  • Objective: The purpose of this study was to investigate the mediating effects of emotional regulation abilities on the relationship between parenting behavior and preschoolers' externalizing behavior problems. Methods: A survey was conducted with the parents of 166 preschoolers; the children were attending seven different daycare centers in Seoul. Results: The results were as follows: First, emotional regulation abilities fully mediated the relationship between fathers' rejection-restriction parenting behavior and externalizing behavior problems. Second, emotional regulation abilities fully mediated the relationship between mothers' warmth-acceptance, rejection-restriction, and permissive-neglectful parenting behavior and externalizing behavior problems. Third, after controlling for fathers' parenting behavior, emotional regulation abilities fully mediated the relationship between mothers' parenting behavior and externalizing behavior problems. Conclusion: Both parenting behavior and emotional regulation abilities should be considered when attempting to understand the development of preschoolers' externalizing behavior problems. In particular, the results from this study stress the important role of emotional regulation abilities in decreasing externalizing behavior problems and buffering against the influence of negative parenting behavior.

The Relationship between Young Children's Temperament and Emotion Regulation: The Mediation Effect of Mother's Parenting Stress (유아의 기질과 정서조절능력의 관계: 양육스트레스의 매개효과)

  • Park, Ye Rang;Lee, Joo-Yeon
    • Korean Journal of Childcare and Education
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    • v.13 no.4
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    • pp.1-17
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    • 2017
  • Objective: The purpose of this study was to examine the relationships among young children's temperament, emotional regulation, and their mother's parenting stress. This study also analyzed the mediating effect of mother's parenting stress on the relationship between the other two variables. Methods: A total of 304 mothers with young children that lived in Gwangju and Jeollanamdo participated in this study. The data were analyzed using Pearson's correlation coefficient, hierarchical multiple regression analysis, and the Sobel test. Results: The main results are as follows. First, adaptability temperament was positively correlated with children's emotional regulation and negatively correlated with mother's parenting stress. There was no statistically significant relationship between activity temperament and other variables, whereas regularity temperament had only a significant relationship with emotional regulation. Second, it was found that mother's parenting stress partially mediated between children's adaptability temperament and emotional regulation. Conclusion: The results of this study imply that mother's parenting stress is a very important factor on young children's emotional regulation. Also, the present study suggests that children's adaptability temperament and mother's parenting stress should be considered together in order to improve young children's emotional regulation.

Structural Relationships Among Playfulness, Self-regulation and Ego-resilience of Child (유아의 놀이성, 자기조절능력, 자아탄력성 간의 구조적 관계)

  • Kang, Su Kyoung;Kim, Minjeong;Chung, Mi Ra
    • Korean Journal of Child Studies
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    • v.36 no.3
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    • pp.155-174
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    • 2015
  • This study examined the structural relationships among the child's playfulness, self-regulation, and ego-resilience. Through an examination of these relationship, this research aimed to analyze the direct and indirect influences of the child's playfulness on self-regulation and ego-resilience. The participants of this study consisted of 359 children attending kindergartens in the Seoul and Gyeonggi-do area. The sample was analyzed using the SPSS 21.0, AMOS 21.0, and Maximum Likelihood method (ML). The significance of the indirect effects was tested by means of bootstrapping. The results of this study were as follows: (i) the child's playfulness had a direct influence on relational ego-resilience; (ii) the child's playfulness directly affected self-regulation; (iii) the child's self-regulation directly affected relational and aptitudinal ego-resilience; and (iv) the child's playfulness was indirectly influential to relational resilience and resilient competency through self-regulation. The discussion also took into account the specific methods which can be used to enhance the child's playfulness and self-regulation.

A Comparison of Self-Regulation and Sociality between Elementary Scientific Gifted Students and General Students (초등과학영재 학생과 일반학생의 자기조절능력과 사회성의 비교)

  • Lee, Yeo Jin;Choi, Sun Young
    • Journal of Korean Elementary Science Education
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    • v.35 no.4
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    • pp.406-415
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    • 2016
  • The purpose of this study was to compare self-regulation and sociality between elementary scientific gifted students and general students. The subjective students are composed of fifth and sixth grade elementary school students. A survey on self-regulation and sociality had been conducted to 106 general students, 38 gifted class students and 43 students in science educational institute for the gifted. The results of this study were as follows: First, the results of ANOVA test showed that the scientific gifted students were significantly better than general students on all subscales of self-regulation and sociality. Second, the results of correlation analysis indicated that self-regulation and sociality and their subscales were all highly positive relationship on students in science educational institute for the gifted, gifted class students and general students. Third, the results of multiple regression analysis showed that the motivational factor of self-regulation gave the greatest effect to the sociality of students in science educational institute for the gifted, whereas, the cognitive factor of self-regulation gave the greatest effect to the sociality of the general students and gifted class students.

The Effects of Preschoolers' Temperament on Their Emotion Regulation in Different Situations (유아의 기질이 상황에 따른 정서조절에 미치는 영향 -실험, 어린이집, 가정 상황에서 나타나는 정서조절을 중심으로-)

  • Kim, Jung Min;Yi, Soonhyung
    • Korean Journal of Human Ecology
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    • v.23 no.2
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    • pp.193-204
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    • 2014
  • The aims of this study were to examine whether the preschool children's temperament predicted their emotion regulation in different situations. The participants in this study were 148 3-and 5-year-old children recruited from five child-care centers located in a middle-income region of Seoul. Statistical methods used for the data analysis were the frequencies, means, standard deviations, Pearson correlation, multiple regression. The major findings were as follows. The children's temperament contributed to individual differences in emotion regulation. The 3-year-olds' negative affectivity and surgency significantly predicted their mothers' ratings of the children's emotion regulation in everyday situations. The 5-year-olds' effortful control significantly predicted their teachers' ratings of the children's emotion regulation in everyday situations. In addition, the 5-year-olds' negative affectivity, effortful control, and surgency predicted the mothers' ratings of their children's emotion regulation. These results suggest that children's temperament are contributors to the development of their emotion regulation.

The Effects of Preschooler's Self-regulation and Maternal Parenting Behavior on Preschooler's Game Immersion (유아의 자기조절력과 어머니의 양육행동이 남녀 유아의 게임몰입성에 미치는 영향)

  • Kim, Kyoung-Hoe;Chung, Jee-Nha
    • Korean Journal of Human Ecology
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    • v.23 no.2
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    • pp.219-229
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    • 2014
  • The purpose of this study was to investigate the effects of preschooler's self-regulation and maternal parenting behavior on preschooler's game immersion. Subjects were 253 4- to 5-year-old preschoolers(118 boys, 135 girls) and their mothers. Data were analyzed by descriptive statistics, t-test, correlation analysis and stepwise multiple regression analysis. The major findings are summarized as follows: (1) preschooler's game immersion differed from preschooler's gender. Boy preschooler had higher score than girl preschooler in game immersion. (2) Both boy and girl preschooler's game immersion was negatively correlated with preschooler's behavioral regulation and emotional regulation, maternal rational guidance, limit-setting and affection. (3) The most influential factor on boy preschooler's game immersion was behavioral regulation. On the other hand, the most influential factor on girl preschooler's game immersion was emotional regulation, and the next influential factor was maternal affection. Results of this study indicate that self-regulation enhancement program should be developed and mothers should be more affective with their preschoolers in order to prevent preschoolers' game immersion.

Mediating Effect of Self-esteem on the Teacher-Young Child Relationship and Self-regulation Ability of Young Children (교사유아관계와 유아의 자기조절능력 간의 관계에서 자아존중감의 매개효과)

  • Woo, Hee-Jung
    • The Korean Journal of Community Living Science
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    • v.28 no.1
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    • pp.155-165
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    • 2017
  • This study examined the mediating effects of self-esteem on the teacher-young child relationship and self-regulation ability of young children. A survey was conducted on a random sample of 252 young children aged 3-5 years attending a nursery in Gwang-ju, Korea. Based on the data, Person's correlations between variables were analyzed, and hierarchical regression analyses were conducted to identify the direct and indirect effects of the teacher-young child relationship and self-esteem on the self-regulation ability of the young children. First, there were positive correlations among the teacher-young child relationship (intimacy) and self-esteem as well as self-regulation ability. There were negative correlations among the teacher-young child relationship (conflict, dependence) and self-esteem as well as self-regulation ability. Second, self-esteem partially mediated the correlation between the teacher-young child relationship and self-regulation ability. The results suggest that self-esteem may affect the self-regulation ability of young children as a mediating response to the teacher-young child relationship.

The Influence of Maternal Emotional Expression on Preschoolers' Behavior Problems: Dual Mediating Effects of Preschoolers' Emotional Temperament and Emotion Regulation (어머니의 부정적 정서표현이 유아의 문제행동에 미치는 영향 : 유아의 정서성 기질과 정서조절의 순차적 이중매개효과)

  • Lim, Ji Young;Lee, Yoon Jeong
    • Korean Journal of Child Studies
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    • v.38 no.2
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    • pp.51-66
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    • 2017
  • Objective: This study aimed to examine the dual mediating effects of preschoolers' emotional temperament and emotion regulation in the relationship between maternal emotional expression and preschoolers' behavior problems. Methods: The participants included 167 preschoolers and their mothers from Daegu city and Gyeonsang province. The mothers completed questionnaires regarding their own emotional expression, children's temperament, emotion regulation, and behavior problems. Results: The primary results of this study were as follows. First, there were significant correlations among maternal emotional expression, preschoolers' emotional temperament, emotion regulation, and problem behaviors. Second, maternal emotional expression had an indirect effect on preschoolers' behavior problems through preschoolers' emotional temperament and emotion regulation. Conclusion: This study revealed that maternal negative emotional expression and preschoolers' temperament and emotion regulation need to be considered simultaneously to explain the level of preschoolers' behavior problems. More specifically, the results highlight the dual mediating effects of preschoolers' temperament and emotion regulation in the relationship between maternal negative emotional expression and preschoolers' behavior problems.

The Effects of Father Marital Satisfaction on Young Child Emotion Regulation: Mediating Effects of Father Parenting Participation (아버지의 결혼만족도가 유아의 정서조절능력에 미치는 영향: 아버지의 양육참여도의 매개효과)

  • Yoon, Mi Sun;Kim, Misuk
    • Korean Journal of Child Studies
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    • v.37 no.3
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    • pp.111-122
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    • 2016
  • Objective: The purpose of this study was to investigate the association between father marital satisfaction and parenting participation and young child emotion regulation to determine the mediating effects of father marital satisfaction and parenting participation on young child emotion regulation. Methods: This study was conducted with 249 3-, 4-, and 5-year-olds and their fathers at nurseries in Seoul and Gyeonggi. The collected data were analyzed via frequency, average, standard deviation, Pearson's correlation analysis, Baron and Kenny's hierarchical regression analysis, and the Sobel test. Results: First, father marital satisfaction, parenting participation and young child emotion regulation, including the sub-factors of each variable, were all significantly correlated. Second, father parenting participation was found to have a full-mediating effect emotion regulation of the young child. Meanwhile, father parenting participation was found to have a full mediating effect others-regulation of the young child. In addition, father parenting participation was found to have a partial mediating effect on young child self-regulation. Conclusion: These results suggests the need to provide more practical family programs and realistic governmental support to promote father parenting participation.