• Title/Summary/Keyword: Statistical Analysis Method

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Development of Aceclofenac Soft Capsule (Clanza S Soft Capsule) (아세클로페낙 연질캡슐(클란자 에스 연질캡슐)의 개발)

  • Yong, Chul-Soon;Lee, Kyung-Hee;Choi, Jin-Suck;Park, Byung-Joo;Jung, Se-Hyun;Kim, Yong-Il;Park, Sang-Man;Bae, Myung-Soo;Kim, Gui-Ja;Gill, Young-Sig;Yu, Chang-Hun;Kang, Sung-Lyoung;Yoo, Bong-Kyu;Rhee, Jong-Dal;Choi, Han-Gon
    • Journal of Pharmaceutical Investigation
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    • v.34 no.1
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    • pp.49-55
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    • 2004
  • To develop a aceclofenac soft capsule, four preparations with various solubilizers were prepared and their dissolution test was carried out. Among four preparations tested, a preparation with ethanolamine was selected as a formula of aceclofenac soft capsule (Clanza $S^{TM}$), since it showed the fastεst dissolution rate. Bioequivalence of aceclofenac tablet, $Airtal^{TM}$ (Dae-Woong Pharmaceutical Co., Ltd.) and aceclofenac soft capsule, Clanza $S^{TM}$ (Korea United Pharmaceutical Co., Ltd.) was evaluated according to the guideline of KA Fourteen normal male volunteers (age 20 - 25 years old) were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After oral administration of one tablet or capsule containing 100 mg of aceclofenac, blood was taken at predetermined time intervals and the concentration of aceclofenac in plasma was determined with an HPLC method under UV detector The pharmacokinetic parameters ($C_{max}$ and $AUC_t$) were calculated and ANOVA was utilized for the statistical analysis of parameters using logarithmetically transformed $AUC_t$, $C_{max}$ and $T_{max}$. The results showed that the differences in $AUC_t$, $C_{max}$ and $T_{max}$ between Aral tablet and Clanza soft capsule were 2.89%, 0.18% and 43.0%, respectively. There were no sequence effects between two formulations in these parameters. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of log(0.8) to log(15) (e.g. log(0.81) -log(1.23) ad log(0.89) -log(1.4)) fo $AUC_t$ and $C_{max}$, respectively. Thus, the criteria of the KFDA guidelines for the equivalence was satisfied, indicating that Clanza $S^{TM}$ soft capsule is bioequivalent to$Airtal^{TM}$ tablet.

Bioequivalence of Burophil Capsule to Surfolase Capsule (Acebrophylline 100 mg) (설포라제 캡슐(아세브로필린 100 mg)에 대한 부로필 캡슐의 생물학적 동등성)

  • Cho, Hea-Young;Park, Eun-Ja;Kang, Hyun-Ah;Kim, Se-Mi;Park, Chan-Ho;Oh, In-Joon;Lim, Dong-Koo;Lee, Myung-Hee;Lee, Yong-Bok
    • Journal of Pharmaceutical Investigation
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    • v.35 no.3
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    • pp.179-185
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    • 2005
  • Acebrophylline is a compound produced by salifying ambroxol with theophylline-7 -acetic acid. After acebrophylline administration, the salt splits into these two components which feature a peculiar pharmacokinetic behavior, an adequate ambroxol and a low theophylline-7-acetic acid serum levels. The purpose of the present study was to evaluate the bioequivalence of two acebrophylline capsules, Surfolase (Hyundai Pharm. lnd. Co., Ltd.) and Burophil (Kuhnil Pharm. Co., Ltd.), according to the guidelines of the Korea Food and Drug Administration (KFDA). The release of ambroxol from the two acebrophylline formulations in vitro was tested using KP VIII Apparatus II method with various dissolution media (pH 1.2, 4.0, 6.8 buffer solution and water). Twenty eight healthy male subjects, $23.25{\pm}1.43$ years in age and $64.82{\pm}6.77$ kg in body weight, were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After two capsules containing 100 mg as acebrophylline were orally administered, blood was taken at predetermined time intervals and the concentrations of ambroxol in serum were determined using HPLC with electrochemical detector (ECD). The dissolution profiles of two formulations were similar at all dissolution media. In addition, the pharmacokinetic parameters such as $AUC_t$, $C_{max}$ and $T_{max}$ were calculated and ANOVA test was utilized for the statistical analysis of the parameters using logarithmically transformed $AUC_t$, $C_{max}$ and untransformed $T_{max}$. The results showed that the differences between two formulations based on the reference drug Surfolase, were -1.64, -3.33 and -0.92% for $AUC_t$, $C_{max}$ and $T_{max}$, respectively. There were no sequence effects between two formulations in these parameters. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of log 0.8 to log 1.25 $(e.g., \;log\;0.93{\sim}log\;1.05\;and\;log\;0.88{\sim}log\;1.05$ for $AUC_t$, and $C_{max}$, respectively). Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating Burophil capsule was bioequivalent to Surfolase capsule.

Bioequivalence of SCD Zaltoprofen Tablet to Soleton® Tablet (Zaltoprofen 80 mg) (솔레톤 정(잘토프로펜 80 mg)에 대한 삼천당잘토프로펜 정의 생물학적동등성)

  • Kang, Hyun-Ah;Park, Sun-Ae;Kim, Dong-Ho;Kim, Hwan-Ho;Yun, Hwa;Kim, Kyng-Ran;Yoo, Hee-Doo;Park, Eun-Ja;Cho, Hye-Young;Lee, Yong-Bok
    • Journal of Pharmaceutical Investigation
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    • v.36 no.3
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    • pp.209-215
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    • 2006
  • Zaltoprofen, (2-(10,11-dihydro-10-oxodibenzo[b,f]thiepin-2-yl)propionic acid) is an NSAID with powerful anti-inflammatory effects as well as an analgesic action on inflammatory pain. The purpose of the present study was to evaluate the bioequivalence of two zaltoprofen tablets, $Soleton^{\circledR}$ (CJ Corp.) and SCD Zaltoprofen (Samchundang Pharmaceutical Co., Ltd.), according to the guidelines of the Korea Food and Drug Administration (KFDA). The release of zaltoprofen from the two zatoprofen formulations in vitro was tested using KP Vlll Apparatus ll method with various dissolution media. Twenty six healthy male subjects, $23.2{\pm}2.26$ years in age and$64.7{\pm}8.08$ kg in body weight, were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After a single tablet containing 80 mg as zaltoprofen was orally administered, blood samples were taken at predetermined time intervals and the concentrations of zaltoprofen in serum were determined using HPLC with UV detector. The dissolution profiles of two formulations were similar in all tested dissolution media. The pharmacokinetic parameters such as $AUC_t$, $C_{max}$ and $T_{max}$ were calculated, and ANOVA test was utilized for the statistical analysis of the parameters using logarithmically transformed $AUC_t$, $C_{max}$ and untransformed $T_{max}$. The results showed that the differences between two formulations based on the reference drug, $Soleton^{\circledR}$ were 6.33, 5.91 and 17.7% for $AUC_t$, $C_{max}$ and untransformed $T_{max}$, respectively. There were no sequence effects between two formulations in these parameters. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of log 0.8 to log 1.25 (e.g.,log $1.01{\sim}1og\;1.11$ and log $0.928{\sim}1og\;1.18$ for $AUC_t$ and $C_{max}$, respectively). Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating SCD Zaltoprofen tablet was bioequivalent to $Soleton^{\circledR}$ tablet.

The Survey on Pesticide Residues in Vegetables Collected In Seoul (서울지역 유통 채소류의 잔류농약 조사)

  • Jang, Mi-Ra;Moon, Hyun-Kyung;Kim, Tae-Rang;Yuk, Dong-Hyun;Kim, Eun-Hee;Hong, Chae-Kyu;Choi, Chae-Man;Hwang, In-Sook;Kim, Jung-Hun;Kim, Moo-Sang
    • The Korean Journal of Pesticide Science
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    • v.15 no.2
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    • pp.114-124
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    • 2011
  • The characteristics of pesticide residues by multiresidue analysis method using GC, HPLC and GC-MSD were examined for 18,069 numbers of 91 kinds of vegetables in Seoul from 2007 to 2009. Detection rates of pesticide residues were 11.2% in 2007, 8.5% in 2008 and 12.0% in 2009, respectively, and the excess rates of Maximum Residue Limits (MRLs) showed a declining tendency as 4.6% in 2007, 2.8% in 2008 and 2.1% in 2009, respectively. The pesticides exceeding MRLs were 43 ingredients in 2007, 30 ingredients in 2008 and 36 ingredients in 2009, respectively. The frequencies of pesticides exceeding MRLs were 71 of azoxystrobin in 2007, 29 of procymidone in 2008, 24 of endosulfan in 2009, respectively. The excess rate of mustard green for MRLs in comparison with sample numbers was the highest among vegetables analyzed more than 10 cases each year. As a result of comparing annually pesticide residues about pesticide ingredients showed high frequency rates for pesticide detection, there was a statistical significance for the detection quantities of diazinon, endosulfan, paclobutrazol and procymidone.

Effects of Contrast Improvement on High Voltage Rectification Type of X-ray Diagnostic Apparatus (X선 진단장치의 고압정류방식이 대조도 향상에 미치는 영향)

  • Lee, Hoo-Min;Yoon, Joon;Kim, Hyun-Ju
    • Journal of radiological science and technology
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    • v.37 no.3
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    • pp.187-193
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    • 2014
  • The purpose of this study was to analyze the effect on the selectivity on of high-voltage rectification device that measured the performance of the grid, and the contrast improvement ability (K factor) by measuring the scattered radiation content of the transmitted X-rays. The scattered radiation generated when the X-ray flux comes from the diagnostic X-ray generator that passes through an object. Targeting four different rectifications of X-ray generators, the mean value of the tube voltage and the tube current was measured in order to maximize the accuracy of the generating power dose within the same exposure condition. Using fluorescence meter, the content of the scattered rays that are transmitted through the acrylic was measured depending on the grid usage. When grid is not used, the content of the scattered rays was the lowest (34.158%) with the single-phase rectifier, was increased with the inverter rectifier (37.043%) and the three-phase 24-peak rectification method (37.447%). The difference of the scattered radiation content of each device was significant from the lowest 0.404% to the highest 3.289% while using 8:1 grid, the content of the scattered ray was the lowest with the single content of the scattered ray was the lowest with the single-phase rectifier (18.258%), was increased with the rectifier (25.502%) and the 24-peaks rectification (24.217%). Furthermore, there was difference up to content 7.244% to the lowest content 1.285% within three-phase 24-peaks rectification, inverter rectifications, and single-phase rectifier depending on the selectivity of the grid. Drawn from the statistical analysis, there was a similar relationship between the contrast improvement factor and the K factor. As a result, the grid selectivity and the contrast were increased within the single-phase rectifier rather than the constant voltage rectifier.

End-use analysis of household water by metering (가정용수의 용도별 사용량 조사 및 원단위 분석)

  • Kim, Hwa-Soo;Lee, Doo-Jin;Kim, Ju-Whan;Kim, Jung-Hyun;Jung, Kwan-Soo
    • Proceedings of the Korea Water Resources Association Conference
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    • 2008.05a
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    • pp.869-877
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    • 2008
  • The purpose of this study is to investigate the trends and patterns of variou kind of water uses in a household by metering in Korea. Water use components are classified by toilet, washbowl, bathing, laundry, kitchen, etc. Flow meters are installed in 146 household selected by sampling in all around Korea. The data are gathered by web-based data collection system from the year 2002 to 2006, considering pre-investigated data such as occupation, revenue, family members, housing types, age, floor area, water saving devices, education, etc. Reliable data are selected by upper fence method for each observed water use component and statistical characteristics are estimated for each residential type to determine liter per capita per day. Estimated domestic per capita day show an indoor water use with the range from $150{\ell}pcd$ to $169{\ell}pcd$ for each housing type as the order of high rise apartment, multi-house, and single house. As the order of consuming amount among water use components, it is investigated that toilet($38.5{\ell}pcd$) is the first, and the second is laundry water($30.8{\ell}pcd$), the third is kitchen($28.4{\ell}pcd$), the fourth is bathtub($24.7{\ell}pcd$), the next is washbowl($15.4{\ell}pcd$). The results are compared with water uses in U.K. and U.S. As life style has been changed into western style, pattern of water use in Korea is tend to be similar with the U.S. water use pattern. Compared with the surveying results by Bradley, on 1985. Thirty liter of total use increased with the advancement of economic level, and a little change of water use pattern can be found. Especially, toilet water take almost half part of total water use and laundry water shows lowest as 11% in surveying at the year of 1985. But, this study shows that 39 liter, 28% of toilet water, has been decreased by the spread of saving devices and campaign. It is supposed that the spread large sized laundry machine make by-hand laundry has been decreased and water use increased. Unit water amount of each end-use in household can be applied to design factor for water and wastewater facilities, and it play a role as information in establishing water demand forecasting and conservation policy.

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A Web-based 'Patterns of Care Study' System for Clinical Radiation Oncology in Korea: Development, Launching, and Characteristics (우리나라 임상방사선종양을 위한 웹 기반 PCS 시스템의 개발과 특성)

  • Kim, Il Han;Chie, Eui Kyu;Oh, Do Hoon;Suh Chang-Ok;Kim, Jong Hoon;Ahn, Yong Chan;Hur, Won-Joo;Chung, Woong Ki;Choi, Doo Ho;Lee, Jae Won
    • Radiation Oncology Journal
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    • v.21 no.4
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    • pp.291-298
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    • 2003
  • Purpose: We report upon a web-based system for Patterns of Care Study (PCS) devised for Korean radiation oncology. This PCS was designed to establish standard tools for clinical quality assurance, to determine basic parameters for radiation oncology processes, to offer a solid system for cooperative clinical studies and a useful standard database for comparisons with other national databases. Materials and Methods: The system consisted of a main server with two back-ups in other locations. The program uses a Linux operating system and a MySQL database. Cancers with high frequencies in radiotherapy departments in Korea from 1998 to 1999 were chosen to have a developmental priority. Results: The web-based clinical PCS .system for radiotherapy in www.pcs.re.kr was developed in early 2003 for cancers of the breast, rectum, esophagus, larynx and lung, and for brain metastasis. The total number of PCS study items exceeded one thousand. Our PCS system features user-friendliness, double entry checking, data security, encryption, hard disc mirroring, double back-up, and statistical analysis. Alphanumeric data can be input as well as image data. In addition, programs were constructed for IRB submission, random sampling of data, and departmental structure. Conclusion: For the first time in the field of PCS, we have developed a web-based system and associated working programs. With this system, we can gather sample data in a short period and thus save, cost, effort and time. Data audits should be peformed to validate input data. We propose that this system should be considered as a standard method for PCS or similar types of data collection systems.

A Computed Tomography-Based Anatomic Comparison of Three Different Types of C7 Posterior Fixation Techniques : Pedicle, Intralaminar, and Lateral Mass Screws

  • Jang, Woo-Young;Kim, Il-Sup;Lee, Ho-Jin;Sung, Jae-Hoon;Lee, Sang-Won;Hong, Jae-Taek
    • Journal of Korean Neurosurgical Society
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    • v.50 no.3
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    • pp.166-172
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    • 2011
  • Objective : The intralaminar screw (ILS) fixation technique offers an alternative to pedicle screw (PS) and lateral mass screw (LMS) fixation in the C7 spine. Although cadaveric studies have described the anatomy of the pedicles, laminae, and lateral masses at C7, 3-dimensional computed tomography (CT) imaging is the modality of choice for pre-surgical planning. In this study, the goal was to determine the anatomical parameter and optimal screw trajectory for ILS placement at C7, and to compare this information to PS and LMS placement in the C7 spine as determined by CT evaluation. Methods : A total of 120 patients (60 men and 60 women) with an average age of $51.7{\pm}13.6$ years were selected by retrospective review of a trauma registry database over a 2-year period. Patients were included in the study if they were older than 15 years of age, had standardized axial bone-window CT imaging at C7, and had no evidence of spinal trauma. For each lamina and pedicle, width (outer cortical and inner cancellous), maximal screw length, and optimal screw trajectory were measured, and the maximal screw length of the lateral mass were measured using m-view 5.4 software. Statistical analysis was performed using Student's t-test. Results : At C7, the maximal PS length was significantly greater than the ILS and LMS length (PS, $33.9{\pm}3.1$ mm; ILS, $30.8{\pm}3.1$ mm; LMS, $10.6{\pm}1.3$; p<0.01). When the outer cortical and inner cancellous width was compared between the pedicle and lamina, the mean pedicle outer cortical width at C7 was wider than the lamina by an average of 0.6 mm (pedicle, $6.8{\pm}1.2$ mm; lamina, $6.2{\pm}1.2$ mm; p<0.01). At C7, 95.8% of the laminae measured accepted a 4.0-mm screw with a 1.0 mm of clearance, compared with 99.2% of pedicle. Of the laminae measured, 99.2% accepted a 3.5-mm screw with a 1.0 mm clearance, compared with 100% of the pedicle. When the outer cortical and inner cancellous height was compared between pedicle and lamina, the mean lamina outer cortical height at C7 was wider than the pedicle by an average of 9.9 mm (lamina, $18.6{\pm}2.0$ mm; pedicle, $8.7{\pm}1.3$ mm; p<0.01). The ideal screw trajectory at C7 was also measured ($47.8{\pm}4.8^{\circ}$ for ILS and $35.1{\pm}8.1^{\circ}$ for PS). Conclusion : Although pedicle screw fixation is the most ideal instrumentation method for C7 fixation with respect to length and cortical diameter, anatomical aspect of C7 lamina is affordable to place screw. Therefore, the C7 intralaminar screw could be an alternative fixation technique with few anatomic limitations in the cases when C7 pedicle screw fixation is not favorable. However, anatomical variations in the length and width must be considered when placing an intralaminar or pedicle screw at C7.

Assessment of Breast Cancer Knowledge among Health Workers in Bangui, Central African Republic: a Cross-sectional study

  • Balekouzou, Augustin;Yin, Ping;Pamatika, Christian Maucler;Nambei, Sylvain Wilfrid;Djeintote, Marceline;Doromandji, Eric;Gouaye, Andre Richard;Yamba, Pascal Gastien;Guessy, Elysee Ephraim;Ba-Mpoutou, Bertrand;Mandjiza, Dieubeni Rawago;Shu, Chang;Yin, Minghui;Fu, Zhen;Qing, Tingting;Yan, Mingming;Mella, Grace;Koffi, Boniface
    • Asian Pacific Journal of Cancer Prevention
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    • v.17 no.8
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    • pp.3769-3776
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    • 2016
  • Background: Breast cancer is the leading cause of cancer deaths among women worldwide. High breast cancer mortality has been attributed to lack of public awareness of the disease. Little is known about the level of knowledge of breast cancer in Central African Republic. This study aimed to investigate the knowledge of health professionals on breast cancer. Materials and Methods: This cross-sectional study was conducted among 158 health professionals (27 medical; 131 paramedical) in 17 hospitals in Bangui using a self-administered questionnaire. Descriptive statistical analysis, Person's ${\chi}^2$ test and ANOVA were applied to examine associations between variables with p < 0.05 being considered significant. Results: Data analyzed using SPSS version 20 indicates that average knowledge about breast cancer perception of the entire population was 47.6%, diagnosis method 45.5%, treatment 34.3% and risk factors 23.8%. Most respondents (65.8%) agreed that breast cancer is important in Central African Republic and that family history is a risk factor (44.3%). Clinical assessments and mammography were considered most suitable diagnostic methods, and surgery as the best treatment. The knowledge level was significantly higher among medical than paramedical staff with regard to risk factors, diagnosis and treatment. However the trainee group had very high significant differences of knowledge compared with all other groups. Conclusions: There is a very urgent need to update the various training programs for these professionals, with recommendations of retraining. Health authorities must create suitable structures for the overall management of cancer observed as a serious public health problem.

Relationship of Maternal Perception of the Infant Temperament and Confidence and Satisfaction of Maternal Role (어머니가 지각한 영아기질과 어머니 역할수행에 대한 자신감 및 만족도의 관계)

  • Lee Young-Eun;Kang Yang-Hee;Park Hae-Sun;Hwang Eun-Ju;Mun Mi-Young
    • Child Health Nursing Research
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    • v.9 no.2
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    • pp.206-220
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    • 2003
  • Purpose: this study was intended to search the relationship between perception of the infant temperament in mother of infant at the age of 1~12 months and maternal confidence and satisfaction in performing maternal role, and to submit a basic data to establish a nursing intervention program which is helpful for determination of infant development and performing maternal role promotion by identify variables associated with infant temperament. Method: The subjects of this study were 300 mothers of infant at the age of 1~12 months who visited well baby clinic in 4 hospitals in Busan city and Kyoung-Nam province. Final analysis was performed in 293 cases. Seven cases was excluded in this study because of its inappropriate data collection. The data was collected from 1st July to 15th August 2002. The questionaries which were fill-up by mother were collected. Infant temperament was measured by using the tool of 'what my baby is like'(WBL) which was developed by Priham et. al.(1994) and translated by Bang(1999). The scale of postpartum self evaluation which was developed by Lederman et al(1981) and translated by Lee(1992) was used for the confidence and satisfaction of maternal role. All statistical analyses were performed using SPSS-PC for window, version 10.0: frequency, percentage, minimum, maximum, mean, SD, t-test, ANOVA, Post-hoc test(Scheffe's test), Pearson Correlation Coefficients. Result: The mean score of maternal perception of the infant temperament was 6.17±1.04, and mother recognized her infant as positive. The mean score of confidence of maternal role was 2.89± .41 and this revealed in an average level. The mean score of satisfaction of maternal role was 3.29± .51 and this revealed in a higher level. There was a weak significant positive correlation between the score of maternal perception of infant temperament and confidence of maternal role(r=0.176, P= .003), but there was no significant correlation between satisfaction of maternal role(P> .05). It revealed the more maternal perception of the infant temperament as positive, the higher confidence of maternal role. There was a moderate significant positive correlation between confidence of maternal role and satisfaction of maternal role(r=0.410, P= .000). It revealed the more confidence of maternal role, the higher satisfaction of maternal role. The variables related with the score of maternal perception of infant temperament were the type of delivery (t=-2.600, P= .010), experience of learning baby care(t=2.382, P= .018), maternal perception on baby's health status(F=3.467, P= .033), maternal perception on her health status(F=3.467, P= .027), baby's age(F=3.080, P= .028). Conclusion: Our result showed the confidence of maternal role was increased as the maternal perception of infant temperament was positive, and conformed that the confidence of maternal role was also related with satisfaction of maternal role. Prenatal education, type of delivery, baby's age were also related with the maternal perception of infant temperament. So, nursing intervention program of developmental stage maybe necessary in order to help maternal perception of infant temperament as positive, and it will be increased the confidence of maternal role and satisfaction of performing maternal role which was considered as real indicate of achievement of maternal role.

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