한미염산펙소페나딘정 120 mg의 생물학적 동등성

고인자,이엔티엔하이,지상철 한국임상약학회 2006 한국임상약학회지 Vol.16 No.1

Fexofenadine, one of selective histamine receptor antagonists, has been used for the treatment of seasonal allergic rhinitis and chronic idiopathic urticaria. The bioequivalence of two fexofenadine hydrochloride preparations, containing 120 mg fexofenadine hydrochloride, was evaluated according to the guidelines of Korea Food & Drug Administration(KFDA). The test product was Hanmi Fexofenadine Hydrochloride Tablet made by Hanmi Pharm. Co. and the reference product was Allegra Tablet made by Handok Parmaceuticals Co.. Twenty healthy male subjects were randomly divided into two groups and a cross-over study was employed. After one tablet was orally administered, blood was taken at predetermined time intervals and the concentration of fexofenadine in plasma was determined using a validated HPLC method with fluorescence detector. Two pharmacokinetic parameters, , were calculated and analyzed statistically for the evaluation of bioequivalence of the two products. Analysis of variance was carried out using logarithmically transformed parameter values. The 90% confidence intervals of were log 1.149 and log 1.109, respectively. These values were within the acceptable bioequivalence intervals of log 0.8 to log 1.25. Thus, the criteria of the KFDA guidelines for the bioequivalence was satisfied, indicating that Hanmi Fexofenadine Hydrochloride Tablet 120 mg is bioequivalent to Allegra Tablet 120 mg.

알레그라정(염산펙소페나딘 180mg)에 대한 한미염산펙소페나딘정의 생물학적 동등성

고인자 韓國藥劑學會 2006 Journal of Pharmaceutical Investigation Vol.36 No.1

모노콜정에 대한 콩커정의 생물학적 동등성 평가

고인자,지상철 한국임상약학회 2004 한국임상약학회지 Vol.14 No.2

Bisoprolol, one of the antagonist, has been used for the treatment of mild to moderate essential hypertension anti stable angina pectoris. The oral bloavailability of bisoprolo1 is high and the drug has a long elimination half-life, , which allows once-daily administration. The bioequivalence of two bisoprolol preparations was evaluated according to the guidelines of Korea Food & Drug Administration (KFDA). The test product was Concor made by Newgenpharm and the reference product was Monocor made by Wyeth Korea. Twenty healthy male subjects, 23.8 (21-30) years old and 03.8(52-92) kg, were randomly divided into two groups and a randomized cross-over study was employed. After two tablets containing 10 mg bisoprolol hemifumarate were orally administered, blood was taken at predetermined time intervals and the concentration of bisoprolol in plasma was determined using an HPLC method with fluorescence detector. Two pharmacokinetic parameters, were calculated and analyzed statistical]y for the evaluation of bioequivalence of the two products. Analysis of variance was carried out using logarithmically transformed parameter values. The confidence intervals of were log These values were within the acceptable bioequivalence intervals of log . Thus, the criteria of the KFDA guidelines for the bioequivalence was satisfied, indicating that Concor tablet is bioequivalent to Monocor tablet.

洞長의 리더십 유형과 성별이 직무만족과 조직몰입에 미치는 영향 연구: 제주특별자치도 洞 주민센터 직원의 인식을 중심으로

고인자,양덕순 한국지방행정학회 2013 한국지방행정학보 (KLAR) Vol.10 No.2

In this study, by analyzing empirically the impact of Dong office head's gender and attitude toward the type of his or her leadership on job satisfaction and organizational commitment, the author looks into leadership factors that can create organizational members' achievement and build citizen credibility on the front-line agency that performs administrative tasks. Another objective of this research is to utilize the results as a basis for exerting a desirable administrative leadership, and help to establish and improve the human resource management system in the public sector. In the pursuit of this purpose of this study, literature review and empirical studies by survey method were used. In the literature review, domestic and international leadership theory, relative academic articles and books were comprehensively analyzed and used for setting the research model and research hypotheses. In the parameter settings for an empirical study, the type of leadership as independent variables is divided into two types such as transformational leadership and transactional leadership. The gender of the dong(village) office head was set dummy variable of the independent variables. Empirical research methods using a questionnaire organized with these key parameters were conducted toward workers from Jeju-31 Dong Community Center (Jeju-19 dongs, Seogwipo-12 dongs). The main results of this study are summarized as follows. Firstly, the transformational leadership and transactional leadership of head person at dong office had a significant effect on job satisfaction of organizational members' and their commitment, and the transactional leadership turned out to have more significant effect on job satisfaction and organizational commitment. Secondly, the leadership impact on job satisfaction and organizational commitment was greater when the workers serve as woman head persons rather than man head persons.

닛셀정에 대한 헤파필연질캡슐의 생물학적 동등성 평가

고인자,지상철,Ko, In-Ja,Chi, Sang-Cheol 대한약학회 2004 약학회지 Vol.48 No.6

Biphenyl dimethyl dicarboxylate (DDB) has been used for the treatment of chronic viral hepatitis B and drug-induced hepatitis through the inhibition of lipid peroxidation and c ovalent binding of drug metabolites to lipids of microsomes. The bioequivalence of two DDB products was evaluated according to the guidelines of KFDA. The test product was Hepaphil soft capsule(R) made by KMS Pharm. Co. Containing 3 mg DDB and the reference product was Nissel tablet(R) made by Taerim Pharm. Co. Containing 25 mg DDB. Twenty healthy male subjects, 25.4(22~30) years old and 66.7(54~77)kg, were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After two tablets or two capsules were orally administered, blood was taken at predetermined time intervals and the concentration of DDB in plasma was determined using a validated HPLC method with UV detector. Two pharmacokinetic parameters, $AUC_t$ and $C_{max}$, were calculated and analyzed statistically for the evaluation of bioequivalence of the two products. Analysis of variance was carried out using logarithmically transformed parameter values. The 90% confidence intervals of $AUC_t$ and $C_{max}$ were log 0.91~log1.00 and log 1.05~log 1.15, respectively. These values were within the acceptable bioequivalence intervals of log 0.8 to log 1.25. Thus, the criteria of the KFDA guidelines for the bioequivalence was satisfied, indicating that Hepaphil soft capsule is bioequivalent to Nissel tablet.

아달라트오로스정에 대한 한미니페디핀서방정의 생물학적 동등성 평가

고인자,지상철 한국임상약학회 2004 한국임상약학회지 Vol.14 No.2

Nifedipine, one of calcium channel antagonists, has been used for the treatment of mild to moderate hypertention, angina pectoris, Raynaud's phenomenon and various other cardiovascular diseases. Because of its short biological half-life, several sustained-release (SR) formulations of nifedipine have been developed. and used clinically. The bioequivalence of the two nifedipine SR preparations was evaluated according to the guidelines of KFDA. The test product was Hanmi Nifedipine SR made by Hanmi Pharm. Co. and the reference was Adalat Oros made by Bayer Korea. Thirty healthy male subjects were divided into two groups and a randomized cross-over study was employed. After one SR tablet containing 33 mg of nifedipine was orally administered, blood sample was taken at predetermined time intervals and the concentrations of nifedipine in plasma were determined using a validated HPLC method with UV detector. Two pharmacokinetic parameters, , were calculated and analyzed statistically for the evaluation of bioequivalence of the two products. Analysis of variance was carried out using logarithmically transformed parameter values. The confidence intewals of the These values were within the acceptable bioequivalence intervals from log 0.8 to log 1.25 in KFDA guidelines. Thus, the criteria of the KFDA guidelines for the bioequivalence was satisfied, indicating that Hanmi Nifedipine SR tablet is bioequivalent to Adalat Oros tablet.

세로자트정(파록세틴 20㎎)에 대한 삼천리파록세틴정의 생물학적동등성

고인자,지상철 한국약제학회 2004 Journal of Pharmaceutical Investigation Vol.34 No.6

Paroxetine. a potent and selective serotonine reuptake inhibitor. has been used for the treatment of depression, obsessive-compulsive disorder, panic disorder and social phobia. The bioequivalence of two paroxetine preparations was evaluated according to the guidelines of Korea Food & Drug Administration (KFDA). The test product was Samchullv Paroxetine tablet`' made by Samchullv Pharm. Co. and the reference product was Seroxat tablet made by GlaxoSmithKline. Twenty healthy male subjects. 22.4±2.6 years old and 63.8±4.2 kg. were divided into two groups and a randomized 2x2 cross-over study was employed. After one tablet containing 20 mg paroletine was orally administered. blood was taken at predetermined time intervals and the concentration of paroletine in plasma was determined using a validated HPLC method with fluorescence detector. Two pharmacokinetic parameters. AUCr and Cma.. were calculated and analyzed statistically for the evaluation of bioequivalence of two products. Analysis of variance was carried out using logarithmically transformed parameter values. The 90° 0 confidence intervals of AUCr and Cmax were log 0.84-log 1.16 and log 0.85-log 1.14. respectively. These values were within the acceptable bioequivalence intervals of log 0.8 to log 1.25. Thus. the criteria of the KFDA guidelines for the bioequivalence was satisfied. indicating that Samchullv Paroxetine tablet is bioequivalent to Seroxat tablet.

한국산 하고초류의 약물학적 연구(Ⅰ) : 소염작용에 대하여

고인자(In Ja Ko),유승조(Seung Jo Yoo),이은방(Eun Bang Lee) 한국생약학회 1986 생약학회지 Vol.17 No.3

The whole plants of Prunella vulgaris (Labiatae) and Thesium chinense (Santalaceae) are used as Hakocho(夏枯草) in the market in Korea. In oriental medicine, these herb drugs are prescribed as a diuretic or antiinflammatory drugs. In order to investigate the efficacy of the plants, the extracts were bioassayed for antiinflammatory action. The water extracts of Prunella Herba and Thesii Herba showed remarkable anticarrageenin effect and significant inhibition of the swellings in adjuvant arthritis in rats. However, the extracts did not show any inhibition of leucocyte emigration in CMC pouch in rats.

한국산 하고초류의 약물학적 연구(Ⅱ) : 중추신경 및 이뇨작용에 대하여

고인자(In Ja Ko),유승조(Seung Jo Yoo),이은방(Eun Bang Lee) 한국생약학회 1986 생약학회지 Vol.17 No.3

This study is an attempt to investigate the effects of the water extracts of the whole plants of Prunella vulgaris (Labiatae) and Thesii chinense (Santalaceae) on the acute toxicity, the activities on central nervous system and the diuretic action. The acute toxicities shown by LD_(50) were estimated to be more than 3000 ㎎/㎏ p.o. and 1,000 ㎎/㎏ s.c. in the extracts of Prunellae Herba and Thesii Herba, respectively, in mice. The extracts at a dose of 2,000 ㎎/㎏ p.o. did not show any activities on central nervous system, i.e, sedative, analgesic, hypothermic and anticonvulsant actions. The urination in rats was increased by 45.5% and 57.6% when 100㎎/㎏ of each of the extracts were given orally. The results obtained revealed that the water extracts possessed weak diuretic actions without any of central nervous system activities. Furthermore, it is considered that the potassium in the extract may play a role in the diuretic action.

한국산 하고초류의 약물학적 연구 (Ⅱ) : 중추신경 및 이뇨작용에 대하여

고인자(In Ja Ko),유승조(Seung Jo Yoo),이은방(Eun Bang Lee) 한국생약학회 1985 생약학회지 Vol.16 No.1

This study is an attempt to investigate the effects of the water extracts of the whole plants of Prunella vulgaris (Labiatae) and Thesium chinense (Santalaceae) on acute toxicity, activities oncentral nervous system and the diuretic action. The acute toxicities of the extracts shown by LD_(50) were estimated to be more than 3,000㎎/㎏ p.o. and 1,000㎎/㎏ i.p. in mice. The extracts of the herb drugs at doses of 1, 000 and 2, 000㎎/㎏ p.o. did not show any activities on central nervous system, i. e. sedative, analgesic, hypothermic and anticonvulsant action. In diuretic action, the urination in rats was increased by 45.5% and 57. 6% when 1, 000㎎/㎏ of each of the extract of Prunellae Herba and Thesii Herba were given orally. The potassium contents in 1,000㎎ of the water extracts of Prunellae Herba and Thesii Herba were 96㎎ and 118㎎, respectively. From these results, it was revealed that the water extracts of the herb drugs possessed weak diuretic actions with least acute toxicities and without any of central nervous activities. Furthermore, it is considered that the potassium in the extract might play a role in diuretic action.