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고인철,주문솔,조지혜 한국폐기물자원순환학회 2023 한국폐기물자원순환학회지 Vol.40 No.3
The transition to a circular economy is essential for the sustainability of our society and carbon neutrality. Many countries have established goals and strategies for switching to the circular economy, and are diagnosing how various elements of the circular economy are developing over time. In South Korea, the First Basic Plan on Resource Circulation has set four key indicators to check the progress of implementation, but all of them are limited to waste management. Therefore, this study aims to develop indicators to monitor resource efficiency and circularity by expanding the scope to the entire life cycle of products. It is expected to evaluate the status of the transition to the circular economy in Korea and establish a statistical base for achieving mid- and long-term goals.
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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.
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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.
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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.
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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.
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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.
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