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메바코® 정(로바스타틴 20㎎)에 대한 바이로틴® 정의 생물학적 동등성 시험
조요나,서성훈,류재환,김남재,이경태 한국병원약사회 1999 병원약사회지 Vol.16 No.3
Bioequivalence of two lovastatin tables, Mevacor (Choongwae Pharma Corporation) and Bairotin (Samsung Pharm. IND. Co.), was evaluated according to the guideline of KFDA. Sixteen healthy male volunteers (21-26 years old) were divided into two groups and a randomized 2×2 cross-over study was employed. After 80㎎ of lovastatin was orally administrated, blood was taken at 1, 2, 2.5, 3, 3.5, 4, 6, 8, 10 and 12 hours after administration and just before administration. Lovastatin is rapidly metabolized to β-hydroxy acid form that is pharmacologically active. So the concentrations of its β-hydroxy acid form were determined by HPLC method with UV detection. The pharmacokinetic parameters(AUCt, Cmax and Tmax,) were calculated and ANOVA test was used for the statistical analysis of parameters. Differences in ACUt, Cmax and Tmax between two tables were 0.47, 3.13 and 5.75% respectively. All powers(1-β) for AUCt, Cmax and Tmax were more than 0.9. Detectable differences(Δ) and confidence interval were all less than ±20%. All the parameters above met the criteria of KFDA for bioequivalence and indicated that Bairotin® tables are bioequivalent to Mevacor® tablets.
조프란® 정(온단세트론 8mg)에 대한 자프론® 정의 생물학적 동등성 시험
조요나,오한석,류재환,김남재,서성훈,이경태 한국병원약사회 2000 病院藥師會誌 Vol.17 No.1
Bioequivalence of two ondansetron, Zofran® (Korea Graxowellcom Ltd.) and Gafron® (Asia Pharm. Ind. Co.), was evaluated according to the guideline of KFDA. Sixteen healthy male volunteers (21-26 years old) were divided into two groups and a randomized 2×2 cross-over study was employed. After 8㎎ of ondansetron was orally administered, blood was taken at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8 and 12 hours and just before administration. Plasma was analyzed for ondansetron and internal standard (loxapine) by a sensitive and validated HPLC assay. The pharmacokinetic parameters (AUCt, C_(max) and T_(max)) were calculated and ANOVA test was used for the statistical analysis of parameters. Differences in AUCt, C_(max) and T_(max) between two tablets were 2.87-3.17 and 0.00% respectively. All powers (1-β) for AUCt, C_(max) and T_(max) were more than 0.9. Detectable differences (Δ) and confidence interval were all less than ± 20%. All the parameters above met the criteria of KFDA for bioequivalence and indicated that Gafron® Tablets are bioequivalent to Zofran® Tablets.
새로운 백금 착체(II) 화합물의 흰쥐 혈장에서 대사체 확인
김종환,조요나,노영수,서성훈,정지창,장성구,이규홍,이주한,이경태,Kim, Jong-Whan,Jo, Yo-Na,Rho, Young-Soo,Seo, Seong-Hoon,Jung, Jee-Chang,Chang, Sung-Goo,Lee, Kyoe-Heung,Lee, Joo-Han,Lee, Kyung-Tae 한국약제학회 1998 Journal of Pharmaceutical Investigation Vol.28 No.3
KHPC-002 $[(trans-l-diaminocyclohexane-bis-l,2(diphenylphosphinoethane)platinum)\;{\cdot}2NO_3]$ and $KHPC-006[(cis-diaminocyclohexane-bis-1,2(diphenylphosphinoethane)platinum)\;{\cdot}2NO_3]$ were synthesized as candidates for third platinum antitumor agent. Before their pharmacokinetic study, we optimized the analytical condition with HPLC and identified the major metabolites in the rat plasma. HPLC analysis by $C_{18}$ reverse-phase column showed that standard peak of both compounds appeared rapidly at around 1 minutes, whereas metabolites of KHPC-002 and KHPC-006 which were extracted from plasma after single I.V. administration in rats or incubation for 24 hr at $37^{\circ}C$ showed retention time of $10{\sim}11$ minutes. These metabolites were identified as the major compound by Matrix Associated Laser Deposition/Ionization (MALDI), which only lose the 2 molecules of $NO_3$. Based on these results, we suggest that the major metabolites of KHPC-002 and KHPC-006 were [trans-l-diamino-cyclohexane-bis-l,2(diphenylphosphinoethane)platinum] and [cis-diaminocyclohexane-bis-l.2(diphenylphosphinoethane)platinum], respectively.
란크릭 캅셀(플루옥세틴 20mg)에 대한 프로작 캅셀의 생물학적 동등성 시험
심상범,조요나,오한석,류재환,이경태,김남재,서성훈 경희대학교 동서의학연구소 2001 東西醫學硏究所 論文集 Vol.2000 No.-
Bioequivalence of two flouxetine capsule, ProzacR (Lilly kora Ltd.) and LanclicR (Samsung Pharm. IND. Co.), was evalated according to the guideline of KFDA. Twenty four healthy male volunteers (21-26 years old) were divided into two groups and a randomized 2×2 cross-over study was employed. After 60mg of fluoxetine was orally administered, blood was taken at 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 32, 48 and 72 hours after administration and just before administration. Plasma was analyzed for fluoxetine and internal standard (clomipramine) by a sensitive and validated HPLC assay. The pharmaco kinetic parameters (AUCt, Cmax and Tmax) wre calculated and ANOVA test was used for the statistical analysis of parameters. Differences in (AUCt, Cmax and Tmax between two capsules were -0.90, 3.46 and -14.08% respectively. All powers (1-β) for AUGt, Cmax and Tmax were more than 0.9. Detectable differences (Δ) and confidence interval were all less than ±20%. All the parameters above met the criteria of KFDA for bioequivalence and indicated that LanclicR capsules are bioequivalent to ProzacR capsules.
란크릭® 캅셀(플루옥세틴 20mg)에 대한 프로작® 캅셀의 생물학적 동등성 시험
심상범,조요나,오한석,류재환,이경태,김남재,서성훈 한국병원약사회 2000 병원약사회지 Vol.17 No.1
Bioequivalence of two flouxetine capsule, Prozac® (Lilly korea Ltd.) and Lanclic® (Samsung Pharm. IND. Co.), was evaluated according to the guideline of KFDA. Twenty four healthy male volunteers (21-26 years old) were divided into two groups and a randomized 2×2 cross-over study was employed. After 60㎎ of fluoxetine was orally administered, blood was taken at 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 32, 48 and 72 hours after administration and just before administration. Plasma was analyzed for fluoxetine and internal standard (clomipramine) by a sensitive and validated HPLC assay. The pharmacokinetic parameters (AUC_(t), C_(max) and T_(max)) were calculated and ANOVA test was used for the statistical analysis of parameters. Differences in AUC_(t), C_(max) and T_(max) between two capsules were -0.90, 3.46 and -14.08% respectively. All powers (1-β) for AUC_(t), C_(max) and T_(max) were more than 0.9. Detectable differences (Δ) and confidence interval were all less than ±20%. All the parameters above met the criteria of KFDA for bioequivalence and indicated that Lanclic® capsules are bioequivalent to Prozac® capsules.
프로작® 캅셀(플루옥세틴 60㎎)에 대한 플루틴® 캅셀의 생물학적 동등성 시험
남기원,천성국,오한석,조요나,류재환,김남재,서성훈,이경태 한국병원약사회 2001 병원약사회지 Vol.18 No.4
Bioequivalence of two fluoxetine, Prozac®(Lilly Korea Ltd.) and Flutin®(Daewon Pharm. Co. LTD.), was evaluated according to the guideline of KFDA. Twenty four healthy male volunteers(21-26 years old) were divided into two groups and a randomized 2×2 cross-over study was employed. After 60 ㎎ of fluoxetine was orally administered, blood was taken at 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 32, 48 and 72 hours after administration and just before administration. Plasma was analyzed for fluoxetine and internal standard(clomipramine) by a sensitive and validated HPLC assay. The pharmacokinetic parameters (AUC_(t), C_(max) and T_(max,) were calculated and ANOVA test was used for the statistical analysis of parameters. Differences in AUC_(t), C_(max) and T_(max) between two capsules were 3.24, 0.86 and -3.86 % respectively. All powers(1-β) for AUC_(t), C_(max) and T_(max) were more than 0.9. Detectable differences(Δ) and confidence interval were all less than ±20 %. All the parameters above met the criteria of KFDA for bioequivalence and indicated that Flutin® capsules are bioequivalent to Prozac® capsules.
새로운 백금 착체(2) 화합물의 흰쥐 혈장에서 대사체 확인
김종환(Jong Whan Kim),조요나(Yo Na Jo),노영수(Young Soo Rho),서성훈(Seong Hoon Seo),정지창(Jee Chang Jung),장성구(Sung Goo Chang),이규홍(Kyoe Heung Lee),이주한(Joo Han Lee),이경태(Kyung Tae Lee) 한국약제학회 1998 Journal of Pharmaceutical Investigation Vol.28 No.3
N/A KHPC-002[(trans-l-diaminocyclohexane-bis-1,2(diphenylphosphinoethane)platinum)·2NO₃] and KHPC-006[(cis-diaminocyclohexane-bis-1,2(diphenylphosphinoethane)platinum)·2NO₃] were synthesized as candidates for third platinum antitumor agent. Before their pharmacokinetic study, we optimized the analytical condition with HPLC and identified the major metabolites in the rat plasma. HPLC analysis by C_(18) reverse-phase column showed that standard peak of both compounds appeared rapidly at around 1 minutes, whereas metabolites of KHPC-002 and KHPC-006 which were extracted from plasma after single I.V. administration in rats or incubation for 24 hr at 37℃ showed retention time of 10∼11 minutes. These metabolites were identified as the major compound by Matrix Associated Laser Deposition/Ionization (MALDI), which only lose the 2 molecules of NO₃. Based on these results, we suggest that the major metabolites of KHPC-002 and KHPC-006 were [trans-l-diamino-cyclohexane-bis-1, 2(diphenylphosphinoethane)platinum] and [cis-diaminocyclohexane-bis-1,2(diphenylphosphinoethane)platinum], respectively.