• Title/Summary/Keyword: $T_{max}$

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Bioequivalence of Shinil Cefadroxil Capsule to Duricef Capsule (cefadroxil 500 mg) (듀리세프 캅셀(세파드록실 500 mg)에 대한 신일 세파드록실 캅셀의 생물학적 동등성)

  • 유호정;최민구;김경식;정석재;심창구
    • Biomolecules & Therapeutics
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    • v.10 no.4
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    • pp.303-308
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    • 2002
  • A bioequivalence study of Shin II Cefadroxil capsule (Shin II Pharm. Co. Ltd.) to Duricef capsule(Bo Ryung Pharm. Co. Ltd.), each containing 500 mg of cefadroxil, was conducted. Twenty three healthy Korean male subjects administered each formulation at the dose of 1 capsule (500 mg as cefadroxil) in 2 $\times$ 2 cross-over study. There was a I-week washout period between the doses. Plasma concentrations of cefadroxil were monitored for a period of 8 hr after each administration by an LC/UV method. Area under the plasma concentration-time curve up to 8 hr ($AUC_t$) was calculated by a linear trapezoidal method. $C_{max}$ was compiled from the plasma drug concentration-time data. ANOVA test was conducted for logarithmically transformed $AUC_t$ and $C_{max}$ The results showed that there are no significant differences in $AUC_t$ and $C_{max}$ between the two formulations: The differences between d1e formulations in these log transformed parameters were all for less than 20% (i.e., -0.57%, 3.84% for $AUC_t$ and $C_{max}$, respectively). The 90% confidence intervals for the log transformed data were within the acceptance range of log 0.8 to log 1.25 (i.e., log 0.94~log 1.04 and log 0.95~log 1.10 for $AUC_t$ and $C_{max}$, respectively). Based on d1e bioequivalence criteria of KFDA guidelines, the two formulations of cefadroxil were concluded to be bioequivalent.

Bioequivalence of Lovaload Tablet to Mevacor Tablet (Lovastatin 20 mg) (메바코 정 (로바스타틴 20 mg)에 대한 로바로드 정의 생물학적 동등성)

  • Song, Woo-Heon;Kim, Jung-Min;Cho, Seong-Wan;Kim, Jae-Hyun;Lim, Jong-Lae;Shin, Hee-Jong;Choi, Young-Wook
    • Journal of Pharmaceutical Investigation
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    • v.28 no.4
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    • pp.283-288
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    • 1998
  • Lovastatin, one of the potent cholesterol-lowering agents, is an inactive lactone prodrug which is metabolized to its active open acid, lovastatin acid (LVA). Bioequivalence study of two lovastatin preparations, the test drug ($Mevacor^{\circledR}$: Chungwae Pharmaceutical Co., Ltd.) and the reference drug ($Lovaload^{\circledR}$: Chong Kun Dang Pharmaceutical Co., Ltd.), was conducted according to the guidelines of Korea Food and Drug Administration (KFDA). Fourteen healthy male volunteers, $23.9{\pm}3.9$ years old and $67.6{\pm}8.0$ kg of body weight in average, were divided randomly into two groups and administered the drug orally at the dose of 160 mg as lovastatin in a $2{\times}2$ crossover study. Plasma concentrations of lovastatin acid were analysed by HPLC method for 12 hr after administration. The extent of bioavailability was obtained from the plasma concentration-time profiles of total lovastatin acid after alkaline hydrolysis of the plasma samples. By alkaline hydrolysis, trace amounts of unmetabolized lovastatin were converted to lovastatin acid. The $AUC_{0-12hr}$ was calculated by the linear trapezoidal rule method. The $C_{max}$ and $T_{max}$ were compiled directly from the plasma drug concentration-time data. Student's t-test indicated no significant differences between the formulations in these parameters. Analysis of variance (ANOVA) revealed that there were no differences in AUC, $C_{max}$, and $T_{max}$ between the formulations. The apparent differences between the formulations were far less than 20% (e.g., 7.07, 5.77 and 1.18% for AUC, $C_{max}$, and $T_{max}$, respectively). Minimum detectable differences(%) between the formulations at ${\alpha}=0.05$ and $1-{\beta}=0.8$ were less than 20% (e.g., 17.2, 15.1, and 15.9% for AUC, Cmax, and Tmax, respectively). The 90% confidence intervals for these parameters were also within ${\pm}20%$ (e.g.. $-5.20{\sim}19.3$, $-5.00{\sim}16.5$, and $-10.2{\sim}12.5%$ for AUC, $C_{max}$, and $T_{max}$, respectively). These results satisfied the bioequivalence criteria of KFDA guidelines, indicating that the two formulations of lovastatin were bioequivalent.

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Bioequivalence of Carvelol Tablet to Dilatrend Tablet (Carvedilol 25 mg) (딜라트렌 정(카르베딜롤 25 mg)에 대한 카베롤 정의 생물학적 동등성)

  • Cho, Hea-Young;Lee, Moon-Seok;Park, Soon-Cheol;Lim, Dong-Koo;Moon, Jai-Dong;Lee, Yong-Bok
    • Journal of Pharmaceutical Investigation
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    • v.31 no.4
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    • pp.289-295
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    • 2001
  • Carvedilol is an antihypertensive and antianginal compound that combines nonselective beta-adrenoceptor blocking and vasodilation properties and is devoid of intrinsic sympathomimetic activity. The purpose of the present study was to evaluate the bioequivalence of two carvedilol tablets, $Dilatrend^{TM}$ (Chong Kun Dang Pharmaceutical Co., Ltd.) and $Carvelol^{TM}$ (Dae Won Pharmaceutical Co., Ltd.), according to the prior and revised guidelines of Korea Food and Drug Administration (KFDA). The carvedilol release from the two carvedilol tablets in vitro was tested using KP VII Apparatus II method with various different kinds of dissolution media (pH 1.2, 4.0, 6.8 buffer solution, water and blend of PSB80 into water). Eighteen normal male volunteers, $24.22{\pm}1.86$ years in age and $64.81{\pm}4.56\;kg$ in body weight, were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After one tablet containing 25 mg of carvedilol was orally administered, blood was taken at predetermined time intervals and the concentrations of carvedilol in serum were determined using HPLC method with fluorescence detector. The dissolution profiles of two carvedilol tablets were very similar at all dissolution media. Besides, 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 non-transformed and logarithmically transformed $AUC_t$ and $C_{max}$. The results showed that the differences in $AUC_t$, $C_{max}$ and $T_{max}$ between two tablets based on the $Dilatrend^{TM}$ were 2.23%, -2.00% and 0.00%, respectively. Minimum detectable differences $({\Delta})$ at ${\alpha}=0.05$ and $1-{\beta}=0.8$ were less than 20% (e.g., 13.55% and 17.61% for $AUC_t$ and $C_{max}$, respectively). The powers $(l-{\beta})$ at ${\alpha}=0.05$, ${\Delta}=0.2$ for $AUC_t$ and $C_{max}$ were 98.08% and 88.81%, respectively. The 90% confidence intervals were within ${\pm}20%$ (e.g., $-5.69{\sim}10.16$ and $-12.30{\sim}8.30$ for $AUC_t$ and $C_{max}$, respectively). There were no sequence effect between two tablets in logarithmically transformed $AUC_t$ and $C_{max}$. The 90% confidence intervals using logarithmically transformed were within the acceptance range of log(0.8) to log(1.25) (e.g., $0.95{\sim}1.11$ and $0.89{\sim}1.09$ for $AUC_t$ and $C_{max}$, respectively). Two parameters met the criteria of prior and revised KFDA guideline for bioequivalence, indicating that $Carvelol^{TM}$ tablet is bioequivalent to $Dilatrend^{TM}$ tablet.

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Investigation for Shoulder Kinematics Using Depth Sensor-Based Motion Analysis System (깊이 센서 기반 모션 분석 시스템을 사용한 어깨 운동학 조사)

  • Lee, Ingyu;Park, Jai Hyung;Son, Dong-Wook;Cho, Yongun;Ha, Sang Hoon;Kim, Eugene
    • Journal of the Korean Orthopaedic Association
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    • v.56 no.1
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    • pp.68-75
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    • 2021
  • Purpose: The purpose of this study was to analyze the motion of the shoulder joint dynamically through a depth sensor-based motion analysis system for the normal group and patients group with shoulder disease and to report the results along with a review of the relevant literature. Materials and Methods: Seventy subjects participated in the study and were categorized as follows: 30 subjects in the normal group and 40 subjects in the group of patients with shoulder disease. The patients with shoulder disease were subdivided into the following four disease groups: adhesive capsulitis, impingement syndrome, rotator cuff tear, and cuff tear arthropathy. Repeating abduction and adduction three times, the angle over time was measured using a depth sensor-based motion analysis system. The maximum abduction angle (θmax), the maximum abduction angular velocity (ωmax), the maximum adduction angular velocity (ωmin), and the abduction/adduction time ratio (tabd/tadd) were calculated. The above parameters in the 30 subjects in the normal group and 40 subjects in the patients group were compared. In addition, the 30 subjects in the normal group and each subgroup (10 patients each) according to the four disease groups, giving a total of five groups, were compared. Results: Compared to the normal group, the maximum abduction angle (θmax), the maximum abduction angular velocity (ωmax), and the maximum adduction angular velocity (ωmin) were lower, and abduction/adduction time ratio (tabd/tadd) was higher in the patients with shoulder disease. A comparison of the subdivided disease groups revealed a lower maximum abduction angle (θmax) and the maximum abduction angular velocity (ωmax) in the adhesive capsulitis and cuff tear arthropathy groups than the normal group. In addition, the abduction/adduction time ratio (tabd/tadd) was higher in the adhesive capsulitis group, rotator cuff tear group, and cuff tear arthropathy group than in the normal group. Conclusion: Through an evaluation of the shoulder joint using the depth sensor-based motion analysis system, it was possible to measure the range of motion, and the dynamic motion parameter, such as angular velocity. These results show that accurate evaluations of the function of the shoulder joint and an in-depth understanding of shoulder diseases are possible.

THE DIMENSION OF THE CONVOLUTION OF BIPARTITE ORDERED SETS

  • Bae, Deok-Rak
    • Journal of the Korean Mathematical Society
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    • v.36 no.3
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    • pp.633-648
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    • 1999
  • In this paper, for any two bipartite ordered sets P and Q, we define the convolution P * Q of P and Q. For dim(P)=s and dim(Q)=t, we prove that s+t-(U+V)-2 dim(P*Q) s+t-(U+V)+2, where U+V is the max-mn integer of the certain realizers. In particular, we also prove that dim(P)=n+k- {{{{ { n+k} over {3 } }}}} for 2 k n<2k and dim(Pn ,k)=n for n 2k, where Pn,k=Sn*Sk is the convolution of two standard ordered sets Sn and Sk.

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Analysis of the Vibration Characteristic for the Mine Detectable Test Platform (지뢰탐지 실험플랫폼의 진동 특성 분석)

  • Chang, YuShin;Kwak, NoJin;Han, SeungHoon;Ji, UnHo;Ji, ChangJin
    • Proceedings of the Korean Society for Noise and Vibration Engineering Conference
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    • 2014.04a
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    • pp.588-595
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    • 2014
  • In this paper, analysis of the vibration Characteristic for the Mine Detectable Test Platform is described. The test platform system is the multi-sensor mine detectable vehicle. This multi-sensor mine detectable unit is more efficient detection performance than other conventional methods. The test platform system has five subsystems, the UWB(Ultra Wide Band) sensor scanner, the MD(Metal Detector) sensor scanner, the neutron sensor scanner, and the detectable vehicle. We perform the vibration tests for the test platform and analyze the vibration characteristic, such as the max displacement, the max deformation and the max Von-Misses Stress.

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COMPACTNESS OF A SUBSPACE OF THE ZARISKI TOPOLOGY ON SPEC(D)

  • Chang, Gyu-Whan
    • Honam Mathematical Journal
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    • v.33 no.3
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    • pp.419-424
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    • 2011
  • Let D be an integral domain, Spec(D) the set of prime ideals of D, and X a subspace of the Zariski topology on Spec(D). We show that X is compact if and only if given any ideal I of D with $I{\nsubseteq}P$ for all $P{\in}X$, there exists a finitely generated idea $J{\subseteq}I$ such that $J{\nsubseteq}P$ for all $P{\in}X$. We also prove that if D = ${\cap}_{P{\in}X}D_P$ and if * is the star-operation on D induced by X, then X is compact if and only if * $_f$-Max(D) ${\subseteq}$X. As a corollary, we have that t-Max(D) is compact and that ${\mathcal{P}}$(D) = {P${\in}$ Spec(D)$|$P is minimal over (a : b) for some a, b${\in}$D} is compact if and only if t-Max(D) ${\subseteq}\;{\mathcal{P}}$(D).

Physiologically-based pharmacokinetic predictions of intestinal BCRP-mediated drug interactions of rosuvastatin in Koreans

  • Bae, Soo Hyeon;Park, Wan-Su;Han, Seunghoon;Park, Gab-jin;Lee, Jongtae;Hong, Taegon;Jeon, Sangil;Yim, Dong-Seok
    • The Korean Journal of Physiology and Pharmacology
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    • v.22 no.3
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    • pp.321-329
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    • 2018
  • It was recently reported that the $C_{max}$ and AUC of rosuvastatin increases when it is coadministered with telmisartan and cyclosporine. Rosuvastatin is known to be a substrate of OATP1B1, OATP1B3, NTCP, and BCRP transporters. The aim of this study was to explore the mechanism of the interactions between rosuvastatin and two perpetrators, telmisartan and cyclosporine. Published (cyclosporine) or newly developed (telmisartan) PBPK models were used to this end. The rosuvastatin model in Simcyp (version 15)'s drug library was modified to reflect racial differences in rosuvastatin exposure. In the telmisartan-rosuvastatin case, simulated rosuvastatin $C_{maxI}/C_{max}$ and $AUC_I/AUC$ (with/without telmisartan) ratios were 1.92 and 1.14, respectively, and the $T_{max}$ changed from 3.35 h to 1.40 h with coadministration of telmisartan, which were consistent with the aforementioned report ($C_{maxI}/C_{max}$: 2.01, $AUC_I/AUC$:1.18, $T_{max}:5h{\rightarrow}0.75h$). In the next case of cyclosporine-rosuvastatin, the simulated rosuvastatin $C_{maxI}/C_{max}$ and $AUC_I/AUC$ (with/without cyclosporine) ratios were 3.29 and 1.30, respectively. The decrease in the $CL_{int,BCRP,intestine}$ of rosuvastatin by telmisartan and cyclosporine in the PBPK model was pivotal to reproducing this finding in Simcyp. Our PBPK model demonstrated that the major causes of increase in rosuvastatin exposure are mediated by intestinal BCRP (rosuvastatin-telmisartan interaction) or by both of BCRP and OATP1B1/3 (rosuvastatin-cyclosporine interaction).

The Regulatory Effect of Natural-Derived 6 Compounds Mixture on Adipocytes (천연 유래 6 종 혼합물의 지방세포 조절 효과)

  • Yuna, Kim;Youngsu, Jang;Deokhoon, Park;Eunsun, Jung
    • Journal of the Society of Cosmetic Scientists of Korea
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    • v.48 no.4
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    • pp.331-342
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    • 2022
  • Obesity is one of the metabolic diseases caused by excessive differentiation and accumulation of adipose tissue due to an imbalance between energy intake and consumption. In this study, we investigated the anti-obesity effect of SliMax, a natural-derived 6 compounds mixture, by using 3T3-L1 cells. As a result, SliMax showed the inhibitory effect on adipocyte differentiation through down-regulation of the PPARγ and C/EBPα expression, which are known to regulate the late adipogenesis stage. In the process of lipolysis on differentiated 3T3-L1 cells, SliMax accelerated decomposition of large-sized unilocular lipid droplet into numerous small-sized multilocular lipid droplets through up-regulation of the expression of lipolysis-related proteins ATGL and HSL. Finally, in order to confirm the effect of SliMax on induction of brown adipocyte, the expression of UCP-1 and the amount of mitochondria were confirmed by immunofluorescent staining, and as a result, SliMax increased the expression of UCP-1 and the amount of mitochondria in fat cells. Taken together, those results suggest that SliMax, a naturally-derived mixture, have a potential to be anti-obesity agent through exerting inhibitory effect on the formation of lipid droplet by suppression of adipogenesis and stimulation of lipolysis, and browning effect associated with generation of heat energy and energy consumption.

Studies on the Preparation of $T_3-BSA,\;T_4-BSA$ Conjugates, and Radioimmunoassay Use of the Produced Antisera ($T_3-BSA,\;T_4-BSA$ 접합체 제조 및 생성항체의 방사면역측정적 이용 연구)

  • Awh, Ok-Doo;Kim, Jae-Rok
    • The Korean Journal of Nuclear Medicine
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    • v.14 no.1
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    • pp.45-56
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    • 1980
  • $T_3-BSA\;and\;T_4-BSA$ conjugates were prepared and identified spectrophotometrically. The ${\lambda}max$ of the conjugates was just coincided with that of BSA, but the molar extinction coefficients of the conjugates were generally larger than that of BSA itself. The molar ratios of $T_3:\;BSA\;and\;T_4:\;BSA$ in the prepared conjugates were found to be 9:1 and 5:1, respectively. The titers of the $T_3$ antisera were generally higher (max. $1.5{\times}10^4:1$) than those of $T_3$ (max. $2{\times}10^3:1$), and the average cross reactivity of the $T_3$ antibody with $T_3$ was lower (0.45%) than that of $T_4$ antibody with $T_3(3{\sim}4%)$. The results of the study indicate that the predominant cause of the lower titers and the lower specificity of the $T_4$ antisera comparing with those of $T_3$ is mainly due to the unstability of the $T_4-BSA$ and consequent degradation of the conjugate to $T_3-BSA$ during preparation, purification, and even during immunization. The lower molar ratio of $T_4$ to BSA in the preparation stage is also considered to be a minor factor. By measuring $T_3,\;T_4$ levels in the reference control serum, it has been confirmed that the prepared antisera can sufficiently be utilized, respectively, in the established radioimmunoassay systems.

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