• Journal of Pharmaceutical Investigation
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• v.29 no.4
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• pp.355-360
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• 1999

Triflusal is a new antithrombotic agent which inhibits both platelet cyclooxygenase and c-AMP phosphodiesterase activity. The purpose of the present study was to evaluate the bioequivalence of two triflusal capsules, $Disgren^{TM}$ (Myung-In Pharmaceutical Co., Ltd.) and $Tigriri^{TM}$ (Hana Pharmaceutical Co., Ltd.) according to the guidelines of Korea Food and Drug Administration (KFDA). Eighteen normal male volunteers, $22.94{\pm}1.83$ in age and $63.7l{\pm}10.43$ kg in body weight, were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After one capsule containing 300 mg of triflusal was orally administered, blood was taken at predetermined time intervals and the concentrations of triflusal in serum were determined using HPLC method with UV detector. 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. The results showed that the differences in $AUC_t$ $C_{max}$ and $T_{max}$ between two capsules were -0.30%, 0.81 % and -3.03%, respectively when calculated against the $Disgren_{TM}$ capsule. The powers $(1-{\beta})$ for $AUC_t$ $C_{max}$ and $T_{max}$ were 98.29%,84.73% and 81.02%, respectively. Minimum detectable differences $({\Delta})$ at ${\alpha}=0.1$ and $1-{\beta}=0.8$ were all less than 20% (e.g., 12.91%, 18.46% and 19.65% for $AUC_t$ $C_{max}$ and $T_{max}$ respectively). The 90% confid,ence intervals were all within ${\pm}20%$(e.g., $-8.97{\sim}8.37$, $-11.58{\sim}13.22$ and $-16.23{\sim}10.17$ for $AUC_t$ $C_{max}$ and $T_{max}$, respectively). All of the above parameters ($1-{\beta}, {\Delta}$ and 90% confidence intervals) met the criteria of KFDA for bioequivalence, indicating that $Tigriri^{TM}$ capsule is bioequivalent to $Disgren^{TM}$ capsule.

• The Korean Journal of Pain
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• v.22 no.2
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• pp.146-150
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• 2009

Background: A skin temperature difference is one of the variables used in the diagnosis of complex regional pain syndrome. However, there have been no reports as to whether the real (${\Delta}T$) or absolute value ($|{\Delta}T|$) of skin temperature differences should be used in the diagnosis of complex regional pain syndrome. This study was conducted to compare the diagnostic validity of ${\Delta}T$ with $|{\Delta}T|$ for complex regional pain syndrome using receiver operating characteristic curves (ROC). Methods: Infrared thermographic images were obtained from the 144 patients who were suspected to have CRPS in a unilateral limb. After ${\Delta}T$ and $|{\Delta}T|$ calculation from the thermographic image, ROCs of ${\Delta}T$ and $|{\Delta}T|$ were developed, and the areas under the curve (AUC) for the ROC curves were compared. Results: AUCs of ${\Delta}T$ and $|{\Delta}T|$ were 0.520 and 0.746 respectively, this difference was statistically significant (P < 0.001). Conclusions: Absolute skin temperature difference shows greater validity in the diagnosis of CRPS than ${\Delta}T$. Therefore, $|{\Delta}T|$ is more useful when comparing the skin temperature of CRPS patients.

• Journal of the Korean Burn Society
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• v.22 no.2
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• pp.38-44
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• 2019

Purpose: The immature granulocyte count has been reported to be a marker of infection and sepsis. The difference in leukocyte subfractions (delta neutrophil index, DNI) in ADVIA 2120 reflects the fraction of circulating immature granulocytes in the blood. This study evaluated the clinical utility of DNI as a severity and prediction marker in critically ill patients with burn sepsis. Methods: One hundred and sixty nine patients admitted to the burn care unit were studied. DNI (the difference in leukocyte subfractions identified by myeloperoxidase and nuclear lobularity channels) was determined using a specific blood cell analyzer. Results: Seventy one patients (42 %) were diagnosed with burn sepsis. DNI was significantly higher in patients with burn sepsis than in patients without (P<0.01). Delta neutrophil index was a better indicator of burn sepsis than C-reactive protein, lactate, white blood cell count, HCO3, base excess, lactate, procalcitonin (odds ratio, 6.31; confidence interval 2.36~16.90; P<0.01). And the receiver operating characteristic curves showed that delta neutrophil index, AUC 0.795 (95% confidence interval, 0.721~0.869; P<0.05) was a better predictor of burn sepsis than lactate, procalcitonin, white blood cell, base excess and abbreviated burn severity index. Conclusion: Delta neutrophil index may be used as a early marker of patients with burn sepsis.

• Korean Journal of Clinical Pharmacy
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• v.7 no.2
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• pp.67-72
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• 1997

The bioequivalence of two lomefloxacin tablets was evaluated in 16 normal male volunteers (age $21\sim30$ yrs) following oral administration. Test product was 'Lomaxacin tablet' made by Kolon Pharmaceutical Co. and reference product was 'Maxaquin tablet' made by Searle Ciba-Geigy Korea Co. After one tablet containing 400 mg of lomefloxacin was administered, blood was taken at predetermined time intervals and the concentration of the drug in plasma was determined with an HPLC method using fluorescence detector. AUC, $C_{max},\;and\;T_{max}$ were calculated and statistically analyzed for the bioequivalence of the two products. The results showed that the differences in AUC, $C_{max},\;and\;T_{max}$ between two products were $0.90\%,\;1.09\%,\;and\;2.44\%$, respectively. The powers (1-${\beta}$) for AUC, $C_{max},\;and\;T_{max}\;were\;>95\%,\;>95\%,\;and\;93.8\%$, respectively Detectable differences $(\Delta)$ and confidence intervals were all less than $20\%$. All of these parameters met the criteria of KFDA for bioequivalence, indicating that 'Lomaxacin tablet' is bioequivalent to 'Maxaquin tablet'.

• Archives of Pharmacal Research
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• v.13 no.2
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• pp.180-186
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• 1990

A bioequivalence study of ranitidine tablets was conducted according to the Korean Guidine for the Bioequivalence Test using twelve healthy male subjects. The plasma concentration-timecurves of ranitidine from the test and reference tablets showed profound multiple peak phenomenon in each subject as reported earlier. However, the area under the plasma concentration-time curve (AUC) and the maximum ploasma concentration at the first peak ($C_{max1}$) of the two preparations was proven to be equal when analyzed satistically according to the criteria of the guidline;i. e., statistical power (1-$\beta$)was calculated to be over 0.8 under the condition of $\alpha$ = 5% and $\Delta$(minimum detectable difference) = 20%, and the confidence interval of the difference in AUC at 95% confidence level was in the range of $\pm$ 20%, which statisfied the criteria of bioequivalence. Equivalence of the peak concentration of ranitidine at the second peak ($C_{max2}$), and the time to reach the first ($T_{max1}$) and second verify the bioequivalence of $c_{max2}$ , $T_{max1}$ and $T_{max2}$ between the two tablets. However, we conclude that the test and reference tablets are bioequivalent taking the therapeutic characteristics of the ranitidine preparations into consideration.

• The Korea Journal of Herbology
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• v.29 no.3
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• pp.59-70
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• 2014

Objectives : The purpose of this study was to evaluate boiled rice made from unpolished rice, Job's Tears, and extract from medicinal herbs mixture (HGMCJE) for hypoglycemic effect on STZ-induced diabetic rats. Methods : In the response of glucose tolerance, control and diabetic rats groups was intubated with glucose and HGMCJE. Furthermore, boiled 100% polished rice (P rice), boiled unpolished rice mixed with white rice and Job's tears (polished rice:unpolished rice:Job's tears=60:25:15, UPJ-rice), and UPJ rice made from HGMCJE (HUPJ-rice) were intubated to control and diabetic rats groups, respectively. Then, blood glucose concentration, incremental blood glucose, and area under the curve (${\Delta}AUC$) were analyzed in every experimental groups, and these data were used to evaluate glycemic response. Results : When glucose and p rice were intubated in control and diabetic rats, blood glucose concentration, incremental blood glucose, and incremental response ${\Delta}AUC$ of diabetic groups were significantly increase than control groups. But administraion of a single dose of extract from medicinal herbs mixture and HUPJ-rice in control and diabetic rats inhibited the remarkable increase the level of postprandial blood and ${\Delta}AUC$ at 60, 90, and 120 min Conclusions : These results indicate that when intubation of glucose and P rice were out of control on postprandial glycemic response in diabetic rats. But postprandial glycemic response was well-modulated by administrating a single oral dose of HGMCJE and HUPJ-rice. Therefore, HGMCJE can be developed as an effective hypoglycemic agent.

• Journal of Pharmaceutical Investigation
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• v.29 no.1
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• pp.61-66
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• 1999

Bioequivalence of two terazosin tablets, the $Hytrine^{TM}$ (Il-Yang Pharmaceutical Co., Ltd.) and the $Hytrine^{TM}$ (Daewon Pharmaceutical Co., Ltd.), was evaluated according to the guideline of KFDA. Sixteen normal male volunteers $(21{\sim}30\;years\;old)$ were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After one tablet containing 2 mg of terazosin was orally administered, blood was taken at predetermined time intervals and the concentration of terazosin in serum was determined with a HPLC method using spectrofluorometric detector. The pharmacokinetic parameters $(AUC_t,\;C_{max}\;and\;T_{max})$ were calculated and ANOVA was utilized for the statistical analysis of the parameters. The results showed that the differences in $AUC_t$ $C_{max}$ and $T_{max}$ between two tablets were 6.02%,3.44% and -3.67%, respectively. The powers $(1-{\beta})$ for $AUC_t$, $C_{max}$ and $T_{max}$ were 98.05%, 98.34% and 29.81 %, respectively. Detectable differences $({\Delta})$ and confidence intervals were all less than ${\pm}20%$ except $T_{max}$. $AUC_t$ and $C_{max}$ met the criteria of KFDA for bioequivalence, indicating that $Terasin^{TM}$ tablet is bioequivalent to $Hytrine^{TM}$ tablet.

• 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.

• The Journal of Advanced Prosthodontics
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• v.9 no.6
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• pp.432-438
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• 2017

PURPOSE. The purpose of this study was to evaluate the in vitro validity of quantitative light-induced fluorescence-digital (QLF-D) and laser fluorescence (DIAGNOdent) for assessing proximal caries in extracted premolars, using digital radiography as reference method. MATERIALS AND METHODS. A total of 102 extracted premolars with similar lengths and shapes were used. A single operator conducted all the examinations using three different detection methods (bitewing radiography, QLF-D, and DIAGNOdent). The bitewing x-ray scale, QLF-D fluorescence loss (${\Delta}F$), and DIAGNOdent peak readings were compared and statistically analyzed. RESULTS. Each method showed an excellent reliability. The correlation coefficient between bitewing radiography and QLF-D, DIAGNOdent were -0.644 and 0.448, respectively, while the value between QLF-D and DIAGNOdent was -0.382. The kappa statistics for bitewing radiography and QLF-D had a higher diagnosis consensus than those for bitewing radiography and DIAGNOdent. The QLF-D was moderately to highly accurate (AUC = 0.753 - 0.908), while DIAGNOdent was moderately to less accurate (AUC = 0.622 - 0.784). All detection methods showed statistically significant correlation and high correlation between the bitewing radiography and QLF-D. CONCLUSION. QLF-D was found to be a valid and reliable alternative diagnostic method to digital bitewing radiography for in vitro detection of proximal caries.

• Korean Journal of Clinical Pharmacy
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• v.7 no.2
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• pp.73-80
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• 1997

The bioequivalence of two loxoprofen tablets between the $Loxonin^{TM}$ (Dong Hwa Pharmaceutical Co., Ltd.) and the $Lokpen^{TM}$ (Dong Il Pharmaceutical Co., Ltd.) was evaluated. 12 normal male volunteers (age $21\sim27$ years old) were divided into two groups and a randomized cross-over study was employed. After one tablet containing 60 mg of loxoprofen sodium anhydrous was orally administered, blood was taken at predetermined time intervals and the concentration of loxoprofen in serum was determined with an HPLC method using UV/VIS detector. The pharmacokinetic parameters ($C_{max},\;T_{max}$, and $AUC_t$) were calculated and ANOVA was utilized for the statistical analysis of parameters. The results showed that the differences in $C_{max},\;T_{max}$, and $AUC_t$ between two tablets were $1.13\%,\;0\%,\;and\;0.69\%$, respectively The powers (1-${\beta}$) for $C_{max},\;T_{max}$, and $AUC_t$ were $84.88\%,\;88.61\%,\;and\;84.81\%$, respectively Detectable differences ($\delta$) and confidence intervals were all less than $20\%$. All of these parameters met the criteria of KFDA for bioequivalence, indicating that $Lokpen^{TM}$ tablet is bioequivalent to $Loxonin^{TM}$ tablet.