• Title/Summary/Keyword: Clinical guideline

Search Result 842, Processing Time 0.042 seconds

Determination of Terazocin in Human Plasma by Liquid Chromatography and Bioequivalence Study of Teratonin® Tablets (액체크로마토그래프법에 의한 사람 혈장 중 테라조신의 정량 및 테라토닌® 정의 생물학적 동등성)

  • Cho, Eun-Sook;Kang, Sung-Ha;Chun, In-Koo
    • Journal of Pharmaceutical Investigation
    • /
    • v.32 no.2
    • /
    • pp.119-125
    • /
    • 2002
  • A rapid, selective and reproducible high-performance liquid chromatographic method has been developed for the determination of terazocin in human plasma. Terazocin plus the internal standard, prazocin hydrochloride, were extracted from alkalified plasma with tert-butylmethyl ether, back-extracted into 0.05% phosphoric acid. Fifty ${\mu}l-portions$ of extract were injected onto a octadecylsilane column and eluted with a mixture of acetonitrile, water and triethylamine (30 : 70 : 0.1 v/v, adjusted to pH 5.0 with dilute phosphoric acid) at a flow rate of 1.0 ml/min. The fluorescence intensity of column eluents was monitored at excitation wavelength of 250 nm and emission wavelength of 370 nm. No interference peaks were observed. The practical limit of quantitation was 5 ng/ml for terazocin. The average intraday and interday coefficients of variation were 4.15 and 3.54%, respectively. Also intraday and interday precisions over the range $5{\sim}60\;ng/ml$ were $0.49{\sim}2.92\;and\;0.38{\sim}5.12%$, respectively. The bioequivalence of two terazosin tablets, the $Hytrine^{\circledR}$ (Il Yang Pharmaceutical Co., Ltd.) and the $Teratonin^{\circledR}$ (Sam-A Pharmaceutical Co., Ltd.), was evaluated according to the guideline of Korea Food and Drug Administration (KFDA). Sixteen healthy male volunteers $(24.6{\pm}2.0\;years\;old)$ 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 plasma was determined with a HPLC method using spectrofluorometric detector. AUC was calculated by the linear trapezoidal method. $C_{max}\;and\;T_{max}$ were compiled from the plasma drug concentration-time data. Analysis of variance (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 the two preparations were 0.21 %, 5.53% and 8.82%, respectively. The powers $(1-{\beta})\;for\;AUC_t,\;C_{max}\;and\;T_{max}$ were >99%, 97.49%, and 33.26%, respectively. Minimum detectable differences $({\Delta},\;%)\;at\;{\alpha}=0.1\;and\;1-{\beta}=0.8$ and the 90% confidence intervals were all less than ${\pm}20%$ except for $T_{max}.\;AUC_t\;and\;C_{max}$ met the criteria of KDFA for bioequivalence, indicating that $Teratonin^{circledR}$ tablets are bioequivalent to $Hytrine^{circledR}$ tablets.

Bioequivalence of Traline Tablet to Zoloft® Tablet (Sertraline HCI 50 mg)

  • Kang, Hyun-Ah;Cho, Hea-Young;Lee, Yong-Bok
    • Journal of Pharmaceutical Investigation
    • /
    • v.41 no.5
    • /
    • pp.317-322
    • /
    • 2011
  • Sertraline HCl, (1S-cis)-4-(3, 4-dichloro-phenyl)-1, 2, 3, 4-tetrahydro-N-methyl-l-naphthalenamine hydrochloride, is a potent and selective serotonin reuptake inhibitor which is used in the treatment of depression and obsessivecompulsive disorders. The purpose of the present study was to evaluate the bioequivalence of two sertraline HCl tablets, Traline tablet (Myungin Pharm. Co. Ltd.) and Zoloft$^{(R)}$ tablet (Pfizer Inc.), according to the guidelines of the Korea Food and Drug Administration (KFDA). The in vitro release of sertraline from the two sertraline HCl formulations was tested using KP VIII Apparatus II method with various dissolution media. Twenty four healthy Korean male volunteers, $23.50{\pm}1.74$ years in age and $64.09{\pm}7.10\;kg$ in body weight, were divided into two groups and a randomized $2{\times}2$ crossover study was employed. After a single tablet containing 50 mg as sertraline HCl was orally administered, blood samples were taken at predetermined time intervals and the concentrations of sertraline in serum were determined using an online columnswitching HPLC method with UV/Vis detection. The dissolution profiles of two formulations were similar in all tested dissolution media. The pharmacokinetic parameters such as $AUC_t$, $C_{max}$ and $T_{max}$ were calculated, and computer programs (Equiv Test and K-BE Test) were utilized for the statistical analysis of the parameters using logarithmically transformed $AUC_t$, $C_{max}$ and un-transformed $T_{max}$. The results showed that the differences between two formulations based on the reference drug, Zoloft$^{(R)}$ tablet, were 0.04, 3.26 and -1.29% for $AUC_t$, $C_{max}$, and $T_{max}$, respectively. There were no sequence effects between two formulations in these parameters. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of log0.8 to log1.25. Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating Traline tablet was bioequivalent to Zoloft$^{(R)}$ tablet.

Bioequivalence of Hana Loxoprofen Sodium Tablet to Dongwha Loxonin® Tablet (Loxoprofen Sodium 60 mg)

  • Kang, Hyun-Ah;Cho, Hea-Young;Lee, Yong-Bok
    • Journal of Pharmaceutical Investigation
    • /
    • v.41 no.2
    • /
    • pp.117-123
    • /
    • 2011
  • Loxoprofen sodium, a 2-phenylpropionate non-steroidal anti-inflammatory drug (NSAID), has marked analgesic and antipyretic activities and relatively weak gastrointestinal ulcerogenicity. The purpose of the present study was to evaluate the bioequivalence of two loxoprofen sodium tablets, Hana loxoprofen sodium tablet (Hana Pharm. Co., Ltd.) and Dongwha Loxonin$^{(R)}$ tablet (Dongwha Pharm. Co., Ltd.), according to the guidelines of the Korea Food and Drug Administration (KFDA). The in vitro release of loxoprofen from the two loxoprofen sodium formulations was tested using KP IX Apparatus II method with various dissolution media. Twenty four healthy Korean male volunteers, $22.83{\pm}1.862$ years in age and $69.92{\pm}9.14$ kg in body weight, were divided into two groups and a randomized $2{\times}2$ crossover study was employed. After a single tablet containing 60 mg as loxoprofen sodium was orally administered, blood samples were taken at predetermined time intervals and the concentrations of loxoprofen in serum were determined using a online column-switching HPLC method with UV/Vis detection. The dissolution profiles of two formulations were similar in all tested dissolution media. The pharmacokinetic parameters such as $AUC^t$, $C_{max}$ and $T_{max}$ were calculated, and computer programs (Equiv Test and K-BE Test 2002) were utilized for the statistical analysis of the parameters using logarithmically transformed $AUC_t$, $C_{max}$ and un-transformed $T_{max}$. The results showed that the differences between two formulations based on the reference drug, Dongwha Loxonin$^{(R)}$ tablet, were 2.03, 2.99 and -9.49% for $AUC_t$, $C_{max}$, and $T_{max}$, respectively. There were no sequence effects between two formulations in these parameters. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of log0.8 to log1.25 (e.g., log0.9831~log1.0535 and log0.9455~log1.1386 for $AUC_t$ and $C_{max}$, respectively). Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating Hana loxoprofen sodium tablet was bioequivalent to Dongwha Loxonin$^{(R)}$ tablet.

The Progress Report of Weight and Waist Circumference through the Oriental Obesity Treatment (한방비만프로그램을 통한 체중과 부위별 복부둘레의 경과 관찰 및 상관성 연구)

  • Heo, Su-Jeong;Ie, Jae-Eun;Kim, Hyun-Jin;Cho, Hyun-Ju;Myoung, Sung-Min
    • Journal of Korean Medicine for Obesity Research
    • /
    • v.9 no.2
    • /
    • pp.47-56
    • /
    • 2009
  • Objectives The purpose of this study was to investigate the progress of weight and waist circumference(WC) through oriental obesity treatment and clarify the correlation between weight loss and WC change. Methods The subjects were treated from January 2007 to September 2009 in J Oriental Medical Center. Herbal medicine, electroacupuncture, oriental obesity physiotherapy were performed for a month. We checked the change of weight and WC at every treatment. We classified the WC into upper, middle, lower parts specifically and measured them individually. Measurements were analyzed by using one-way repeated measures ANOVA and we also investigated correlation between weight loss and WC change. Results (1) During the first and second treatment sessions, the weight loss was the highest, $0.96{\pm}0.86\;kg$($1.46{\pm}1.32\;%$) and during the 5th and 6th treatment sessions, the lowest $0.37{\pm}0.616\;kg$. The final weight loss was $3.71{\pm}1.476\;kg$($5.51{\pm}2.12\;%$). (2) After 8 treatment sessions, the reductions of upper, middle and lower WC were $3.59{\pm}2.26\;%$, $5.93{\pm}2.75\;%$, $5.51{\pm}3.22\;%$, respectively. As the patients received more treatment, there was a progressive decline in the variation of weight and middle WC. However, the decline rate of upper and middle WC fluctuated during the treatments, forming a W-shaped curve. (3) Analysis of the correlation between the weight loss and WC change shows that the reduction of middle WC was most closely associated with the weight loss. Conclusions This study indicated that the rate of weight loss and WC reduction showed stagnation during the 5th and 6th treatment sessions, and the reduction of middle WC was most closely associated with the weight loss. Since the progress of weight and WC change is an important field of research on obesity, further systemic studies would be needed for the foundation of a clinical guideline.

  • PDF

Efficacy of $M+\;Parapac^{(R)}$ on protection against PMWS with $Gl{\ddot{a}}sser's$ disease (국내 양돈장에서 돼지글래셔병을 동반한 PMWS에 대한 M+ $Parapac^{(R)}$의 방어효과)

  • Ahn, Na-Kyoung;Seo, Tae-Won;Jeong, Hyun-Kyu;Yoon, Byung-Il;Han, Jeong-Hee
    • Korean Journal of Veterinary Service
    • /
    • v.31 no.3
    • /
    • pp.347-356
    • /
    • 2008
  • The purpose of this study was to evaluate the efficacy and cross-protection of serovar 12 against serovar 4 or 5 of H parasuis with M+$Parapac^{(R)}$. A total of 141 piglets from 2(A and B) farms were used and divided into experimental group and control group in each farm. Farm A has been detected H parasuis serovar 12, whereas farm B has been detected H parasuis serovar 4 or 5 from post-weaned pigs with PMWS. The piglets were vaccinated intramuscularly with 2.0ml of M+$Parapac^{(R)}$ in experimental group or normal saline in control group at 1 week of age. A same booster dose was given at 3 weeks of age. In order to value the antibody titer to H parasuis using by tube agglutination test, blood samples were collected from piglets at the aged of 1 week, 6 and 14 weeks. In experimental group and control group, the average antibody titers were $32.5{\pm}21.0,\;114.5{\pm}34.0,\;98.1{\pm}55.4$ and $32.9{\pm}18.6,\;25.8{\pm}36.9,\; 746.7{\pm}1,215.8$ at the aged of 1 week, 6 and 14 weeks, respectively. The cumulative clinical sign indexes by standard guideline of Schering-Plough Animal Health Corp were 486 and 1,069, respectively. The average daily gains and feed conversion rates were $0.553{\pm}0.016kg$ and $0.492{\pm}0.004kg$, and 1.99 and 2.24, respectively. The average gross lesion scores were $1.0{\pm}0.8$ and $1.9{\pm}0.6$, respectively. According to these results, the M+$Parapac^{(R)}$ containing H parasuis serovar 12 may be induce circulating antibodies that cross-react with serovar 4 or 5 and have a protection of PMWS with H parasuis.

Does Process Quality of Inpatient Care Serve as a Guide to Reduce Potentially Preventable Readmission (PPR)? (의료서비스의 과정적 질과 잠재적으로 예방 가능한 재입원율과의 관계)

  • Choi, Jae-Young
    • Korea Journal of Hospital Management
    • /
    • v.23 no.1
    • /
    • pp.87-106
    • /
    • 2018
  • Objective: The objective of this study is to examine the association between process quality of inpatient care and risk-adjusted, thirty-day potentially preventable hospital readmission (PPR) rates. Data Sources/Study Setting: This was an observational cross-sectional study of nonfederal acute-care hospitals located in two states California and Florida, discharging Medicare patients with a principal discharge diagnosis of heart failure, acute myocardial infarction, or pneumonia January through December 31, 2007. Data were obtained from the Healthcare Cost and Utilization Project State Inpatient Database of the Agency for Healthcare Research and Quality, Centers for Medicare and Medicaid Services Hospital Compare database, and the American Hospital Association Annual Survey of Hospitals. Study Design: The dependent variable of this study is condition-specific, risk-adjusted, thirty-day potentially preventable hospital readmission (PPR). 3M's PPR software was utilized to determine whether a readmission was potentially preventable. The independent variable of this study is hospital performance for process quality of inpatient care, measured by hospital adherence to recommended processes of care. We used multivariate hierarchical logistic models, clustered by hospitals, to examine the relationship between condition-specific, risk-adjusted, thirty-day PPR rates and process quality of inpatient care, after taking clinical and socio-demographic characteristics of patients and structural and operational characteristics of hospitals into account. Findings: Better performance on the process quality metrics was associated with better patient outcome (i.e., low thirty-day PPR rates) in pneumonia, but not generally in two cardiovascular conditions (i.e., heart failure and acute myocardial infarction). Practical Implication: Adherence to the process quality metrics currently in use by CMS is associated with risk-adjusted, thirty-day PPR rates for patients with pneumonia, but not with cardiovascular conditions. More evidence-based process quality metrics closely linked to 30-day PPR rates, particularly for cardiovascular conditions, need to be developed to serve as a guideline to reduce potentially preventable readmissions.

Evaluation of Stability in the Purified Wood Vinegar and Its Hair Growth Effect (목초액의 안정성 및 모발 성장 촉진 효과)

  • Cho, Young-Ho;Lee, Ju-Yeon;Lee, Jong-Hwa;Cho, Jae-Su;Lee, Gye-Won
    • Journal of Life Science
    • /
    • v.19 no.10
    • /
    • pp.1389-1395
    • /
    • 2009
  • Generally, it takes a long time to purify wood vinegar, and it contains toxic compounds such as tar, methanol, phenol and benzopyrene. To reduce the toxicity of wood vinegar itself, we have developed a new purification method of wood vinegar using an oxidation-cohesion reaction and distillation with an active carbon. We have investigated the physico-chemical change (pH, specific gravity, refractive index and dissolved tar), the change of amount of toxic compounds (carbonyl group, phenol, benzopyrene and residual solvents) and organic acids (formic acid (FA), acetic acid (AA), propionic acid (PA)) of the purified wood vinegar under the long term and accelerated storage conditions. Also, we have evaluated the effect of the purified wood vinegar on hair growth using an alopecia model of C57BL/6 mice. As a result, we could find out that the purified wood vinegar was stable and remained without decay under the storage conditions and benzopyrene, a carcinogenic agent, was not detected in the purified wood vinegar. After topical treatment of the purified wood vinegar solution or minoxidil (MXD) for 2 weeks to dorsal skin, the hair regrowth of the mice accelerated faster than that of the control, with no clinical signs. In conclusion, we could suggest a guideline for quality control of process to reduce the toxic compounds in wood vinegar and it might be a useful hair growth promoter in the treatment of baldness or alopecia.

Development of portable digital radiography system with device for sensing X-ray source-detector angle and its application in chest imaging (엑스선촬영 각도를 측정할 수 있는 장치 개발과 흉부 X선 영상촬영에서의 적용)

  • Kim, Tae-Hoon;Heo, Dong-Woon;Ryu, Jong-Hyun;Jeong, Chang-Won;Jun, Hong Young;Kim, Kyu Gyeom;Hong, Jee Min;Jang, Mi Yeon;Kim, Dae Won;Yoon, Kwon-Ha
    • Proceedings of the Korean Society of Computer Information Conference
    • /
    • 2017.01a
    • /
    • pp.235-238
    • /
    • 2017
  • This study was to develop a portable digital radiography (PDR) system with a function measuring the X-ray source-with-detector angle (SDA) and to evaluate the imaging performance for the diagnosis of chest imaging. The SDA device consisted of an Arduino, an accelerometer and gyro sensor, and a Bluetooth module. According to different angle degrees, five anatomical landmarks on chest images were assessed using a 5-point scale. Mean signal-to-noise ratio and contrast-to-noise ratio were 182.47 and 141.43. Spatial resolution (10% MTF) and entrance surface dose were 3.17 lp/mm ($157{\mu}m$) and 0.266mGy. The angle values of SDA device were not significant difference as compared to those of the digital angle meter. In chest imaging, SNR and CNR values were not significantly different according to different angle degrees (repeated-measures ANOVA, p>0.05). The visibility scores of the border of heart, 5th rib and scapula showed significant differences according to different angles (rmANOVA, p<0.05), whereas the scores of the clavicle and 1st rib were not significant. It is noticeable that the increase in SDA degree was consistent with the increase of visibility score. Our PDR with SDA device would be useful to be applicable to clinical radiography setting according to the standard radiography guideline at various fields.

  • PDF

A Study on Organophosphate Poisoning Patients: Comparison of the Survivor Group and Dead Group (생존군과 사망군의 비교 분석을 통한 유기인계 살충제 중독환자에 대한 연구)

  • Choi, Youn-Gyu;Lee, Dong-Hyeon;Kim, Woo-Hyung;Lee, Gang-Wook;Kim, Sun-Pyo;Kim, Seong-Jung;Cho, Soo-Hyung;Cho, Nam-Soo
    • Journal of The Korean Society of Clinical Toxicology
    • /
    • v.8 no.1
    • /
    • pp.16-23
    • /
    • 2010
  • Purpose: Organophosphate insecticide poisoning is common in Korea, but there is no definitive guideline for determining the severity of the poisoning and the predictive factors. Therefore, we evaluated the organophosphate poisoned patients and we divided them into two groups, the survivors and the dead, and the results might be useful for treating organophosphate poisoning patients. Methods: We performed a retrospective analysis of 68 organophosphate poisoned patients who visited the Chosun University Hospital Emergency Medical Center during a 24-month period from January, 2007 to December, 2008. We made a work sheet of the patients' characteristics and the collected data was analyzed and we compared this data between the survivor group and the dead patient group. Results: There were significant differences between the survivor group and the dead patient group for the mean age, the alcohol intake state and the typically expressed signs. The dead patients had lower blood pressure, tachycardia and a lower Glasgo Coma Score (GCS) score than the survivor group. On the arterial blood gas analysis, the dead patients had more severe acidemia and they had lower saturations. Increased serum amylase levels were found in the dead patients. The survivors'initial and follow up serum pseudocholinesterase activity (after 6~8 days) was significantly higher than that of the dead group. The total amount of atropine injected to patient was less in the survivors than that in the dead patients. Conclusion: Old age and expressing the typical intoxication signs, a lower GCS score and blood pressure, showing acidosis on the gas analysis and low serum cholinesterase activity may be useful as poor prognostic indicators for patients with organophosphate poisoning. We suggest that physicians must pay careful attention to the signs and prognostic factors of organophosphate insecticide poisoned patients.

  • PDF

Evaluation of Image Quality by Parameter Change in Onco Flash (Onco Flash에서 매개변수 변화에 따른 영상의 질 평가)

  • Cha, Eun-Sun;Noh, Ik-Sang;Kim, Ki;Choi, Choon-Ki;Seok, Jae-Dong
    • The Korean Journal of Nuclear Medicine Technology
    • /
    • v.13 no.1
    • /
    • pp.30-34
    • /
    • 2009
  • Purpose: Many companies developed a lot of programs with continuous effort for program upgrading. With this acquire superior image quality for the purpose of quick examination and progress in spatial resolution. This study was to obtained clinical usefulness on a appropriate parameter of FWHM for speed and alpha value for superior image quality. Materials and Methods: Gamma camera by Siemens (e.cam) and spatial resolution phantom and four quadrant bar phantom used. Compared for FWHM by changed scan speed 15, 20, 25, 30, 35, 40 cm/min in scatter and non scatter in Onco Flash of spatial resolution phantom. Visual evaluation of count rate and bar phantom image for increased of alpha value of 10% in 0~100%. Results: FWHM by the scan speed was 9.37, 9.40, 9.28, 9.30, 9.31, 9.53 mm in the scatter. Count rate increased alpha value 10% increased. Visual evaluation was suitable to below 30%, Therefore spatial resolution improved on FWHM at the scan speed 25~35 cm/min applying for alpha value 30% in Onco Flash was average 9.3 mm less than FWHM of below 15 cm/min and above 40 cm/min. Conclusion: We found on appropriate parameter to progress of image quality. And there be a useful guideline for you that appropriate scan speed on vary in parameters of reduction on examination time and advancing image quality.

  • PDF