• Journal of Pharmaceutical Investigation
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• v.36 no.3
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• pp.201-207
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• 2006

Acetaminophen (paracetamol), a para-aminophenol derivative, has analgesic and antipyretic properties and weak anti-inflammatory activity. The purpose of the present study was to evaluate the bioequivalence of two acetaminophen tablets, $Tylenol^{\circledR}$ ER (Janssen Korea Ltd.) and Tylicol ER (Hana Pharmaceutical Co., Ltd.), according to the guidelines of the Korea Food and Drug Administration (KFDA). The release of acetaminophen from the two acetaminophen formulations in vitro was tested using KP VIll Apparatus II method with pH 1.2 buffer solution. Twenty six healthy male subjects, $22.8{\pm}1.99$ years in age and $65.6{\pm}8.03$ kg in body weight, were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After a single tablet containing 650 mg as acetaminophen was orally administered, blood samples were taken at predetermined time intervals and the concentrations of acetaminophen in serum were determined using HPLC with UV detector. The dissolution profiles of two formulations were similar in pH 1.2 buffer solution. 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 logarithmically transformed $AUC_t$, $C_{max}$ and untransformed $T_{max}$. The results showed that the differences between two formulations based on the reference drug, $Tylenol^{\circledR}$ ER, were 2.84, 1.89 and -1.36% 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 log 0.8 to log 1.25 (e.g., log $0.987{\sim}log$ 1.08 and log $0.944{\sim}log$ 1.17 for $AUC_t$ and $C_{max}$, respectively). Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating Tylicol ER tablet was bioequivalent to $Tylenol^{\circledR}$ ER tablet.

• Journal of Pharmaceutical Investigation
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• v.36 no.2
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• pp.143-148
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• 2006

Finasteride $[N-(1, 1-dimethylethyl)-3-oxo-4-aza-5{\alpha}-androst-1-ene-17{\beta}-carboxamide]$ is a 4-aza-3-oxosteroidal inhibitor of human $5{\alpha}-reductase$. The purpose of the present study was to evaluate the bioequivalence of two finasteride tablets, $Proscar^{\circledR}$ (MSD Korea Ltd.) and Procare (Hana Pharm. Co., Ltd.), according to the guidelines of the Korea Food and Drug Administration (KFDA). The release of finasteride from the two finasteride formulations in vitro was tested using KP VIII Apparatus II method with various dissolution media (pH 1.2, 4.0, 6.8 buffer solution and water). Twenty six healthy male subjects, $23.7\;{\pm}\;2.24$ years in age and $67.2\;{\pm}\;8.55\;kg$ in body weight, were divided into two groups and a randomized $2\;{\time}\;2$ cross-over study was employed. After two tablets containing 5 mg as finasteride was orally administered, blood samples were taken at predetermined time intervals and the concentrations of finasteride in serum were determined using HPLC with UV detector. 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 ANOVA test was utilized for the statistical analysis of the parameters using logarithmically transformed $AUC_t,\;C_{max}$ and untransformed $T_{max}$. The results showed that the differences between two formulations based on the reference drug, $Proscar^{\circledR}$, were 6.39, 4.65 and -13.9% 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 log 0.800 to log 1.25 $(e.g.,\;log\;0.990{\sim}log\;1.14\;and\;log\;0.977{\sim}log\;1.13 for\;AUC_t\;and\;C_{max},\;respectively)$. Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating Procare tablet was bioequivalent to $Proscar^{\circledR}$ tablet.

• Journal of Pharmaceutical Investigation
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• v.36 no.1
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• pp.67-73
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• 2006

Lornoxicam is a nonsteroidal anti-inflammatory drug that decreases prostaglandin synthesis by inhibiting cyclooxygenase. It has analgesic, antipyretic and antiinflammatory effects. The purpose of the present study was to evaluate the bioequivalence of two lornoxicam tablets, $Xefo^{\circledR}$ (Hyundai Pharmaceutical Ind. Co., Ltd.) and Lornocam (Samchundang Pharmaceutical Co., Ltd.), according to the guidelines of the Korea Food and Drug Administration (KFDA). The release of lornoxicam from the two lornoxicam formulations in vitro was tested using KP VIII Apparatus II method with various dissolution media (pH 1.2, 4.0, 6.8 buffer solution and water). Twenty eight healthy male subjects, $24.39{\pm}1.95$ years in age and $68.63{\pm}7.25$ kg in body weight, were divided into two groups and a randomized $2\;{\time}\;2$ cross-over study was employed. After a single tablet containing 4 mg as lornoxicam was orally administered, blood samples were taken at predetermined time intervals and the concentrations of lornoxicam in serum were determined using HPLC with UV detector. 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 ANOVA test was utilized for the statistical analysis of the parameters using logarithmically transformed $AUC_t,\;C_{max}$ and untransformed $T_{max}$. The results showed that the differences between two formulations based on the reference drug, $Xefo^{\circledR},$ were -1.56%, 2.16% and -17.12% 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 log 0.8 to log 1.25 (e.g., $log\;0.90{\sim}log\;1.05$ and $log\; 0.88{\sim}log\;1.17$ for $AUC_t\;and\;C_{max},$ respectively). Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating Lornocam tablet was bioequivalent to $Xefo^{\circledR}$ tablet.

• Korean Journal of Acupuncture
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• v.37 no.2
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• pp.76-87
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• 2020

Objectives : Bee venom has been widely practiced in many countries around the world. The number of clinical trials and biochemical researches on bee venom has been constantly increasing. The objective of this study is to analyze the trend of research on bee venom using bibliometric approach, a quantitative analytical method. Methods : We searched articles about bee venom which were published from 2000 to 2019 from Web of Science Database. Original and review articles published in English were included and data were extracted in terms of publication year, country, journal, keywords, organizations, and authors. Trends in bee venom research were visualized using VOSviewer program. Results : 1,547 English articles about bee venom were identified and analyzed. South Korea is a main hub in the field of bee venom research. Research organizations in South Korea showed high link strength with domestic organizations as well as with international organizations. A keyword analysis showed the following three major types of studies: studies on components of bee venom, studies on allergy and immune response, and clinical research of bee venom therapy. Conclusions : This study provides a macroscopic overview of the research on bee venom. This bibliometric analysis has identified influential authors and organizations in the field on bee venom research and provides a useful guideline to researchers who are in search of contributory research topics.

• The Journal of the Society of Korean Medicine Diagnostics
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• v.19 no.2
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• pp.91-100
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• 2015

Objectives The aim of this study is to develop a structured clinical protocol related with acquisition of radial pulse wave in the randomized, $2{\times}2$ cross-over design, and cold-heat intervention trial for a pilot and preliminary study. Methods The protocol was contrived based on wide ranging literature searches for cold-heat intervention experiments and radial pulse diagnoses. Results Sample size of 60 subjects was calculated based on an effect size derived from the previous study designed to detect the pre-post cold-heat differences in the radial pulse. Each subjects will be randomly assigned to the cold (first) to heat (last) group (n=30) or heat (first) to cold (last) group (n=30). All subjects will fill out a case report form and questionnaires related with pattern identification, dietary patterns, sleep quality, and physical activity will be surveyed and used as a secondary outcomes. Safety assessment will be reported at the final stage. Conclusions This protocol will provide an additional reference to future studies related with observation of radial pulse during any interventions and also expect to be used as a guideline for acquisition of reliable radial pulse wave data.

• Journal of Preventive Medicine and Public Health
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• v.41 no.5
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• pp.339-344
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• 2008

Objectives : The objective of this paper is to discuss the importance of obtaining informed consent for conducting epidemiological studies and public health activities, based on the Report of the UNESCO's Working Group on Informed Consent. Methods : The Report of the UNESCO's Working Group on Informed Consent was reviewed and discussed in connection with the ethical considerations of public health activities and epidemiological research. Results : It was at the Nuremberg Trial for the German war criminals of the Second World War that the principle of 'consent' was first stated as a consequence of the medical abuses carried out during the War. As a result of the Trial, the Nuremberg Code came out in 1947. Since then, various international declarations or ethical principles on 'informed consent' have been developed and published. These ethical principles on 'informed consent' have mostly to do with the clinical research that involves human subjects, and not with epidemiological studies and public health activities. However, UNESCO recently issued a comprehensive Report on Informed Consent based on the Universal Declaration on Bioethics and Human Rights adopted in 2005, and this included detailed guidelines on informed consent in epidemiological studies and public health activities. Conclusions : Universal Declaration on Bioethics and Human Rights emphasizes the principle of autonomy to protect the human rights of the human subjects involved in any public health activities and epidemiological research. As a practical guideline, obtaining informed consent is strongly recommended.

• International Journal of Contents
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• v.11 no.2
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• pp.69-73
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• 2015

This study was performed to determine the optimal doses of alfentanil or remifentanil (effect-site concentrations) required to prevent pain and other suffering after abdominal general surgery in ICU patients. A total of 52 general abdominal surgical patients (ASA IIIII) requiring artificial ventilatory care in the ICU were provided with either alfentanil (24 patients) or remifentanil (28 patients) through target controlled infusion (TCI). Alfentanil and remifentanil concentrations were titrated up and down until the pain score became less than 3 (VAS; Visual Analogue Score < 3). The effect-site concentrations (ng/ml) of alfentanil or remifentanil required to adequately control postoperative pain in the ICU were 64 +/- 12 and 1.9 +/- 0.5 for intubation with artificial ventilation, 57 +/- 9 and 1.7 +/- 0.7 for intubation with spontaneous ventilation, and 41 +/- 10 and 1.2 +/- 0.5 after extubation, respectively. Pain scores and the corresponding opioid concentrations were independent from respiratory condition. The three effect-site concentrations of alfentanil and remifentanil obtained from this clinical trial using the TCI technique can be a guideline in the administration of the same opioids to relieve the discomfort of ICU patients who have undergone abdominal general surgery.

• PNF and Movement
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• v.15 no.2
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• pp.115-124
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• 2017

Purpose: Researchers found that blocks of evidence-based practice (EBP) implementation lacked opportunities for EBP education. The study found that physical therapists had negative views of research as well as their roles in EBP, lacked confidence in EBP, and had limited access to web-based materials. The purpose of this study was to highlight the importance of information research technology for efficient EBP in a clinical environment. Methods: The web-based information research technologies that should be used for sustainable EBP include: the clinical practice guideline (CPG) and PubMed's My NCBI service. Journal mailing services and other academic information sources should also be used to gather information from RSS feeds. An EBP library or archive must be created. A site that provides EBP-specific information is also needed. Results: We should usually do EBP. Practitioners must learn and use information technologies that will help them improve their EBP skills. Conclusion: Facilitating EBP implementation and building an EBP system require related education as well as a practical work environment and equipment. However, the highest priority is individual efforts and trial. Information technology will complement the lack of time. It is important to use information research technology to overcome real obstacles. Lasting EBP must use a number of web-based information research technologies to overcome the practical challenges encountered in EBP implementation.

• Journal of Gastric Cancer
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• v.23 no.1
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• pp.3-106
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• 2023

Gastric cancer is one of the most common cancers in Korea and the world. Since 2004, this is the 4th gastric cancer guideline published in Korea which is the revised version of previous evidence-based approach in 2018. Current guideline is a collaborative work of the interdisciplinary working group including experts in the field of gastric surgery, gastroenterology, endoscopy, medical oncology, abdominal radiology, pathology, nuclear medicine, radiation oncology and guideline development methodology. Total of 33 key questions were updated or proposed after a collaborative review by the working group and 40 statements were developed according to the systematic review using the MEDLINE, Embase, Cochrane Library and KoreaMed database. The level of evidence and the grading of recommendations were categorized according to the Grading of Recommendations, Assessment, Development and Evaluation proposition. Evidence level, benefit, harm, and clinical applicability was considered as the significant factors for recommendation. The working group reviewed recommendations and discussed for consensus. In the earlier part, general consideration discusses screening, diagnosis and staging of endoscopy, pathology, radiology, and nuclear medicine. Flowchart is depicted with statements which is supported by meta-analysis and references. Since clinical trial and systematic review was not suitable for postoperative oncologic and nutritional follow-up, working group agreed to conduct a nationwide survey investigating the clinical practice of all tertiary or general hospitals in Korea. The purpose of this survey was to provide baseline information on follow up. Herein we present a multidisciplinary-evidence based gastric cancer guideline.

• Journal of Acupuncture Research
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• v.26 no.3
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• pp.67-80
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• 2009

Objectives : The purpose of this survey is the development on the neck pain for acupuncture and moxibustion clinical guideline. Methods : The survey questionnaire was developed by the committee of experts who major in acupuncture & moxibustion or statistics for acupuncture clinical trial protocol development. The questionnaires were distributed via e-mail to 75 members of Korean Acupuncture & moxibustion society. 57 members completed answers, and the computerized data were analyzed by SPSS 17.0 statistical program. Results and Conclusions : 1. The first selected pattern identification on the neck pain This study shows that the meridian pattern identification was selected 35 times(61.4%), the pattern identification based on cause of disease was selected 8 times(14.0%), the visceral pattern identification was selected 7 times(12.3%), the other pattern identification was selected 4 times(7.0%), Qi blood yin yang pattern identification was selected 2 times(3.5%), according to symptoms was selected 1 time(2.4%). 2. Meridian pattern identification Small intestine meridian of hand Taeyang was used 39 times(18.1%), Large intestine meridian of hand Yangmyeong and Bladder meridian of foot Taeyang was used 34 times(15.7%), Gall-bladder meridian of foot Soyang was 32 times(14.8%), Tripple energizer meridian of hand Soyang was used 31 times(14.4%), Governor meridian was used 30 times(13.9%), Lung meridian of hand Taeeum was used 8 times(3.7%), Heart meridian of hand Soeum and Pericarduim meridian of hand Gworeum was used 4 times(1.9%). 3. Pattern identification based on cause of disease Wind-Cold-Dampness was used 31 times(17.5%), Accumulation of the collateral by Phelgm-Dampness was used 16 times(14.0%), affection by exopathogen Wind-Cold(stiff neck, sprain of cervical) was used 13 times (11.4%), Defecient-Cold was used 10 times(8.8%), affection by exopathogen Wind-Dampness was used 9 times(7.9%), Deep Invasion by Wind-Cold was used 8 times(7.0%), Wind-Cold was used 7 times (6.1%), Wind-Cold was used 6 times(5.3%), Accumulation in the Center by Phelgm-Dampness, Imparement of bou fluid by Pathogenic Heat, Wind-Heat with Dampness was used 5 times(4.4%), affection by exopathogen Wind-Dampness and Accumulation of the collateral by Wind-Cold was used 4 times(3.5%), Invasion of Dampness-Heat was used 2 times(1.8%). 4. Visceral pattern identification Rising of the Liver yang was used 16 times(41%), Yin deficiency of Liver and Kidney+pathogens was used 15 times(38.5%), Yin deficiency of Liver and Kidney was used 8 times(20.5%) on this survey.