• Journal of Pharmaceutical Investigation
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• v.38 no.2
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• pp.135-142
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• 2008

The present study describes the evaluation of the bioequivalence of two atorvastatin tablets, Lipitor $Tablet^{(R)}$ (Pfizer, reference drug) and Atorva $Tablet^{(R)}$ (Yuhan, test drug), according to the guidelines of Korea Food and Drug Administration (KFDA). Forty-nine healthy male Korean volunteers received each medicine at the atorvastatin dose of 40 mg in a $2{\times}2$ crossover study with a two weeks washout interval. After drug administration, serial blood samples were collected at a specific time interval from 0-48 hours. The plasma atorvastatin concentrations were monitored by an high performance liquid chromatography -tandem mass spectrometer (LC-MS/MS) employing electrospray ionization technique and operating in multiple reaction monitoring (MRM) and positive ion mode. The total chromatographic run time was 4.5 min and calibration curves were linear over the concentration range of 0.1-100 ng/mL for atorvastatin. The method was validated for selectivity, sensitivity, linearity, accuracy and precision. $AUC_t$ (the area under the plasma concentration-time curve from time zero to 48hr) was calculated by the linear log trapezoidal rule method. $C_{max}$ (maximum plasma drug concentration) and $T_{max}$ (time to reach $C_{max}$) were complied trom the plasma concentration-time data. Analysis of variance was carried out using logarithmically transformed $AUC_t$ and $C_{max}$. No significant sequence effect was found for all of the bioavailability parameters indicating that the crossover design was properly performed. The 90% confidence intervals of the $AUC_t$ ratio and the $C_{max}$ ratio for Atorva $Tablet^{(R)}$ / Lipitor $Tablet^{(R)}$ were ${\log}\;0.9413{\sim}{\log}\;1.0179$ and ${\log}\;0.831{\sim}{\log}\;1.0569$, respectively. These values were within the acceptable bioequivalence intervals of ${\log}\;0.8{\sim}{\log}\;1.25$. Based on these statistical considerations, it was concluded that the test drug, Atorva $Tablet^{(R)}$ was bioequivalent to the reference drug, Lipitor $Tablet^{(R)}$.

• Korean Journal of Environmental Agriculture
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• v.30 no.3
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• pp.339-345
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• 2011

BACKGROUND: Recently in Korea, the import of agricultural products is rising due to the increasing amount of trade. Unregistered pesticides, allidochlor, propachlor, propham, cycloate, diallate and pebulate are widely used as pesticides for rice cultivation in foreign countries, while they are not registered in Korea. Therefore, the residue amount of imported agri-foods should be verified using the proper official analytical method for each of them that has not registered in Korea. METHODS AND RESULTS: This work was conducted to apply the official method of Korea Food & Drug Administration (KFDA) for determining multi class pesticide multiresidues in agricultural commodities. Brown rice and orange which have different characteristics as a matrix were selected as representative samples for residue analysis. The recoveries of cycloate, diallate and pebulate by GC/MS in fortified brown rice and orange with levels of 0.04~0.4 mg/kg were ranged from 82.8% to 110.3%. The quantification limits of three pesticides in brown rice and orange were 0.04 mg/kg. CONCLUSION: As a result, this method can surely be used as an official method for routine analysis of unregistered pesticides in Korea for imported agri-food.

• The Korean Journal of Pesticide Science
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• v.15 no.1
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• pp.15-21
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• 2011

Monitoring or follow-up surveying pesticide residues in agricultural commodities is the key to meet the international regulations and to enhance international competitiveness of Korean agricultural commodities. Six neonicotinoid insecticides, acctamiprid, clothianidin, dinotefuran, imidacloprid, thiacloprid, and thiamethoxam were monitored in 95 paprika samples collected from Gyeongnam area. Thc pesticide residues were extracted by EN 15662 buffer based on the QuEChERS method, clean-upped with dispersive solid-phase extraction method to remove interfering pigments, and analyzed using UPLC-MS/MS. The neonicotinoid pesticides were detected in 90.5% of the paprika samples. Two or more pesticides were detected in 82.3% of samples. Although detection frequencies were high, all samples complied with the maximum residue limits (MRLs) set by both the Korea Food and Drug Administration (KFDA) and Japanese Ministry of Health, Labour and Welfare.

• The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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• v.26 no.2
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• pp.1-9
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• 2013

Background : According to the rising cases of clinical researches with Traditional Korean Medicine for persistent allergic rhinitis patients, the need for developing and applying Pattern diagnosis instrument has been increasing. Objective : This study was done to investigate and pragmatize the Pattern diagnosis instrument for persistent allergic rhinitis patients launched by KFDA in 2008. Methods : Data was collected by structured survey papers from Korean Medicine doctors participate in the Conference of The Korean Oriental Medical Ophthalmology & Otolaryngology & Dermatology Society in October 2012. We investigated their representative Patterns(변증) of every questions and used the mean results for assuming agreement rates. The importance order of 8 symptom domains for considering Pattern diagnostic steps were also asked and analyzed for inducing importance rates. Finally based on above two results, we developed weight points of each questions by multiplying agrement percents with importance rates. Results : 50 Korean medicine doctors described the informed consent and survey papers. Response agreement rates of each questions of Pattern diagnosis instruments were analyzed and described in Table 2. Comparing the survey results with diagnostic references, matched percent of 肺胃熱 was the 87.9%, 肺氣虛寒 was 62.5%, 肺脾氣虛 was 62.5% and 腎元虧虛 was 50%. Mean importance rates of rhinorrhea was 7.28, otoscope diagnosis 5.12, obstruction 5.04, sneeze 4.82, symptom duration 4.63, other body condition 3.54, tongue diagnosis 3.02, nasal pruritus 2.86, accordingly. Final importance rates of each questions were assumed, and the range of them was from 1.60 to 4.72, which were listed in Table 5. Conclusion : These results might provide the rational backgrounds and practical methods for developing and utilizing methods of Pattern diagnosis questionnaire for perennial allergic rhinitis.

• Journal of Physiology & Pathology in Korean Medicine
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• v.20 no.6
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• pp.1678-1727
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• 2006

This study was perfromed to develop the assessment guideline and endpoints for clinical trial with anticancer herbal medicine. The botanical products used to humans for long time may be applied to phase 3 clinical trial after submitting the evidences for safety and efficacy of them or completion of basic requirement of phase 1 and phase 2 for safety confirmation and dose determination. Syndrome improvement was chiefly evaluated by Zubrod and karnofsky(%) methods. We suggest the general clinical trial assessment with botanical products, by following assessment points, that is, tumor size for 50 points, survival fate for 10 points, major syndromes for 40 points. It is recommendable that the each symptom of Qi deficiency syndrome, blood deficiency syndrome and Qi stagnation syndrome was allocated by assessment points, Similarly, the each symptom was given the assessment points according to the severity of symptom, for example, slight for 3 points, moderate for 2 points and severe for 1 point in hepatocelluar carcinoma and lung cancer. Then, the efficacy of botanical products was evaluated by the difference between pre-treatment and post-treatment. Asking the neoplastic patients of questionnaire on physical, emotional, cognitive, social and role subjects availability, three more syndromes (Fatigue, Pain and Nausea/Vomit), quality of life(QOL) will be evaluated by GLM statistics. In addition, in case of lung cancer, 13 questions will be asked by the EORTC QLQ-C13 forms. As the assessment of endpoints for efficacy to reduce side effects induced by chemotherapy and radiotherapy, the data of image scanning and hemato-urinalysis can be usefully applied on immune response, weight loss, indigestion, hemopoietic damage and injury of liver and kidney, while the changes of syndromes of side effect can be evaluated by differentiation methods of Qi and blood and five viscera. However, it is still necessary to determine the ratio between scientific analytical method and Oriental differentiation method as well as confirm the Oriental assessment endpoints by clinical trial. In addition, we suggest the continuous development of assessment endpoints on other carcinomas except of hepatocelluar carcinoma and lung cancer in future.

• Journal of Food Hygiene and Safety
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• v.29 no.2
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• pp.152-157
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• 2014

This study was carried out to investigate the residual sulfur dioxide residues ($SO_2$) in commercial medicinal herbs in Korea in 2013. Among a total of 116 samples of 11 different kinds of herbs, 71 samples (11 Kinds) were domestic, and 45 samples (10 Kinds) were imported. The residual contents of $SO_2$ in the samples were determinated by a modified Monier-Williams method. Of the 116 samples, 6 samples (5.2%, 4 Kinds) failed to meet the regulations for sulfur dioxide residues of KFDA in medicinal herbs. Among 6 unsuitable samples, 1 samples (1.4%) were domestic, and 5 samples (11.1%, 3 Kinds) were imported. The highest amount of sulfur dioxide residues was 1546.3 mg/kg (Lycii Fructus) in the domestic samples. Regardless of region, $SO_2$ contents were not found at Anemarrhenae Rhizoma, Citri Unshius Pericarpium, Eucommiae Cortex, Forsythiae Fructus, Gardeniae Fructus, Leonuri Herba and Lonicerae Folium et caulis. These data will be used as a basic data for the future legislation on the regulation and control of sulfur dioxide of herbal medicines.

• The Korean Journal of Blood Transfusion
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• v.23 no.2
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• pp.152-161
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• 2012

Background: Since Jan. 2012, for performance evaluation of viral reagents, analysis of domestic samples has been recommended in order to obtain approval from the KFDA when they are first introduced to Korea. This regulation requires the standard domestic materials driven from locally infected samples. We tried manufacturing the plasma working standards of HBV, HCV, and HIV NAT using a mixed titer of viral loads. Methods: Forty three HBV DNA positive plasmas, 25 HCV RNA positive plasmas, and 26 HIV RNA positive plasmas were evaluated according to viral load and genotype. Several plasma units, which had high-titer viral loads and the common viral genotypes in Korea, were selected as the source materials for each viral standard. To adjust the appropriate concentration based on the detectable range of variable viral reagents, the source plasma was diluted to several concentrations, divided into small vials, and analyzed for quantification. Results: The 13 plasma working standards, which had variable viral loads for the mixed titer performance panel of HIV, HCV, and HBV NAT, were produced. Conclusion: These national standard materials were first produced in order to supply the mixed titer performance panel for the viral NAT reagent of the level IV transfusion related high-risk group in Korea.

• Journal of Physiology & Pathology in Korean Medicine
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• v.33 no.4
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• pp.207-218
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• 2019

It is necessary to investigate the efficacy of commercial Korean herbal medicine for cognitive disorder. The purpose of this study is to select candidates among licensed herbal medicines that are expected to be effective in the treatment of cognitive disorders and can be used in future clinical trial. From laboratory experiments, we first found individual single herbal drugs that could be effective for cognitive disorder, and then through experts recommendation, selected five priorities of single herbal drug and obtained the information of the best herb as a combination of each herbal drug. To derive the final herbal prescriptions, we searched the KFDA drug information system for licensed herbal medicines containing each drug and its combination. As a result of laboratory experiments and experts recommendation, we found that the five effective single herbal drugs for cognitive disorders. They are Ginseng Radix, Acori Graminei Rhizoma, Cyperi Rhizoma, Coptidis Rhizoma, Pinelliae Rhizoma, Hoelen cum Pini Radix, and Rehmanniae Radix Preparata(Pinelliae Rhizoma, Hoelen cum Pini Radix, and Rehmanniae Radix Preparata were tied for $5^{th}$). And licensed herbal prescriptions derived from the planned search are Palbohoichoon-tang, Taehwa-hwan, Bosim-hwan, and so on. Among these, in consideration of the feasibility of research and possibility of success in development, Yukgunja-tang, Samhwangjichul-hwan can be selected as future study subjects. Through experimental studies and expert recommendations, we have derived herbal prescriptions that can be effective in treating cognitive disorders from licensed herbal medicines.

• Asia-pacific Journal of Multimedia Services Convergent with Art, Humanities, and Sociology
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• v.9 no.6
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• pp.701-709
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• 2019

Recently, heart rate signal, which is one of biological signals, have been used in various fields related to healthcare. Conventionally, most of the proposed heart rate signal detection methods are contact type methods, but there is a problem of discomfort that the subject have to contact with the device. In order to solve the problem, detection study by non-contact method has been progressed recently. The detected heart rate signal can be used for finger vein liveness detection and various application using heart rate. In this paper, we propose a method to obtain heart rate signal by using finger vein imaging system. The proposed method detected the signal from the changes of the brightness value in the time domain of the infrared finger vein images and converted it into the frequency domain using the image processing algorithm. After the conversion, we removed the noise not related to the heart rate signal through band-pass filtering. In order to evaluate the accuracy of the signal, we analyzed the correlation with the signal obtained simultaneously with the finger vein acquisition device and contact type PPG sensor approved by KFDA. As a result, it was possible to confirm that the heart rate signal detected in non-contact method through the finger vein image coincides with the waveform of actual heart rate signal.

• The Korea Journal of Herbology
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• v.29 no.3
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• pp.35-42
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• 2014

Objectives : Since single extract powders was released at 1987, the insurance fee has not been changed, but the price of raw material has been increasing. According to this, Pharmaceutical company couldn't invest on quality of the product, so, the quality of single extracts went down and lost the consumer's trust. We checked the contents of marker ingredients in single extract thereby to recover the reliability of insurance-covered herbal preparations. Methods : we bought total twelve products of eight different single extracts of two main pharmaceutical companies among total 65 kinds of single extract powder stipulated in KHP (The Korean Herbal Pharmacopoeia) monograph III at Jan. 2013. Assays of selected single extract powders are performed by KHP regulation. And we surveyed price fluctuation of relevant herb raw materials from 2005 to 2012. Results : Among twelve products, eight single extract powders were suitable by the KHP regulation. But four products didn't reach the content amount of KHP. Marker contents in the single extracts product of Pueraria Root, Licorice, Peony root and Scutellaria Root of A company were 70%, 1%, 23.7% and 75.1%, respectively. Conclusions : We can acertain whether there's a quality problem in the insurance-covered single extract powders. But, A company is no longer producing these improper single extract powders. As a medicine, single extract powders needs to be strictly quality controlled by the company, and regularly monitored by the KFDA.