• Korean Journal of Clinical Pharmacy
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• v.28 no.2
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• pp.88-94
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• 2018

Background: We strived to evaluate the status of nivolumab use and associated factors on the clinical efficacy of the drug. Methods: The study was retrospectively conducted in patients who had been administered nivolumab at least once at the cancer center of Seoul National University Hospital from June 2015 to April 2017. Data were collected from electronic medical records. A medication-use evaluation was performed based on the American Society of Health-System Pharmacists mediation-use guidelines. Results: Sixty-six of the 74 patients (89.2%) showed indications approved for nivolumab use by the Korean Ministry of Food and Drug Safety (MFDS; n=55) or the US Food and Drug Administration (FDA; n=11). Approximately 73.0% of the patients were administered the approved dose of 3 mg/kg but 25.7% were administered an unapproved fixed dose of 100 mg. The overall response rate was 21.7%, and the response rate of non-small cell lung cancer patients, who accounted for the largest number of indications, was 18.8%. Adverse reactions were found in 90.1% of the patients and were mostly mild (86%). The expression of programmed death-ligand 1 (PD-L1) was analyzed as a factor affecting treatment response (p=0.028, odds ratio [OR]=11.331). Conclusion: PD-L1 expression was found to affect treatment response. However, caution is required while using an unapproved dosage and in the absence of monitoring for effectiveness and safety. Therefore, an effective protocol or instruction manual for the proper use of nivolumab should be considered.

• Korean Journal of Clinical Pharmacy
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• v.9 no.1
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• pp.35-43
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• 1999

Over the last 50 years, a number of antibiotic agents have been developed and clinically used in the area of infectious diseases. Due to antimicrobial resistance problems and increasing health care costs, the rational use of antibiotics has been required. As a drug of choice to treat infections caused by MRSA, vancomycin has been extensively prescribed since the late 1970's. Recently, reports of vancomycin-resistant organisms such as VRE and VRSA have been increased to draw medical concerns. The objectives of this study were to evaluate the rational use of vancomycin and the appropriateness of the Restrictional Program of Antibiotic Utilization (RPAU) which has been operated at Samsung Medical Center. A retrospective chart review was performed in 132 hospitalized patients treated with vancomycin in the surgery departments from. January to June 1998. The guidelines of ASHP and HICPAC for vancomycin were modified and used as our criteria to determine the vancomycin DUE. In one hundred out of the patients, uses of vancomycin were approved by the Department of Infectious Diseases (DID) based on the RPAU. Vancomycin was appropriately used in $62.5\%$ of the 100 patients according to the criteria of justification of use, while $60.0\%,\;60.0\%,\;79.0\%,\;and\;51.0\%$ of the patients showed appropriate according to those of lab reports such as applicable culture obtained, pretreatment SCr, WBC and serum drug concentration monitoring, respectively. Although the rest 32 patients were not approved to receive vancomycin by the DID, twenty two percent continued receiving vancomycin treatment. This might result from the fact that the RPAU was started not before the use of antibiotics but in the middle of antimicrobial therapy. Continual education should be provide to the related health professionals and the RPAU should be simultaneously modified in order to increase the rate of appropriate uses of antibiotics.

• Korean Journal of Clinical Pharmacy
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• v.8 no.1
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• pp.35-46
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• 1998

A retrospective study was conducted to evaluate the appropriateness of total parenteral nutrition (TPN) for 200 hospitalized adult patients in Samsung Medical Center from January 1st in 1995 to June 31st in 1997. Standard criteria were modified and determined from those stated by AJHP (American Journal of Health System Pharmacy) and ASPEN (American Society of Parenteral and Enteral Nutrition). The justification for indications was appropriate in $35\%,\;44\%,\;and\;32\%$ of the patient's in 1995, 1996, and 1997, respectively, without significant improvement over the last two and half years. Before and during the administration of TPN, several monitoring indicators were well documented, and monitoring frequencies were increased over two and half years period. However, the majority of the monitoring indicators were not found in the standard criteria range of $90\%$. The monitoring indicators for electrolyte balance, $PO_4$ and Mg, were not measured appropriately and resulted in the complications which could have been prevented. The indicator for lipid tolerance, triglyceride and the indicator for hemorrhagic incidence, prothrombin time (PT), were not well documented in comparison with other indicators. The indicators for the improvement in nutritional status, albumin and total protein, were appropriate in $90\%$ of the patients. Determination of TPN formula was based on the laboratory data and chart reviews, and it was appropriate in $98\%$. But the administration of lipid and vitamin K for the prevention of essential fatty acid deficiency and hemorrhage, respectively, was not carried out appropriately when the administration of TPN was prolonged, lasting more than 7 days. When a patient returned to oral or enteral feeding, TPN was terminated. However, increase in albumin level or weight was rarely observed. In conclusion, healthcare professionals should all work as a team and active participation to provide optimized nutrition support for partners.

• Journal of Food Hygiene and Safety
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• v.32 no.4
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• pp.290-297
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• 2017

The purpose of this study was developed for the determination of tridemorph in agricultural commodities samples. Tridemorph residues in samples were extracted with acetonitrile, partitioned with saline water, and then purified using and aminopropyl ($NH_2$) SPE catridge. The purified samples were quantified and confirmed via liquid chromatograph-tandem mass spectrometer (LC-MS/MS) in positive ion mode using multiple reaction monitoring (MRM). Matrix-matched calibration curves were linear over the calibration ranges (0.005~2.5 ng) into a blank extract with $r^2$ > 0.999. The limits of detection and quantification were 0.001 and 0.005 mg/kg, respectively. The average recovery ranged between 75.9% and 103.7% at different concentration levels (LOQ, 10 LOQ, 50 LOQ, n = 5) with relative standard deviations (RSDs) less than 9.0%. An interlaboratory study was conducted to validate the method by Korea Advanced Food Research Institute. The average recovery ranged between 87.0% and 109.2% at different concentration levels (LOQ, $10{\times}LOQ$, $50{\times}LOQ$, n = 5) with relative standard deviations (RSDs) less than 8.0%. All values were consistent with the criteria ranges requested in the Codex guidelines (CAC/GL40, 2003) and Food Safety Evaluation Department guidelines (2016). The results prove that the developed analytical methods is accurate, effective and sensitive for tridemorph determination.

• Journal of Food Hygiene and Safety
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• v.39 no.2
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• pp.72-82
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• 2024

This study aimed to develop a scientifically and systematically standardized xylooligosaccharide analytical method that can be applied to products with various formulations. The analysis method was conducted using HPLC with Cadenza C₁₈ column, involving pre-column derivatization with 1-phenyl-3-methyl-5-pyrazoline (PMP) and UV detection at 254 nm. The xylooligosaccharide content was analyzed by converting xylooligosaccharide into xylose through acid hydrolysis. The pre-treated methods were compared and evaluated by varying sonication time, acid hydrolysis time, and concentration. Optimal equipment conditions were achieved with a mobile phase consisting of 20 mM potassium phosphate buffer (pH 6)-acetonitrile (78:22, v/v) through isocratic elution at a flow rate of 0.5 mL/min (254 nm). Furthermore, we validated the advanced standardized analysis method to support the suitability of the proposed analytical procedure such as specificity, linearity, detection limits (LOD), quantitative limits (LOQ), accuracy, and precision. The standardized analysis method is now in use for monitoring relevant health-functional food products available in the market. Our results have demonstrated that the standardized analysis method is expected to enhance the reliability of quality control for healthy functional foods containing xylooligosaccharide.

• Korean Journal of Food Science and Technology
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• v.43 no.2
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• pp.230-234
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• 2011

According to the Codex committee, the maximum allowable level for lead in fruits is 0.1 mg/kg. This survey was conducted as a surveillance program following the establishment of safety guideline for fruits in Korea. Concentrations of lead (Pb), cadmium (Cd), arsenic (As) and mercury (Hg) were measured in 927 samples using a ICP-MS and a mercury analyzer. The recoveries of microwave digestion method were 86.0-110.4% for Pb, 81.0-104.0% for Cd and 82.0-104.7% for As by standard addition method. The recovery of direct mercury analyzer was 106.5% for Hg. The average levels of Pb in ${\mu}g/kg$ were $10.0{\pm}12.8$ for apple, $8.8{\pm}10.9$ for pear, $4.1{\pm}4.4$ for persimmons, $14.9{\pm}12.3$ for mandarin, $7.1{\pm}6.5$ for orange, $3.1{\pm}3.3$ for banana, $8.8{\pm}8.9$ for kiwi, and $9.3{\pm}9.7$ for mango. The average levels of Cd in ${\mu}g/kg$ were $0.4{\pm}0.3$ for apple, $2.0{\pm}1.6$ for pear, $0.3{\pm}0.3$ for persimmon, $0.1{\pm}0.1$ for mandarin, $0.1{\pm}0.1$ for orange, $1.3{\pm}1.8$ for banana, $0.5{\pm}0.5$ for kiwi, and $0.7{\pm}0.6$ for mango. The average levels of As in ${\mu}g/kg$ were $2.0{\pm}2.1$ for apple, $1.2{\pm}1.3$ for pear, $1.5{\pm}1.2$ for persimmon, $0.8{\pm}0.3$ for mandarin, $1.5{\pm}0.5$ for orange, $1.8{\pm}1.2$ for banana, $1.6{\pm}1.5$ for kiwi, and $1.2{\pm}1.5$ for mango. The average levels of Hg in ${\mu}g/kg$ were $0.5{\pm}0.4$ for apple, $0.3{\pm}0.2$ for pear, $0.2{\pm}0.1$ for persimmon, $0.2{\pm}0.1$ for mandarin, $0.2{\pm}0.1$ for orange, $0.2{\pm}0.0$ for banana, $0.2{\pm}0.2$ for kiwi, and $0.6{\pm}0.2$ for mango. Based on the Korean public nutrition report 2005, these levels (or amounts) are calculated only at 0.17% for Pb, 0.013% for Cd and 0.006% for Hg of those presented in provisional tolerable weekly Intake (PTWI) which has been established by FAO/WHO. Therefore, the levels presented here are presumed to be adequately safe.

• Journal of Food Hygiene and Safety
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• v.35 no.3
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• pp.234-242
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• 2020

In this study, we monitored the raw materials in home-meal replacement (HMR) products, which have shown more than 63% growth in market size for two years. A total of 89 HMR products were purchased and the DNA barcodes of 112 raw materials in the product samples were analyzed. In order to identify the raw material species, a primer set specific for the 16S ribosomal RNA region of each raw material species was amplified. The amplicon was purified and sequenced, and then used to perform a BLAST search provided by the National Institutes of Health (NIH). The species of the raw material was determined by comparing the nucleotide sequences of the species registered in GenBank with identity and match score. Twenty-four species and three genera were identified from 112 raw materials. Three genera were identified at the genus level because a large number of species belonging to the same genus exist within 98% of the identity criteria. The results of the determination were compared with the available raw materials suggested in the Korea Food Code to determine the Korean name and availability of the foods. Six non-listed species were determined to be edible according to information provided by influential domestic and foreign organizations.

• Korean Journal of Food Science and Technology
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• v.42 no.4
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• pp.508-513
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• 2010

Ninety three strains (4.2%) of Vibrio parahaemolyticus were isolated from 2,239 samples of commercial marine products during 2006-2008 in Seoul, Korea. We examined 16 antimicrobial susceptibilities of 93 V. parahaemolyticus isolates. Antibiotic resistance of V. parahaemolyticus was most frequently observed to ampicillin (93.5%), followed by cephalothin (90.3%), streptomycin (87.1%), ticarcillin (55.9%), and amikacin (40.9%). Antibiotic susceptibility was most frequently observed to nalidixic acid, chloramphenicol and ampicillin/sulbactam (100%), followed by trimethoprim/sulfamethoxazole (98.9%), gentamicin and tetracycline (82.8%), and ceftriaxone (63.4%). In addition, the isolates also displayed intermediate resistance to kanamycin (79.6%), ciprofloxacin (64.5%), amikacin (47.3%) and cefoxitin (43.0%). All isolates were resistant to more than two drugs. The most prominent multiple drug resistance was 3 drug resistance (37.6%), followed by 4 drug (24.7%), 5 drug (17.2%), and 6 drug resistance (11.8%). The most prominent multiple drug resistance pattern was the cephalothin-streptomycin-ampicillin resistance pattern (22.6%), followed by cephalothinticarcillin-streptomycin-ampicillin (18.3%) and cephalothin-ticarcillin-streptomycin-ampicillin-amikacin (9.7%). Multiple drug resistance patterns of V. parahaemolyticus from marine products require continuous monitoring.

• Journal of Food Hygiene and Safety
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• v.25 no.3
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• pp.226-231
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• 2010

We aimed at the monitoring medroxyprogesterone acetate (MPA) residue amount in meats and confirmed the safety of its residue in meats. Optimized condition for analytical and instrumental methods was obtained by method validation. The limit of detection (LOD) and limit of quantification (LOQ) were validated at 1.5 and 5.0 ug/kg, respectively. The calibration curve showed good linearity ($r^2$ = 0.9968) within the concentration range of 5.0~50.0 ug/kg. We selected progesterone-d9 for internal standard, The recoveries in fortified meat ranged from 67.5 to 109.56% at the 3 spiking levels. As the regulation of MPA analysis method used by LC-MS/MS on other products have established. We selected 3 species of farm stock products (cattle, pig, chicken) and purchased at the markets of seven major cities. The total 196 of meat including 46 of domestic beef, 43 of import beef, 60 of domestic pork, 12 of import pork and 35 of domestic chicken. No residue of synthetic growth hormones were detected in cattle, pig and chicken samples tested.

• 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 $Tablet^{(R)}$.