• Analytical Science and Technology
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• v.25 no.1
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• pp.76-82
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• 2012

The determination and confirmation of dutasteride in human serum was performed by a liquid chromatography-electrospray ionization tandem mass spectrometry (LC-ESI/MS/MS). Beclomethasone as an internal standard (I.S.) was added to the serum and the mixed sample was pretreated by liquid-liquid extraction (LLE) with methyl tert-butyl ether (MTBE). The mass transitions of dutasteride and I.S. monitored in multiple reaction monitoring (MRM) were m/z 529.6${\rightarrow}$461.5 and m/z 409.3${\rightarrow}$391.2, respectively, and the retention times were 6.45 and 5.46 min, respectively. The calibration curve was linear in the concentration range of 0.5~30.0 ng/mL ($R^2$= 0.9999) and the limit of quantitation (LOQ) was found to be 0.5 ng/mL. The recovery of dutasteride was shown to be 66~72%. The intra-day assay precision and accuracy were in the range 3.5~5.5% and 85.7~89.9%, respectively, and the interday assay precision and accuracy were in the range 4.2~5.8% and 90.8~95.8%, respectively.

• Proceedings of the Korean Society of Food Hygiene and Safety Conference
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• 2001.10a
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• pp.140-140
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• 2001

A sensitive analytical method based on gas chromatograpy-mass spectrometry with a selected ion monitoring (GC/MS-SIM) with the purge-and-trap concentration and with headspace method (in limited applications) was developed for determining of epichlorohydrin in canned beverages coated with epoxy resin. The calibration curve in the range of $0.5\sim50ng$ had correlation coefficient greater than 0.998 and a detection limit of $0.l\mug/L$ was obtained using a sample volume of 20ml. The predominant ions of epichlorohydrin produced in MSD using electron ionization(EI) were m/z 57 ([M-CI]+) and 62/64 $([M-CH_2O]+)$. In survey of epichlorohydrin in thirty commercial canned beverage samples, none of them was detected.

• Journal of Pharmaceutical Investigation
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• v.39 no.2
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• pp.111-115
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• 2009

The pharmacokinetics of cyclosporin A (CsA) after single and multiple oral dosing of new CsA self-micro-emulsifying drug delivery system (SMEDDS) in dogs were estimated. A single dose study was performed following a two-way crossover design against six dogs with reference SMEDDS. For a multiple dose study, three dogs were allocated for each drug, and 100 mg of drug was administered daily for 6 days. Whole blood concentration of CsA was analyzed by radio-immunoassay. Both drug showed identical blood concentration profiles in both studies, and no statistical difference was detected in pharmacokinetic parameters. The relative bioavailabilities of test SMEDDS were 91.4% and 89.1%, respectively, in the single dose study and the last day of multiple dose study. Especially, multiple dose study proved the good relationship between C-0/C-2 and AUC for reference SMEDDS, which is an indispensable part of therapeutic drug monitoring. These results suggest newly formulated CsA SMEDDS possibly shows identical pharmacokinetics and pharmacodynamic behaviors in clinical trials.

• Journal of Pharmaceutical Investigation
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• v.38 no.3
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• pp.207-215
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• 2008

Drug approval-patent linkage is the practice of linking drug marketing approval to the patent status of the originator's product and not allowing the grant of marketing approval to any third party prior to the expiration of the patent term unless by consent of the patent owner. Article 18.9.5 of Korea-US Free Trade Agreement requires that Korea introduce the linkage system in drug marketing approval. However, Korea is unfamiliar with the linkage system. In addition, there have been lots of arguments over the impacts of this system on Korean pharmaceutical industry and pharmaceutical market in the future. This report investigated the linkage systems of the US and Canada. The US and Canada have implemented drug approval-patent linkage system since 1984 and 1993, respectively. Both countries have patent lists for drug approvalpatent linkage on which originators are required to list patents on substance, product, and use of their drugs. Generic or follow-on drug applicants must contain a certification regarding each patent listed that relates to the referenced drug. If the patent holder files suit for patent infringement within 45 days of notice of application, drug approval is not allowed for several months - 30 months in the US and 24 months in Canada. Both countries have amended their systems after having experienced unexpected results such as listing improper and additional patents, multiple patent litigations and delayed generic entries. After reviewing the US and Canada's experiences, we suggested three principles needed in implementing the system: protecting patent holder's right; promoting generic drug development and marketing; monitoring the process and the effect of the system.

• Journal of Food Hygiene and Safety
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• v.26 no.4
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• pp.302-307
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• 2011

One of the most important objectives of post-marketing monitoring of dietary supplements is the early detection of unknown and unexpected adverse events (AEs). Several causality algorithms, such as the Naranjo scale, the RUCAM scale, and the M & V scale are available for the estimation of the likelihood of causation between a product and an AE. Based on the existing algorithms, the Korea Food & Drug Administration has developed a new algorithm tool to reflect the characteristics of dietary supplements in the causality analysis. However, additional work will be required to confirm if the newly developed algorithm tool has reasonable sensitivity and not to generate an unacceptable number of false positives signals.

• The Journal of Korean Academic Society of Nursing Education
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• v.16 no.2
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• pp.330-338
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• 2010

Purpose: This study was conducted to investigate performance of self-monitoring of blood glucose and the utilization of results for people with type II diabetes. Method: Data was collected from 177 patients with type II diabetes using a questionnaire from August to September, 2009. Result: Most participants performed self-monitoring of blood glucose in the correct way while some misused the lancet or test strips. In the utilization of results for self-monitoring blood glucose data, 62% of participants always recorded the data, 46% always understood the cause for hyperglycemia or hypoglycemia, 25% changed their diet, 23% regulated their exercise-amount, and 11% of participants adjusted the drug dosage. There were significant differences in the performance of self-monitoring of blood glucose and the utilization of results according to the characteristics in the self-monitoring subjects such as awareness of HbA1c, target fasting glucose level, target fasting glucose level 2 hours after meal etc. Conclusion: Systemic self-monitoring of blood glucose education which includes the utilization of self-monitoring of blood glucose needs to be developed for type II diabetic patients.

• Analytical Science and Technology
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• v.24 no.5
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• pp.345-351
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• 2011

A liquid chromatography-electrospray ionization tandem mass spectrometry (LC-ESI/MS/MS) method was developed and validated for the determination of finasteride in human serum. Beclomethasone was used as internal standard (IS) and liquid-liquid extraction (LLE) using methyl tert-butyl ether (MTBE) was carried out to isolate analyte. The mass transitions monitored in multiple reaction monitoring (MRM) in positive ion mode were m/z 373.2${\rightarrow}$305.2 for finasteride and m/z 409.3${\rightarrow}$391.2 for IS. Retention times of finasteride and IS were 5.81 and 5.46 min, respectively. The limit of quantitation (LOQ) was 0.1 ng/mL and the calibration curve showed good linearity in the range of 0.1~20.0 ng/mL ($R^2$=0.9997). The intra-day assay precision and accuracy were in the range 6.3~10.6% and 97.3~103.6%, respectively, and the inter-day assay precision and accuracy were in the range 0.8~5.2% and 99.8~102.5%, respectively. The sample extract recovery of the method was 80~83%.

• Journal of Food Hygiene and Safety
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• v.25 no.2
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• pp.185-191
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• 2010

In this study, monitoring of food additives as an artificial sweetener on favorite foods of children, which are deal at retail store and stationery store around eliminatory school, was performed. We analyzed aspartame, potassium acesulfame, sodium saccharin, and cyclamate from candys, biscuits, chocolates and others. Total 604 items as targeted food were collected from the other country; 285 items of candys, 131 items of biscuits, 74 items of chocolates., 114 items of others. Targeted foods were classified by manufacture nation; 308 samples from domestic products, 211 from China, 26 from Indonesia, and 59 items from other nations. Artificial sweeteners were detected from 75 cases of food stuff which were 38 native product, 25 China, 9 Indonesia, and 3 others. The percentage of detected artificial sweeteners was aspartame 7.8% (47 cases), potassium acesulfame 3.0% (18 cases), sodium saccharin 1.8% (11 cases), and cyclamate 2.6% (16 cases). The detected concentration were followed [average(minimum-maximum) mg/kg]; aspartame 817 (21-4,988), potassium acesulfame 192 (24-1,136), sodium saccharin 91 (5-326), and cyclamate 926 (8-4,680). Aspartame was detected mainly on Korea foods, and cyclamate and sodium saccharin were detected from Indonesia food, artificial sweeteners were detected Chinese food, broadly. As a result, 17 cases were violated against regulatory standard of cyclamate, and sodium saccharin. Considering average body weight (36.9 kg) and daily intake of biscuits (15.6 g) for elementary student, ratio of estimated daily intake and acceptable daily intake was 0.86% for aspartame, 0.54% for potassium acesulfame, 0.77% for sodium saccharin, and 3.56% for cyclamate.

• Korean Journal of Food Science and Technology
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• v.39 no.3
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• pp.237-245
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• 2007

We tested for residual pesticide levels in agricultural products purchased from 5 provinces within the middle region of Korea during 2006. A Total of 488 samples of 23 different types of agricultural products were analyzed by GC/MS, GC-NPD, and LC/MS/MS. We used multi-analysis methods to analyze for 231 different pesticide types; a single residual pesticides were detected in 92 samples (18.9%), of which 9 samples (1.9%) exceeded the Korea Maximum Residue Limits (MRLs). we detected pesticide residue in more than 50% of the pepper leaf and welsh onion samples. For the welsh onions, 16 among the 30 analyzed samples contained pesticide residue, and 4 samples exceeded the Korea MRLs. Among the 234 kinds of pesticides we tested for, 42 were detected, and 21 of them were detected more than twice. Six pesticide residue types, including cypermethrin, iprodione, fludioxonil, ethoprophos, flutolanil, and lufenuron, exceeded the MRLs. No residual pesticides were detected in 396 of the samples (81.1%), and the residual pesticide levels in 83 samples (17.0%) were lower than the Korea MRLs, indicating that 98.1% of the samples were relatively safe.

• Journal of Food Hygiene and Safety
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• v.25 no.1
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• pp.73-78
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• 2010

This research was conducted to assess applicability of photostimulated luminescence (PSL) and Thermoluminescence (TL) methods for investigation of infant and young children products, nut, seasoned dried fish, spice, dried fruits, fruit & vegetable, grain and marine products, which are not approved for irradiation in Korea. PSL results show that the photon counts of non-irradiated samples were lower than 700, while those of irradiated samples were higher than 700. In TL measurement, TL ratio of irradiated samples were higher than 0.1 or ones can decrease below 0.1 whereas the temperature range of TL Glow curve was between $150{\sim}250^{\circ}C$. Monitoring result about 8 class of 325 not approved to irradiated foods, photon counts of samples were less than 700, and after re-irradiation TL Ratio ($TL_1/TL_2$) through re-irradiation step at 1 kGy were higher than 0.1 for the all samples. Therefore, these results suggested that PSL and TL measurements were useful detection methods for 8 class food products not approved to irradiation in Korea and all sample (325 cases) were not irradiated when we analysed by PSL and TL methods.