• 약학회지
• /
• 제57권3호
• /
• pp.173-186
• /
• 2013

To ensure the safe use of pharmaceuticals in the market, US, EU and Japan reached a consensus to adopt ICH harmonised tripartite guideline "E2E Pharmacovigilance Planning" in 2004. Subsequently these regions established and implemented new pharmaceutical safety management systems for patients based on ICH E2E guideline and Risk Evaluation and Mitigation Strategy (REMS) in US or Risk Management Plan (RMP) in EU and Japan. In this study we investigated these new foreign systems and suggested a way to improve Korea's regulatory system for pharmaceutical safety management under Korea Pharmaceutical Law in the view of international harmonization.

• 한국어병학회지
• /
• 제27권1호
• /
• pp.67-75
• /
• 2014

Aquaculture drugs have used to prevent disease in aquaculture field for many years. In spite of many advantages, overdose and abuse may cause environmental pollutions and antibiotic resistances. Many countries try to protect the environment, biospecies and food safety. Recently, Korea enact laws and ordinances such as the Aquatic Animal Disease Control Act. The purpose of this act to contribute to the stable production and control system for aquatic diseases. The Maximum residue limits (MRLs) of aquaculture drugs have been established by Ministry of Food and Drug Safety (MFDS) and Drug licensing was in National Fisheries Research and Development Institute (NFRDI) by Aquatic Animal Disease Control Act. There is 750 items in aquaculture drugs and these are classified into 4 group, which is approval, necessary for prescription, unregulated and safety drug, and banned drug. MRLs of 30 items in aquaculture drug have been established by Food Sanitation Act. Future research is required to determine the suitable for abundant varied fishes of drugs for side effects and safety.

• Composites Research
• /
• 제24권3호
• /
• pp.17-24
• /
• 2011

Ag/Cu층에서 발생하는 misfit 전위를 분석하기 위하여, EAM기법을 활용한 나노인덴테이션 해석을 수행하였다. N$\'{o}$se-Hoover 서모스텟 조건에 의거하여, 2-5nm 정도의 두께를 갖는 필름층에 구형 인덴터로 압입하였다. 해석결과는 misfit 전위에 대한 상대적인 압입위치가, 4nm이하의 필름에 대하여 영향을 미치는 것으로 나타났다. 전위에 의한 슬립 발생할 때 탄성에너지 변화는 Ag/Cu의 연화의 중요한 변수로 작용하며, 각각의 경우에 대하여 임계필름두께에 대해서도 고찰하였다.

• 약학회지
• /
• 제60권2호
• /
• pp.73-77
• /
• 2016

Alginic acid and carboxymethyl cellulose sodium are dietary fibers from plants. They have a swelling property and delay the gastric emptying time, thereby resulting in feeling satiated after oral administration, which may eventually contribute to loss of body weight. The goal of this study was to compare swelling property of three commercial matrix tablets based on alginic acid and carboxymethyl cellulose sodium. When the swelling was determined by the Korean Ministry of Food and Drug Safety (MFDS) guideline, the tablet prepared by direct compression method with highly viscous swelling agent showed the highest swelling in acidic conditions. Water uptake of these tablets was rapid and completed within 30 min. Moreover, when the pH was changed from 2.5 to 6.8 buffer, the water uptake was not significantly changed in all tablets.

• 대한치과마취과학회지
• /
• 제13권4호
• /
• pp.167-178
• /
• 2013

Oxycodone is a semi-synthetic opioid synthesized from poppy-derived thebaine. It is a narcotic analgesic generally indicated for relief of moderate to severe pain. Although developed in an attempt to improve on the existing opioids, the adverse effects of oxycodone are those that are typically found in opioids. In recent years, the use of the opioid oxycodone has increased markedly and replacing morphine as the first line choice of opioid in several countries. There are formulations for oral immediate, oral extended release and intravenous use. In 2013, intravenous oxycodone was approved for marketing by Ministry of Food and Drug Safety (MFDS), with the indication of postoperative intravenous patient-controlled analgesia (IV PAC). Simulation study of oxycodone demonstrated that minimum effective analgesic concentration (MEAC) of oxycodone was most quickly reached with higher loading dose and IV PCA with background infusion, which may reduce the necessity of rescue analgesics during immediate postoperative period. Previous studies for postoperative pain management with intravenous oxycodone are limited in sample size, mostly less than 100 patients, which may not be large enough to assess safety of intravenous oxycodone. The effectiveness and tolerability of IV PCA with oxycodone should, therefore, be evaluated in large scale clinical trials in Korean populations.

• 한국임상약학회지
• /
• 제29권3호
• /
• pp.202-208
• /
• 2019

Objective: Suicide has recently become an important social problem. Thus, we analyzed prescription drugs that cause suicidal ideation. Methods: Of 156 drugs on the the Minister of Food and Drug Safty (MFDS) EZ-Drug site that had "suicide" listed as a side effect, 78 had "suicide" listed as a warning or contraindication; those 78 drugs were analyzed using data from the 2016 Health Insurance and Review and Assessment Services National Patient Sample (HIRA-NPS). Results: 51 "suicide risk" drugs was identified. Of all patients, 5.2% had received such drugs. The prescription rate was 0.8% of all prescriptions, accounting for 1.6% of all prescription days. From logistic regression analysis, the prescription rate for the drugs was approximately 1.1 times higher for women than for men. With regard to age, the prescription rate for patients 66 years and older was 15.5 times higher than those for patients 25-years and lower. With regard to medical departments, the prescription rates in psychiatry and dermatology departments were 8.1 times higher and 0.6 times lower than those in internal medicine departments, respectively. With regard to region, the prescription rates in Daegu and Jeju were 1.3 times higher and 0.79 times lower than those in Seoul, respectively. Conclusion: Drug-induced suicidal behavior is possible, and therefore efforts are needed to prevent it.

• Mass Spectrometry Letters
• /
• 제12권1호
• /
• pp.11-15
• /
• 2021

Nitarsone is an organoarsenic antiprotozoal drug widely used to treat blackhead disease in turkeys and chickens. However, since its biological conversion into inorganic arsenic, a carcinogen was known, its residue in foods should be regulated. Thus, here, a novel method to determine residual nitarsone in various food commodities (pork, milk, egg, halibut, eel, and shrimp) using QuEChERS and LC-MRM was developed. The developed method was successfully validated through specificity, linearity (coefficient of determination, at least 0.991), recovery (R, 63.6 - 85.6%), precision (the relative standard deviation of R, 0.5 - 10.6%), and sensitivity (the lower limit of quantitation, 5 ppb) by following the Ministry of food and drug safety (MFDS) guidelines. The present method is the first mean to quantitate nitarsone using LC-MRM, and it was designed to be conveniently merged into a new method to quantitate multiple veterinary drugs for the positive list system (PLS). Therefore, the present method could contribute to fortify the food safety system in South Korea.

• 한국미생물·생명공학회지
• /
• 제50권4호
• /
• pp.465-476
• /
• 2022

The importance of beneficial microorganisms, particularly probiotics, that coexist in the human body, is being increasingly recognized. Probiotics are representative health functional foods that provide health benefits to humans through the production of various metabolites, including short-chain fatty acids. However, the health benefits are strain-specific, and the use of each probiotic strain should follow guidelines that assure its safety. Accurate identification of the strain should be managed through genetic and phenotypic analyses of the strain. Besides, the functionality of probiotics should be disclosed in vitro and in vivo so that they can be used as legal functional ingredients (i.e., individual standards). In this review, we deal with the guidelines, including the technical factors related to probiotic strains. The common health effects of probiotic strains include proliferation of beneficial bacteria, control of harmful bacteria, and facilitation of bowel activities. Probiotics with various functionalities (e.g., body fat and cholesterol reduction, vaginal health, and improvement of skin's immune system) have been investigated as "individual standards of raw materials for health functional foods" provided by MFDS. In the future, various biotechnologies including synthetic biology can be applied to produce customized probiotics to improve human health.

• 대한의용생체공학회:의공학회지
• /
• 제44권2호
• /
• pp.99-108
• /
• 2023

According to the COVID-19, development of various medical software based on IoT(Internet of Things) was accelerated. Especially, interest in a central software system that can remotely monitor and control ventilators is increasing to solve problems related to the continuous increase in severe COVID-19 patients. Since medical device software is closely related to human life, this study aims to develop central monitoring system that can remotely monitor and control multiple ventilators in compliance with medical device software development standards and to verify performance of system. In addition, to ensure the safety and reliability of this central monitoring system, this study also specifies risk management requirements that can identify hazardous situations and evaluate potential hazards and confirms the implementation of cybersecurity to protect against potential cyber threats, which can have serious consequences for patient safety. As a result, we obtained medical device software manufacturing certificates from MFDS(Ministry of Food and Drug Safety) through technical documents about performance verification, risk management and cybersecurity application.

• Natural Product Sciences
• /
• 제21권1호
• /
• pp.34-41
• /
• 2015

The objective of this study is to characterize a toxicity of Epimedii Herba (EH) in F344 rats and to find a dose levels for the 13 weeks toxicity study. EH is well known as medicinal herb in many Asian countries for traditional medicines of antibacterial and antiviral effects, estrogenic and antiestrogenic effects, and for treatment of osteoporosis, hypotensives, fatigue, kidney disorders, and related complications. However, the indispensable and basic information of toxicological evaluation of EH extract is insufficient to support its safe use. Therefore, we conducted toxicological evaluation of this drug in compliance with OECD and MFDS guideline in this study. The extract of EH was administered orally to F344 rats at dose levels of 0, 500, 1000, 2000, 3500, and 5000 mg/kg/day for 2 weeks. Each group was composed of 5 male and female rats. In this study, there were no treatment of EH-related adverse changes in clinical observations, mortality, body weights, food consumption, urinalysis, gross finding at necropsy, and organ weight examination. Total red blood cell count, hematocrit, mean corpuscular hemoglobin concentration, total cholesterol, and phospholipid were decreased in males and females at 5000 mg/kg/day compared to the control animals. Mean corpuscular volume and reticulocyte counts were increased in males and females at 5000 mg/kg/day compared to control animals. Therefore, we recommend that dose level of 5000 mg/kg/day is a highest treatment group in 13-week EH extract exposure study for further toxicity assessment.