• Title/Summary/Keyword: Medical products

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Guideline for Bioequivalence Studies of Generic Products for Topical Use (국소용 후발의약품의 생물학적동등성시험을 위한 가이드라인)

  • Choi, Sun-Ok;Jung, Sung-Hee;Um, So-Young;Jung, Seo-Jeong;Kim, Joo-Il;Chung, Soo-Youn
    • Journal of Pharmaceutical Investigation
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    • v.34 no.4
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    • pp.333-340
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    • 2004
  • A new medical system of separation of dispensary from medical practice was started in 2000 in Korea. To expand bioequivalence-proven drug products and to ensure the credibility of the therapeutic equivalence of generic drug are hot issues in Korea. The KFDA also has a plan to revise the pharmaceutical affairs law that bioequivalence reports of all the generic prescription drugs should be submitted to the KFDA in the application for drug approval. Therefore, it becomes more necessary to develop bioequivalence-demonstrating methods for specific preparations such as topical drug products. There are some differences between US and Japanese guidances of bioequivalence studies of generic drug products for topical use. In this paper, we examined the recently published Japanese guideline, Guideline for Bioequivalence Studies of Generic Products For Topical Uses, and Q&A of the guideline, which will be references to make a guidance on bioequivalence studies of topical drug products in Korea.

A Study on the trends of Meebyung research ('미병(未病)' 연구의 경향에 관한 고찰)

  • Lee, Sang-Jae;Li, Song-Shi;Kim, Do-Hoon
    • Journal of Korean Medical classics
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    • v.23 no.5
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    • pp.23-34
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    • 2010
  • Contemporary topic of the culture is turning to the Nature. In this situation, The Paradigms of realization about Human body and medical science are changing. The new interpretation of the value of Health is another method of recovering the Nature. Oriental medicine has mainly dealt with health preserving idealogy in origin, and pursued it. Get out of the curing medicine, the health preserving idealogy which aims to live up to one's lifespan has been becoming the main idea of Oriental medicine. In this respect, we can extract insperation from the concept of Meebyung and preventive treatments which came from the ideas of preventive medicine in Oriental medicine. Among the researches of Meebyung in Oriental medical classics and in Oriental tri-countries, we grasped and analyzed the trends of them. In connection with the most fundamental project in Meebyung study which is to set up the concept of Meebyung, we inspected the standards which can categorize and diagnose Meebyung. In contrast with 'Ibyeong', Meebyung in Oriental medical classics can be attained from living in harmony with the Nature, four seasons, Eum-and-Yang and the Five Phases. However the classification of Meebyung, Yogbyeong, Ibyeong in medical classics made foundation of post preventive medicine. From the various studies we can find as follws. Promting national project in Meebyung, China is trying to reestablish classifications of Meebyung, as Japanese Meebyung scholars are focusing on quantitative methods. Although there are not enough research products, Korea must absorb the products of such other countries, as to categorize Meebyung through the pattern identification system of Oriental medicine, and achieve our goal of promotion of health.

Activation of MAPK Is Required for ROS Generation and Exocytosis in HMC-1 Cells Induced by Trichomonas vaginalis-Derived Secretory Products

  • Narantsogt, Giimaa;Min, Arim;Nam, Young Hee;Lee, Young Ah;Kim, Kyeong Ah;Agvaandaram, Gurbadam;Dorjsuren, Temuulen;El-Benna, Jamel;Shin, Myeong Heon
    • Parasites, Hosts and Diseases
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    • v.53 no.5
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    • pp.597-603
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    • 2015
  • Trichomonas vaginalis is a flagellated protozoan parasite that causes vaginitis and cervicitis in women and asymptomatic urethritis and prostatitis in men. Mast cells have been reported to be predominant in vaginal smears and vaginal walls of patients infected with T. vaginalis. Mitogen-activated protein kinase (MAPK), activated by various stimuli, have been shown to regulate the transcriptional activity of various cytokine genes in mast cells. In this study, we investigated whether MAPK is involved in ROS generation and exocytotic degranulation in HMC-1 cells induced by T. vaginalis-derived secretory products (TvSP). We found that TvSP induces the activation of MAPK and NADPH oxidase in HMC-1 cells. Stimulation with TvSP induced phosphorylation of MAPK and $p47^{phox}$ in HMC-1 cells. Stimulation with TvSP also induced up-regulation of CD63, a marker for exocytosis, along the surfaces of human mast cells. Pretreatment with MAPK inhibitors strongly inhibited TvSP-induced ROS generation and exocytotic degranulation. Finally, our results suggest that TvSP induces intracellular ROS generation and exocytotic degranulation in HMC-1 via MAPK signaling.

Trends of Market and Approval Management System for in vitro Diagnostic Veterinary Medical Reagents in Korea

  • Kang, Kyoung-Mook;Kang, Min-Hee;Suh, Tae-Young;Kang, Hwan-Goo;Moon, Jin-San
    • Journal of Veterinary Clinics
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    • v.35 no.4
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    • pp.119-125
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    • 2018
  • In vitro diagnostic veterinary medical reagents (IVDVMRs) were diverted the medical devices from medicine by the revision of the pharmaceutical affairs act enforcement regulations in 2015 in Korea. It classified into class I-IV according to risks of individual and public health. However, good manufacturing practices requirements on IVDVMRs were exempted from the current system. The registration of IVDVMRs by the Animal and Plant Quarantine Agency has gradually increased since 2012, and total of 584 products from 68 companies were registered from 1978 to 2017. Most of these items are clinical immunochemistry (infection disease), clinical immunochemistry (non-infection disease), molecular genetics, endocrinology, blood gas analysis, clinical microbiology, toxin, heavy metal and drug of abuse, other etc. The market size of IVDVMRs reported from the Korea Animal Health Products Association was estimated to be approximately 51.9 billion won in 2017. The domestic consumption and the export sales were approximately 31.2 and 20.7 billion won, respectively. They are increasing 23.9% (CAGR) in domestic consumption and 40.4% (CAGR) in export from 2011 to 2017.

Explainable Machine Learning Based a Packed Red Blood Cell Transfusion Prediction and Evaluation for Major Internal Medical Condition

  • Lee, Seongbin;Lee, Seunghee;Chang, Duhyeuk;Song, Mi-Hwa;Kim, Jong-Yeup;Lee, Suehyun
    • Journal of Information Processing Systems
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    • v.18 no.3
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    • pp.302-310
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    • 2022
  • Efficient use of limited blood products is becoming very important in terms of socioeconomic status and patient recovery. To predict the appropriateness of patient-specific transfusions for the intensive care unit (ICU) patients who require real-time monitoring, we evaluated a model to predict the possibility of transfusion dynamically by using the Medical Information Mart for Intensive Care III (MIMIC-III), an ICU admission record at Harvard Medical School. In this study, we developed an explainable machine learning to predict the possibility of red blood cell transfusion for major medical diseases in the ICU. Target disease groups that received packed red blood cell transfusions at high frequency were selected and 16,222 patients were finally extracted. The prediction model achieved an area under the ROC curve of 0.9070 and an F1-score of 0.8166 (LightGBM). To explain the performance of the machine learning model, feature importance analysis and a partial dependence plot were used. The results of our study can be used as basic data for recommendations related to the adequacy of blood transfusions and are expected to ultimately contribute to the recovery of patients and prevention of excessive consumption of blood products.