• Title/Summary/Keyword: Drug Uses

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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.

The Metformin Use and Gastric Cancer Risk (메트포르민의 사용과 위암 발생)

  • Kim, Young-Il
    • Journal of Digestive Cancer Reports
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    • v.8 no.2
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    • pp.97-101
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    • 2020
  • Metformin is a widely used first-line anti-diabetic drug worldwide. Epidemiologic studies using the large population-based cohort database have shown the association between metformin uses and reduced risk of various type cancers including gastric cancer. In the gastric cancer prevention, metformin use was associated with the significant reduction of gastric cancer risk, especially for long-term metformin users. However, there is no well-designed randomized controlled clinical trial investigating the effect of metformin as a chemopreventive drug for gastric cancer. Therefore, further well-designed clinical trials will be needed to implement metformin for chemoprevention of gastric cancer.

Discrimination of biological and artificial nicotine in e-liquid

  • Hyoung-Joon Park;Heesung Moon;Min Kyoung Lee;Min Soo Kim;Seok Heo;Chang-Yong Yoon;Sunyoung Baek
    • Analytical Science and Technology
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    • v.36 no.1
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    • pp.22-31
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    • 2023
  • As the use of e-liquid cigarettes is rapidly increasing worldwide, it multiplies the potential risk undisclosed to the health of non- and smokers. To reduce the hazard, each country has its own set of regulations for controlling e-liquids. In Korea, the narrow definition of tobacco makes it difficult and have been steadily occurring tax evasion exploiting the difference in natural and artificial nicotine. Therefore, it is very important to distinguish source of nicotine for their regulation. To find biochemical discriminant markers, this study established analysis methods based on high-performance liquid chromatography coupled with diode array detector (HPLC-DAD) and high-performance liquid chromatography coupled with triple Quadrupole mass spectrometry (HPLC-MS/MS) for nicotine enantiomers and tobacco alkaloids targeted using the difference in pathways of nicotine biosynthesis and chemical synthesis. The method was validated by experimenting linearity (R2 > 0.999), recovery (80.99-108.41 %), accuracy (94.11-109.73 %) and precision (0.04-8.27 %). Then, the results for discrimination of the nicotine obtained from analysis of 65 commercial e-liquid products available in Korean market was evaluated. The method successfully applied to the e-liquids and one sample labelled 'synthetic nicotine' for tax exemption was found to contain a natural nicotine product. This method can be used to determine whether an e-liquid product uses natural or artificial nicotine and monitor non-taxable e-liquid products. The method is more scientific than the existing one, which relies only on field evidence.

Production of Functional Colloids and Fibers from Phase Separation During Electrohydrodynamic Process

  • Jeong, Un-Ryong
    • Proceedings of the Materials Research Society of Korea Conference
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    • 2011.10a
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    • pp.1.2-1.2
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    • 2011
  • Electrohydrodynamics is a good approach to produce uniform-sized colloids and fibers in a continuous process. The dimension can be controlled from tens of nanometers to a few micrometers. The structure of the colloids and nanofibers from electrohydrodynamics has been diversified according to the uses. Especially, core-shell structure and hybridization with functional nanomaterials are fascinating due to their possible uses in drug-delivery systems, multifunctional scaffolds, organic/inorganic hybrids with new functions, and highly sensitive gas- or bio-sensors. This talk will present the structural variations in the colloids and fibers by simply employing phase separation during electrohydrodynamic process and demonstrate their possible applications.

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Patient Compliance and Associated Factors in the Community-based Hypertension Control Program (지역단위 고혈압사업에 있어서 환자의 치료순응도와 결정요인)

  • Kim, Jee;Min, Kyung-Bok;Kwon, Soon-Ho;Han, Dal-Sun;Bae, Sang-Soo
    • Journal of Preventive Medicine and Public Health
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    • v.32 no.2
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    • pp.215-227
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    • 1999
  • Objectives: To investigate compliance of hypertension patients using modified Theory of Reasoned Action(TRA). Methods: The data were collected for 7-12 April 1997, by interviewing 190 Hypertension patients in Hwachon, Kangwon-do. The analytical techniques employed include contingency table analysis and logit analysis. Results: 15.1% of patients were unaware of the fact that he/she has hypertension and 11.2% did not know that he/she should take drug. 20.8% of patients took drug continuously, 20.1% had drug intermittently, and 53.1% had never have treatment. In the contingency table analysis, several variables were found to be significantly related to patient compliance. They included variables for attitude towards the consequences of taking drugs, normative beliefs, systolic BP at the enrollment, knowledge of how to take hypertensive drugs, variables for general health behavior and experience with having health worker's home visit. The logit analysis was performed by two steps. first step uses experience with drug treatment of hypertension as the dependent variable, and second step uses continuity of treatment. Included in the predictors that are significantly related to the former analysis are subjected norms produced by combining normative beliefs and motivation to comply, knowledge of how to take hypertensive drugs, and opinion about natural recovery of diseases. The only significant determinant of continuous treatment was knowledge of how to take hypertensive drugs. Conclusions: The results of analysis suggest the usefulness of TRA as a framework for the study of compliance of hypertensive patients. The findings have some practical implication as well. One is that efforts for enhancing compliance should be directed not only patients but also to other persons influencing patient's attitude and behavior. It also suggest that correct understanding of hypertension treatment is essential to perform the appropriate patient role.

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Drug Use Evaluation of Vancomycin in Hospitalized Patients of Surgery Departments (외과계 입원환자에 대한 Vancomycin의 약물사용 평가)

  • Lee, Young Mee;Choi, Kyung Eob
    • 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.

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Development of Drug Utilization Review Guidelines for Therapeutic Duplication of Antipyretics, Analgesics, and Anti-inflammatory Drugs Registered in Korea (국내 허가된 해열.진통.소염제의 치료중복 주의 가이드라인 개발)

  • Lee, Young-Sook;Kim, Nam-Hyo;Sohn, Hyun-Soon;Choi, Kyung-Eob;Shin, Hyun-Taek
    • Korean Journal of Clinical Pharmacy
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    • v.20 no.3
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    • pp.213-220
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    • 2010
  • Therapeutic duplication (TD) is a serious problem that frequently occurring primarily in the ambulatory setting in Korea. Implementation of concurrent drug utilization review (DUR) is a promising way to reduce inappropriate prescription and dispensing, and improve patient safety. This study was aimed to develop the process of DUR module of TD. Sixty-five drug ingredients classified into the drug category of the antipyretic, analgesic, and anti-inflammatory drug approved in Korea (The KFDA-dess nated classification codes of 114 or 264) were reviewed for this purpose. The drug ingredients (and products) were reclassified based on WHO's Anatomical, Therapeutic and Chemical (ATC) classification system. The clinical practice guidelines, textbooks and product labels on therapeutic uses of these drugs in Korea and several fores n countries were reviewed. If the drugs were categorized into the same therapeutically duplicable class, they were defined not to be used concurrently because the concurrent use was "therapeutically duplicated (unnecessary or even harmful)". Among the studied drug products, the following 5 drug classes were considto beas "therapeutic duplication": (1), on-t tooid DURnti-inflammatory drugs (NSAIDs, including s Dicylates), (2),Anilidts, (3),Opioids, (4) Ergot Dk Doids and (5) 5-$HT_1$ receptor agonot s. Therefore, concurrent prescribing or dispensing of more than 2 drug ingredients any in the above same classes should be considered as TD and needed to be warrant for careful review by pharmacists before dispensing.

THE IMPACT OF STRESS ON ADDICTION

  • Goeders Nick E.
    • Proceedings of the Korean Society of Applied Pharmacology
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    • 2004.11a
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    • pp.18-34
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    • 2004
  • This paper will review data obtained primarily from our preclinical investigations that show that exposure to stress has a significant impact on drug taking. Stress increases reward associated with psychomotor stimulants, possibly through a process similar to sensitization, and a growing clinical literature indicates that there is also a link between substance abuse and stress in human addicts. One explanation for the high concordance between stress-related disorders and drug addiction is the self-medication hypothesis, which suggests that a dually-diagnosed person often uses the abused substance to cope with tension associated with life stressors or to relieve symptoms of anxiety and depression resulting from a traumatic event. However, another characteristic of drug self-administration is that drug delivery and its subsequent effects on the HPA axis are under the direct control of the individual. This controlled activation of the HPA axis may result in the production of an internal state of arousal or stimulation that is actually sought by the individual (i.e., the sensation-seeking hypothesis). During abstinence, however, exposure to stressors or drug-associated cues can stimulate the HP A axis to remind the individual about the effects of the abused substance, thus producing craving and promoting relapse. Stress reduction, either alone or in combination with pharmacotherapies targeting the HPA axis may prove beneficial in reducing cravings and promoting abstinence in individuals seeking treatment for addiction. Of primary importance is to reduce the impact of cocaine-associated environmental stimuli on the HPA axis so that they no longer function as triggers for relapse.

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Co-occurrence Based Drug-disease Relationship Inference with Genes as Mediators (유전자를 중간 매개로 고려한 동시발생 기반의 약물-질병 관계 추론)

  • Shin, Sangwon;Sin, Yeeun;Jang, Giup;Yoo, Youngmi
    • The Journal of Korean Institute of Information Technology
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    • v.16 no.11
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    • pp.1-9
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    • 2018
  • Drug repositioning is to discover new uses of drugs. Text mining derives knowledge from unstructured text. We propose a method to predict new drug-disease relationships by taking into account the rate of frequency of genes simultaneously measured in disease-gene and gene-drug. Co-occurrence of drug-gene and gene-disease in the biological literature is counted and calculate the rate of the gene for each drug and disease. Weights of drug-disease relationships are calculated using the average of the rates of genes that are measured and used to measure the accuracy for each disease. In measuring drug-disease relationships, a more accurate identification of relationships was shown by measuring the frequency on a sentence and considering multiple relationships than existing method.

The Structure-Based Three-Dimensional Pharmacophore Models for Arabidopsis thaliana HPPD inhibitors as Herbicide

  • Cho, Jae Eun;Kim, Jun Tae;Kim, Eunae;Ko, Young Kwan;Kang, Nam Sook
    • Bulletin of the Korean Chemical Society
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    • v.34 no.10
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    • pp.2909-2914
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    • 2013
  • p-Hydroxyphenylpyruvate dioxygenase (HPPD) is a potent herbicide target that is in current use. In this study, we developed a predictive pharmacophore model that uses known HPPD inhibitors based on a theoretically constructed HPPD homology model. The pharmacophore model derived from the three-dimensional (3D) structure of a target protein provides helpful information for analyzing protein-ligand interactions, leading to further improvement of the ligand binding affinity.