• 대한임상약리학회:학술대회논문집
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• 1999.12a
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• pp.36-36
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• 1999

• 대한임상약리학회:학술대회논문집
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• 2001.06a
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• pp.23-28
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• 2001

• Korea Journal of Hospital Management
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• v.14 no.4
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• pp.52-70
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• 2009

This study is to analyse the reimbursement prices of drugs in Japan. Japan has the world's second-largest pharmaceutical market, and the world's largest price-controlled pharmaceutical market. The reimbursement prices of new drugs in Japan are determined by confidential negotiations between the manufacturer and the Japanese Ministry of Health, Labor, and Welfare. Pharmaceuticals account for a larger share of total healthcare expenditures in Japan than in most other major pharmaceutical markets such as France, Germany, United Kingdom and United States. Prescription drugs' share of total healthcare spending has slightly increased in recent years, from 20.2% in 2000 to 21.5% in 2004, the most recent year for which data are currently available. This trend is attributable to the effect of the Japanese rapidly aging population that stimulates demand for healthcare services. There are several method of price setting for drugs as below. First, on the initial pricing of branded drugs, is the similar-efficacy pricing method and cost calculation method. Second is postmarketing price changes which are biennial price revisions under the rule of National Health Insurance. Third is the rule of the generics price. Recently, the generics market is expanded because there are increasing numbers of hospitals by DPCs(Diagnosis-procedure Combinations).

• Journal of Korean Medicine Rehabilitation
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• v.30 no.4
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• pp.133-142
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• 2020

Objectives Studies on Chinese herbal injections are increasing. But, its safety are still not well reported. We have reviewed the literature related to the safety of Chinese herbal injection, especially those related to anaphylaxis. Methods The PubMed database was used to select the literatures related to anaphylaxis in China and to study the quality control and safety of Chinese herbal injection. Results Chinese herbal injection is a major traditional medical treatment in China, but it is the cause of adverse drug reactions including anaphylaxis. In order to solve this problem, various proposals have been made to identify the pharmacological and chemical causes of major side effects and to use them safely clinically. In addition, various researches have been conducted from preclinical to postmarketing surveillance to secure the safety of Chinese herbal injection. Based on this, it was found that various efforts are needed to secure the safety of bee sting needles. Conclusion In order to secure the safety of chinese herbal injections, it is necessary to identify the main mechanism of action and the pharmacological components contributing to it, and to develop a standardized formulation based on this. In addition, institutional pharmacovigilance is required.

• Journal of Preventive Medicine and Public Health
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• v.40 no.4
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• pp.278-284
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• 2007

Despite extensive researches and pre-market clinical trials, only limited information on the adverse drug reactions (ADRs) of a drug can be collected at the time of market approval from regulatory agency. ADRs constitute a major public health problem. Post-marketing surveillance of drugs is important to detect signals for ADR. In Korea, one of the main methods for monitoring the safety of marketed drugs is spontaneous reporting system of suspected ADRs. Re-examination and re-evaluation system are in force for monitoring safety of new market approval drugs and currently under marketing drugs, respectively. Recently, regional pharmacovigilance centers were designated from Korean Food and Drug Administration for facilitating ADR surveillance. Over recent years, with the development of information technology, there has been an increased interest in establishing data mining system for detecting signals from Health Insurance Review Agency database. The purpose of this paper is to review the current status of Korean ADR surveillance system and suggest the possible solutions for developing active pharmacovigilance system in Korea.

• Korean Journal of Bronchoesophagology
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• v.9 no.1
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• pp.60-66
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• 2003

Although there is a wide range of diseases caused by gastric acid reflux and the number of cases is on the rise, it is difficult for the laryngologist to make the correct diagnosis. The treatment for laryngopharyngeal reflux can be grouped into 3 categories - changes in lifestyle, medication, and surgery. The medication used to treat laryngopharyngeal reflux are prokinetic agents and acid supressive agents such as antacids, H2 blockers, and PPIs(Proton pump inhibitor). Rabeprazole sodium($Pariet^{\circledR}$) is a newly developed agent belonging to the PPI group, but in contrast with the existing drugs such as omeprazole, lansoprazole, pantoprazole, has a low dependency on CYP2C19 during the metabolic cycle. Thus, it is known to have a quick but fixed antiacid effect and less individual differences. We analyzed 2166 patients from 32 hospitals who were prescribed $Pariet^{\circledR}$ from May, 2001 to April, 2002. The patients were divided into 4 groups according to the duration of treatment - Group 1: 1-14 days, Group 2: 15-28 days, group 3: 29-56 days, Group 4: more than 56 days. The cases were then analyzed for improvement of 8 symptoms(heart bum, regurgitation, chronic cough, hoarseness, globus sensation, chronic throat clearing, sore throat, and dysphagia), improvement on laryngoscope, usefulness to the doctor, and complication development. Of the total of 2116 patients, 1627(75.1%) cases showed at least 50% improvement of symptoms and the amount of improvement increased according to the duration of medical treatment. Most of the patients showed objective improvement on the laryngoscope, with 32.9% showing significant improvement and 38.7% showing moderate improvement. 37.6% of the doctors questioned replied that $Pariet^{\circledR}$ was very useful and 50.3% said it was useful, showing that most were satisfied with the treatment results. The complications known to develop after taking PPI are headache, nausea, diarrhea, abdominal pain, constipation, dizziness, fatigue, and of these, only a small percentage of the patients complained of mild headache. $Pariet^{\circledR}$ has shown to be a relatively safe and effective drug for the treatment of laryngopharyngeal reflux.

• Tuberculosis and Respiratory Diseases
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• v.86 no.1
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• pp.33-46
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• 2023

Background: Umeclidinium/vilanterol (UMEC/VI; ANORO ELLIPTA, GSK) is a commonly used dual bronchodilator. This study evaluated the safety and effectiveness of UMEC/VI in Korean patients with chronic obstructive pulmonary disease (COPD) over a 6-year period. Methods: This was an open-label, multicentre, observational, post-marketing surveillance study. A total of 3,375 patients were enrolled consecutively in 52 hospitals, by 53 physicians, between July 2014 and July 2020. Patients who were administered UMEC/VI (fixed-dose 62.5 ㎍/25 ㎍) at least once and were monitored for safety and effectiveness were included in the analysis. Incidence and severity of adverse events (AEs) reported after administrating at least one dose of UMEC/VI were monitored, including unexpected adverse events (UAEs) and adverse drug reactions (ADRs). Effectiveness of UMEC/VI after 24 weeks of administration was also assessed using physician's evaluation (effective, ineffective/no change, worsening, indeterminable) and lung function improvement. Results: Of 3,375 patients, 3,086 were included in the safety assessment group (mean age±standard deviation: 69.76±8.80 years; 85.9% male [n=2,652]; 73.1% aged ≥65 years [n=2,255]). The overall incidence of AEs was 28.8% (n=890), of which 2.2% (n=67) were ADRs. Serious AEs and UAEs were reported in 181 (5.9%) and 665 (21.6%) patients, respectively, and two patients (<0.1%) reported unexpected severe ADR. Of the 903/3,086 patients analysed for effectiveness, most (82.8%, n=748) showed overall disease improvement after UMEC/VI treatment. Conclusion: This study confirmed UMEC/VI administered to Korean patients according to the prescribing information was well-tolerated and can be considered an effective option for COPD treatment.

• Korean Journal of Clinical Pharmacy
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• v.34 no.2
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• pp.134-139
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• 2024

Background: Increasing numbers of studies and research about artificial intelligence (AI) and machine learning (ML) have led to their application in clinical trials. The purpose of this study is to analyze computer-based new technologies (AI/ML) applied on clinical trials registered on ClinicalTrials.gov to elucidate current usage of these technologies. Methods: As of March 1st, 2023, protocols listed on ClinicalTrials.gov that claimed to use AI/ML and included at least one of the following interventions-Drug, Biological, Dietary Supplement, or Combination Product-were selected. The selected protocols were classified according to their context of use: 1) drug discovery; 2) toxicity prediction; 3) enrichment; 4) risk stratification/management; 5) dose selection/optimization; 6) adherence; 7) synthetic control; 8) endpoint assessment; 9) postmarketing surveillance; and 10) drug selection. Results: The applications of AI/ML were explored in 131 clinical trial protocols. The areas where AI/ML was most frequently utilized in clinical trials included endpoint assessment (n=80), followed by dose selection/optimization (n=15), risk stratification/management (n=13), drug discovery (n=4), adherence (n=4), drug selection (n=1) and enrichment (n=1). Conclusion: The most frequent application of AI/ML in clinical trials is in the fields of endpoint assessment, where the utilization is primarily focuses on the diagnosis of disease by imaging or video analyses. The number of clinical trials using artificial intelligence will increase as the technology continues to develop rapidly, making it necessary for regulatory associates to establish proper regulations for these clinical trials.