• Title/Summary/Keyword: Drug Review

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Comparison of Clinical Development and Evaluation of Triple Antihypertensive Therapy in Advanced Foreign Countries (항고혈압 약물 3종 복합제에 대한 선진 외국의 임상자료 심사사례 비교)

  • Wang, So Young;Shon, Soo Jung;Um, Jung Yoon;Lim, Hwa Kyung;Lim, Sook;Kang, Seung Ho;Lee, Sun Hee
    • Korean Journal of Clinical Pharmacy
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    • v.23 no.3
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    • pp.239-247
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    • 2013
  • Background: Fixed drug combinations are formulations containing two or more active ingredients in a single dosage form. Such combination therapies are commonly applied to improve efficacy, reduce adverse events and replace co-administration, etc. National and international guidelines for hypertension treatment recommend addition of other classes of antihypertensive drugs rather than incremental dose of mono-therapy, when blood pressure is not adequately controlled. Thus, many dual combinations of antihypertensive drugs have been approved and pharmaceutical companies are recently interested in developing antihypertensive triple combinations. Clinical trial designs for the fixed combinations are various depending on the target patients, dosage and clinical endpoints. Thereby, further discussions for the clinical trials of antihypertensive triple therapies are required regarding the indication claimed. Conclusion: This article provides a review for the assessment of the label and medical reports of the clinical trials on antihypertensive triple therapies in advanced foreign countries.

Long Non-coding RNAs and Drug Resistance

  • Pan, Jing-Jing;Xie, Xiao-Juan;Li, Xu;Chen, Wei
    • Asian Pacific Journal of Cancer Prevention
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    • v.16 no.18
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    • pp.8067-8073
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    • 2016
  • Background: Long non-coding RNAs (lncRNAs) are emerging as key players in gene expression that govern cell developmental processes, and thus contributing to diseases, especially cancers. Many studies have suggested that aberrant expression of lncRNAs is responsible for drug resistance, a substantial obstacle for cancer therapy. Drug resistance not only results from individual variations in patients, but also from genetic and epigenetic differences in tumors. It is reported that drug resistance is tightly modulated by lncRNAs which change the stability and translation of mRNAs encoding factors involved in cell survival, proliferation, and drug metabolism. In this review, we summarize recent advances in research on lncRNAs associated with drug resistance and underlying molecular or cellular mechanisms, which may contribute helpful approaches for the development of new therapeutic strategies to overcome treatment failure.

An Integrative Approach to Precision Cancer Medicine Using Patient-Derived Xenografts

  • Cho, Sung-Yup;Kang, Wonyoung;Han, Jee Yun;Min, Seoyeon;Kang, Jinjoo;Lee, Ahra;Kwon, Jee Young;Lee, Charles;Park, Hansoo
    • Molecules and Cells
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    • v.39 no.2
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    • pp.77-86
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    • 2016
  • Cancer is a heterogeneous disease caused by diverse genomic alterations in oncogenes and tumor suppressor genes. Despite recent advances in high-throughput sequencing technologies and development of targeted therapies, novel cancer drug development is limited due to the high attrition rate from clinical studies. Patient-derived xenografts (PDX), which are established by the transfer of patient tumors into immunodeficient mice, serve as a platform for co-clinical trials by enabling the integration of clinical data, genomic profiles, and drug responsiveness data to determine precisely targeted therapies. PDX models retain many of the key characteristics of patients' tumors including histology, genomic signature, cellular heterogeneity, and drug responsiveness. These models can also be applied to the development of biomarkers for drug responsiveness and personalized drug selection. This review summarizes our current knowledge of this field, including methodologic aspects, applications in drug development, challenges and limitations, and utilization for precision cancer medicine.

Combined nano-particle drug delivery and physiotherapy in treatment of common injuries in dance-sport

  • Weixin Dong;Gang Lu;Yangling Jiang;Fan Zhou;Xia Liu;Chunxia Lu
    • Advances in nano research
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    • v.15 no.3
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    • pp.225-237
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    • 2023
  • Combination of novel technologies with traditional physiotherapy in rehabilitation in injured athletes have shown to provide improved time of recovery. In specific, nanodrugs delivery systems are widely utilized as a counterpart to the physiotherapy in injuries in sports. In the present study, we focus on the common injuries in dance-sports, their recovery and the effect combination of nano-particle drug delivery with the physiotherapy practices. In this regard, a comprehensive review on the common injuries in dance sport is provided. Moreover, the researches on the effectiveness of the nano-particle drug delivery in therapy of such injuries and in similar cases are provided. The possibility of using combination of nano-particle drug delivery and physiotherapy is discussed in detail. Finally, using artificial intelligence methods, predictions on the recovery time and after-treatment side-effects is investigated. Artificial Neural Network (ANN) predictions suggested that using nano-particle drug delivery systems along with physiotherapy practices could provide shortened treatment time to recovery in comparison to conventional drugs. Moreover, the post-recover effects are less than the conventional methods.

Hepatotoxic Events Associated with Herbal Medicinal Products, Folk Remedies and Food Supplements in Korea (국내에서 보고된 한약 및 민간요법, 건강식품 관련 약인성간손상에 대한 체계적 고찰)

  • Park, Hae-Mo;Jang, In-Soo;Lee, Sun-Dong
    • The Journal of Korean Medicine
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    • v.26 no.2 s.62
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    • pp.152-165
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    • 2005
  • Background: The use of herbal preparations as remedies for various medical conditions has continuously increased in Korea Large proportions of Korean patients use herbal medicinal products, folk remedies, and food supplements. However, studies on the safety of herbal products arc conducted on a less than sufficient basis even in the countries like Korea where herbal medicine is being used extensively. Some of the reports on the safety of herbs were done by the doctors of western medicine but lack of knowledge and misclassification led to misunderstandings. Objecitves: This study aims to review the recent evidences on hepatotoxic events associated with the use of herbal medicinal products, folk remedy, and food supplements. In the process, this review will grasp trends in this field of studies and will direct further researches into the right direction. Methods: Systematic literature searches were performed on MedRic and MEDLIS in Korea. Screening and selection of the articles and the extraction of data were performed independently by two of authors. There were no restrictions regarding the published date. In order to avoid bias, the articles written by medical doctors, not by oriental doctors were selected. 43 journals were chosen for the review. Results: Analyzing the number of journals, studies on the drug-induced liver injury were increased after the year 2000. The proportion of herbal and folk remedy associated hepatotoxic injuries in all drug-induced liver injury was $21.0\%-30.0\%$. But criterion for herbal medicine is rather vague and limited objective data hindered objectiveness. Few of single medicinal herbs and combination preparations were associated with hepatotoxic injuries. But because of lack of objectivity, further researches must be conducted to yield more concrete results. Conclusions: yield more concrete results. Incidence figures are largely unknown, and in most cases a causal attribution is not established. The challenge for the future is to systematically research this area, educate all parties involved, and minimize patient risks.

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Trends and Appropriateness of Outpatient Prescription Drug Use in Veterans (보훈의료지원 대상자의 외래 처방의약품 사용경향과 적정성 평가)

  • Lee, Iyn-Hyang;Shim, Da-Young
    • Korean Journal of Clinical Pharmacy
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    • v.28 no.2
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    • pp.107-116
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    • 2018
  • Objective: This study analyzed the national claims data of veterans to generate scientific evidence of the trends and appropriateness of their drug utilization in an outpatient setting. Methods: The claims data were provided by the Health Insurance Review & Assessment (HIRA). Through sampling and matching data, we selected two comparable groups; Veterans vs. National Health Insurance (NHI) patients and Veterans vs. Medical Aid (MAID) patients. Drug use and costs were compared between groups by using multivariate gamma regression models to account for the skewed distribution, and therapeutic duplication was analyzed by using multivariate logistic regression models. Results: In equivalent conditions, veteran patients made fewer visits to medical institutions (0.88 vs. 1), had 1.86 times more drug use, and paid 1.4 times more drug costs than NHI patients (p<0.05); similarly, veteran patients made fewer visits to medical institutions (0.96 vs. 1), had 1.11 times more drug use, and paid 0.95 times less drug costs than MAID patients (p<0.05). The risk of therapeutic duplication was 1.7 times higher (OR=1.657) in veteran patients than in NHI patients and 1.3 times higher (OR=1.311) than in MAID patients (p<0.0001). Conclusion: Similar patterns of drug use were found in veteran patients and MAID patients. There were greater concerns about the drug use behavior in veteran patients, with longer prescribing days and a higher rate of therapeutic duplication, than in MAID patients. Efforts should be made to measure if any inefficiency exists in veterans' drug use behavior.

Detection of Adverse Drug Reactions Using Drug Reviews with BERT+ Algorithm (BERT+ 알고리즘 기반 약물 리뷰를 활용한 약물 이상 반응 탐지)

  • Heo, Eun Yeong;Jeong, Hyeon-jeong;Kim, Hyon Hee
    • KIPS Transactions on Software and Data Engineering
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    • v.10 no.11
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    • pp.465-472
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    • 2021
  • In this paper, we present an approach for detection of adverse drug reactions from drug reviews to compensate limitations of the spontaneous adverse drug reactions reporting system. Considering negative reviews usually contain adverse drug reactions, sentiment analysis on drug reviews was performed and extracted negative reviews. After then, MedDRA dictionary and named entity recognition were applied to the negative reviews to detect adverse drug reactions. For the experiment, drug reviews of Celecoxib, Naproxen, and Ibuprofen from 5 drug review sites, and analyzed. Our results showed that detection of adverse drug reactions is able to compensate to limitation of under-reporting in the spontaneous adverse drugs reactions reporting system.

Study on the Application of Established Korean Medical Classics in the Korean Pharmaceutical Affairs Act (약사법규 중의 기존한약서 활용에 대한 고찰)

  • Eom, Seok-ki
    • The Journal of Korean Medicine
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    • v.35 no.3
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    • pp.135-154
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    • 2014
  • Purpose: There is an issue in applying various principles introduced in established Korean medical classics to "Pharmaceuticals Approval, Notification and Review" of "herbal medicinal preparations" and "new drugs from natural products" that are used for western forms of medical treatment. Thus, an analysis of the origin, purpose, and application of established Korean medical classics in the Korean Pharmaceutical Affairs Act is essential. Methods: We collected data regarding the origin, purpose, and application of established Korean medical classics in the Korean Pharmaceutical Affairs Act, and classified them by periodical change and subjects. Results: Established Korean medical classics are applied as follows: 1) as criteria for Korean medicine distributors' sales of mixed herbal drugs (Pharmaceutical Affairs Act; since 1953), 2) as official compendiums for pharmacists' preparation of Korean medicine (Ministry of Health and Welfare's authoritative interpretation; from early 1970s to 1993), 3) as standards for oriental pharmacists' quality measurement of preparations (notification of the Ministry of Health and Welfare; since 1995), 4) as criteria for "Pharmaceuticals Approval, Notification and Review" of herbal medicinal preparations and crude drug preparations (notifications regarding drug approval process by the Ministry of Health and Welfare and the Ministry of Food and Drug Safety; since 1978), and 5) as standards for the quality of materials of health functional food (from 2004 to 2011). Conclusion: The application of Korean medical classics has been closely related with the change of the laws, regulations, and systems that are relevant to Korean medicine, and it seems to be more favorable for pharmacists than oriental pharmacists. Meanwhile, regulations that apply prescriptions that are recorded in Korean medical classics - dosage, indications, and preparation methods - as criteria for the approval of crude drug preparations for western medical treatment should be abolished.

Systemic Review of Pramlintide, a New Drug for the Treatment of Diabetes Mellitus (새로운 당뇨병 치료제 Pramlintide의 Systematic Review)

  • Shanmugam, Srinivasan;Jung, Hee-Yong;Yong, Chul-Soon;Choi, Han-Gon;Kim, Jung-Ae;Yoo, Bong-Kyu
    • YAKHAK HOEJI
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    • v.50 no.6
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    • pp.386-392
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    • 2006
  • Pramlintide, a synthetic analogue of human hormone amylin, is the first of a new class of amylinomimetic compounds. Present study was undertaken to compile and analyze the clinical trials of pramlintide, and thereby to facilitate the design of the bridging study for the earlier introduction of the drug, which might be needed by diabetes patients in Korea. Sixty-two articles from Pubmed and MEDLINE search were used to analyze the trials of pramlintide along with prescribing information and New Drug Application packet obtained form the manufacturer. The efficacy of the new drug was attributed to three mechanisms: delay of gastric emptying time, inhibition of post-prandial glucagon secretion, and reduction of food intake by enhanced satiety. Clinical trials consistently identified the effectiveness of the drug for the treatment of type 1and type 2 diabetes who have failed to achieve glycemic control despite optimal therapy with insulin. However, the six pivotal Phase III clinical trials were peformed with mostly caucasian and some black and hispanic people. None of the trials documented the proportion of either Asian or Korean participants. Since Korean diabetes patients show different epidemiology and characteristics in their disease state, it appears that the bridging study of pramlintide should be designed in the level of full scale Phase III clinical trial along with pharmacokinetic and pbarmacodynamic studies.