• Title/Summary/Keyword: pharmaceutical analysis

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Phytochemical Studies of Phyllanthus debilis

  • Chandrashekar, K.S.;Satyanarayana, D.;Joshi, A.B.;Subrahmanyam, E.V.S.
    • Natural Product Sciences
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    • v.10 no.3
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    • pp.101-103
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    • 2004
  • Two Lignans Phyllanthin and Hypophyllanthin, and a steroid ${\beta}-sitosterol$ has been isolated from the leaves of Phyllanthus debilis and their structures were established by spectral analysis and direct comparison with authentic samples. This is the first report of occurrence of these compound from P.debilis.

Preparation of monoclonal antibodies against berberine and its characterization

  • Kim, Jun-Sik;Tanaka, Hiroyuki;Shoyama, Yukihiro
    • Proceedings of the PSK Conference
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    • 2003.04a
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    • pp.270.1-270.1
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    • 2003
  • Enzyme-linked immunoassay system using monoclonal antibody (MAb) has become an important methodology for the quantitative and qualitative analysis of drugs and phytochemical compounds having small molecular weight. In this study, monoclonal antibodies against berberine, one of main constituent of Phellodendron amurense, Coptis japonica and Corydalis turtschaninovii, were produced. (omitted)

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Impact of Price Control on Drug Expenditure and Factors Associated with the Drug Switch among Statins: Analysis of HIRA-NPS Data (스타틴 의약품의 약가인하 효과 및 약물 교체 관련 요인: 건강보험심사평가원 환자표본자료를 이용한 분석)

  • Lee, Hye-Jae;Lee, Tae-Jin
    • Health Policy and Management
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    • v.23 no.2
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    • pp.112-123
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    • 2013
  • Background: Under the risk of financial sustainability of National Health Insurance, Korean government attempted a series of regulations over pharmaceutical prices. The first price-cut was implemented to the hyperlipidemial treatments, and the prices of statins were reduced on 15th, April in 2009. The purposes of this study are 1) to investigate the impact of this price-cut on pharmaceutical expenditure, and 2) to identify the factors associated with drug-switch among statins. Methods: Using the national patients sample data, this study conducted time series analysis on the expenditures, prices, and volumes of statin drugs. To understand the factors associated with drug-switch, the multinomial logit model was analyzed at the patients level. Results: The results of time series analysis demonstrated that the price-cut of hyperlipidemic medicines did not lead to the reduced expenditure, suggesting the increased volume was the major cause. The multinomial logit analysis identified the switch of healthcare provider as the significant factor that was highly associated with drug-switch, implying the physicians' preference was the major motivation of drug-switch. Conclusion: Without control of utilization, price regulation itself could not reduce pharmaceutical expenditure. This suggests that the pharmaceutical regulations should be implemented on the basis of understanding of provider behaviors. The findings of this study will form the first step for further empirical studies.

Analysis of Financial Performance and Its Factors of Community Pharmacies in Korea: After the Introduction of the Separation of Drug Prescription and Dispensing (SPD) Policy (의약분업이후 약국 경영수지 및 관련 요인 분석)

  • Park, Hye-Kyung;Kwon, Chang-Ik;Eom, Tae-Hoon;Kim, Ye-Soon;Rho, Yeun-Sook;Jeong, Gyu-Hyeok;Lee, Eui-Kyoung
    • YAKHAK HOEJI
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    • v.52 no.6
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    • pp.507-513
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    • 2008
  • The purpose of this study is to analyze the factors affecting financial performance of community pharmacies after the implementation of the new drug policy in Korea: separation of drug prescription and dispensing (SPD). The online survey questionnaires were sent to the active pharmacists of the total 20,633 community pharmacies in Korea and 1,147 pharmacists responded to the survey (the response rate was 5.5%). The questionnaire asked simple financial data in order to compare their financial performances before and after the policy. With the SPSS package (version 12.0), two levels of data analysis were used: 1) descriptive statistics to see the financial status of the pharmacies; and 2) multiple regression analysis to find the factors. {or A multiple regression method was used for the data analysis.} The finding illustrated that the average net benefit of the pharmacies was 4,870 thousand won in August 2006, and the major factors affecting the net benefit were the location of pharmacy (geographical proximity to medical institutions), number of prescriptions, drug management services for patients, chain pharmacy membership. The findings of this study suggest that service improvement for patients, revitalization of non-prescription drug sales, professional management will contribute to promote community based pharmacy business.

Discrimination of Alismatis Rhizoma According to Geographical Origins using Near Infrared Spectroscopy (근적외선분광법을 이용한 택사의 산지 판별법 연구)

  • Lee, Dong Young;Kim, Seung Hyun;Kim, Hyo Jin;Sung, Sang Hyun
    • Korean Journal of Pharmacognosy
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    • v.44 no.4
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    • pp.344-349
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    • 2013
  • Near infrared spectroscopy (NIRS) combined with multivariate analysis was used to discriminate the geographical origin of Alisma orientale from Korea (n=94) and China (n=72). Two-thirds of samples were selected randomly for the training set, and one-third of samples for the test set. Second derivative was used for the pretreatment of NIR spectra. Partial least square discriminant analysis (PLS-DA) models correctly discriminated 100% of the Korean and Chinese A. orientale samples. These results demonstrate the potential use of NIR spectroscopy combined with multivariate analysis as a rapid and accurate method to discriminate A. orientale according to their geographical origin.

Efficacy and Safety of Sorafenib for Advanced Non-Small Cell Lung Cancer: a Meta-analysis of Randomized Controlled Trials

  • Wang, Wei-Lan;Tang, Zhi-Hui;Xie, Ting-Ting;Xiao, Bing-Kun;Zhang, Xin-Yu;Guo, Dai-Hong;Wang, Dong-Xiao;Pei, Fei;Si, Hai-Yan;Zhu, Man
    • Asian Pacific Journal of Cancer Prevention
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    • v.15 no.14
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    • pp.5691-5696
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    • 2014
  • Background: Many clinical trials have been conducted to evaluate sorafenib for the treatment of advanced NSCLC, but the results for efficacy have been inconsistent. The aim of this study was to evaluate the efficacy and safety of sorafenib in patients with advanced NSCLC in more detail by meta-analysis. Methods: This meta-analysis of randomized controlled trials (RCTs) was performed after searching PubMed, EMBASE, ASCO Abstracts, ESMO Abstracts, and the proceedings of major conferences for relevant clinical trials. Two reviewers independently assessed the quality of the trials. Outcomes analysis were disease control rate (DCR), progression- free survival (PFS), overall survival (OS) with 95% confidence intervals (CI) and major toxicity. Subgroup analysis was conducted according to sorafenib monotherapy, in combination with chemotherapy or EGFR-TKI to investigate the preferred therapy strategy. Results: Results reported from 6 RCTs involving 2, 748 patients were included in the analysis. Compared to sorafenib-free group, SBT was not associated with higher DCR (RR 1.31 (0.96- 1.79), p=0.09), PFS (HR 0.82 (0.66-1.02), p=0.07) and OS (HR 1.01 (0.92-1.12), p=0.77). In terms of subgroup results, sorafenib monotherapy was associated with significant superior DCR and longer PFS, but failed to show advantage with regard to OS. Grade 3 or greater sorafenib-related adverse events included fatigue, hypertension, diarrhea, oral mucositis, rash and HFSR. Conclusions: SBT was revealed to yield no improvement in DCR, PFS and OS. However, sorafenib as monotherapy showed some activity in NSCLC. Further evaluation may be considered in subsets of patients who may benefit from this treatment. Sorafenib combined inhibition therapy should be limited unless the choice of platinum-doublet regimen, administration sequence or identification of predictive biomarkers are considered to receive better anti-tumor activity and prevention of resistance mechanisms.

Establishment of Quantitative Method for Generic Drugs in Korea Pharmaceutical Codex Monograph (공정서 수재 의약품의 정량법 개선에 관한 연구)

  • Song, JaeYong;Jang, JinSeob;Jang, SeungEun;Kim, SunHoi;Kim, InKyu;Lee, GilBong;Lee, JeaMan;Kim, YongHee
    • YAKHAK HOEJI
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    • v.56 no.5
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    • pp.288-292
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    • 2012
  • The aim of the paper is to ameliorate old research methods of Korean Pharmaceutical Codex to adjust the newest scientistic level which is necessary to maintain quality of medical supplies effectively. After reviewing result of Establishment of Dissolution Specifications for Generic Drugs in Korea Pharmaceutical Codex Monograph, there are two items chosen for the methods - Establishment of Dissolution Specifications for Generic Drugs in Korea Pharmaceutical Codex Monograph which KFDA researched in 2010, arranged new measuring standard by having an experiment to set measuring method after obtaining each item. According to the result, The experiment includes a measuring method of two items; Nafronyl Oxalate Capsules, and Ticlopidine Hydrochloride Tablets. The research is ameliorated by research methods through several experiments such as High Performance Liquid Chromatography validation, preparing items, implement of trial-experiment and authentic experiment, and experiment on measuring method of regulations of Korea Pharmaceutical Codex. The experiments are taken opinions of experts in KFDA into consideration and wrote out a report of the new measuring method on each last item. The report is combined as each two experiment sections of analyzing method to maintain the quality on the basis of the research in 2010 on setting of dissolution specifications for oral solid dosage forms. The result of measuring method of medical supplies through modernizing trial method of oral solid dosage forms is available to be accurate. In conclusion, this study could contribute to promotion of public health by organizing a basis for safe and high quality of medical supplies in domestic market.

Statistical Analysis on the Sources of Variance in Proficiency Test of Quantitative Analysis of Medicines (의약품 함량분석 정도관리에서의 변이 요인에 대한 통계분석)

  • Cho, Jung-Hwan
    • Journal of Pharmaceutical Investigation
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    • v.37 no.1
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    • pp.27-37
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    • 2007
  • Proficiency test is an essential tool far ensuring analytical ability of analytical chemists and analytical institutes. Usually, the standard protocol for proficiency test is focused on acceptability of reported analytical results of participants by calculating z-scores and related diagnostic parameters. The ultimate goal of this process is to reveal the sources of variability of analytical results and to find the way to reduce their influence. In this study, the method of analysis of variance (ANOVA) was applied to the analytical data collected from qualify control departments of pharmaceutical companies in KyungIn province in Korea in the year of 2000. As influencing factors of variability of analytical results, the use of internal standards for liquid and gas chromatograpy, the educational and professional background of participants, geological locations and yearly production sizes of participating companies were evaluated. To evaluate the variability in accuracy of analytical results, absolute differences from sample mean and sample median were used and to evaluate variability in precision of individual participants, the reported standard deviation of each participant was used. As a result, the use of internal standards in gas chromatographic analysis, participants' academic background and the yearly production sizes of pharmaceutical companies showed statistically significant influence to the accuracy and the precision of the reported analytical results used in this study.

Perspectives on the Quality Assurance of Ginseng Products in North America

  • Fitzloff, J.F.;Yat, P.;Lu, Z.Z.;Awng, D.V.C.;Arnason, J.T.;Breemen, R.B.van;Ha, T.ll;Blumenthal, M.;Fong, H.H.S.
    • Proceedings of the Ginseng society Conference
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    • 1998.06a
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    • pp.138-145
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    • 1998
  • A validated and reproducible HPLC method was developed for the profiling and quantitative analysis of ginsenosides in commercial products available in North America. Analysis of 280 Panax ginseng and Panax quinquefolius products showed profiles indicative of the presence of ginsenosides in the majority of these products. However, the quantitative contents of the products vary greatly, not only in products of different formulations, but also of products within each of the fromulations examined.

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