• Title/Summary/Keyword: Pharmaceutical analysis

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Studies on Determination of Aliphatic Carbamates -Quantitative Analysis of Carisoprodol-

  • Kim, Jeoung-Sook;Kim, Bak-Kwang
    • Journal of Pharmaceutical Investigation
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    • v.15 no.3
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    • pp.151-159
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    • 1985
  • For the determination of aliphatic carbamates, the quantitative analysis of carisoprodol was investigated by gab chromatography (GC) and spectrophotometry. All the methods studied were found to be very quantitative. The minimum experimental amounts of GC method, spectrophotometric method I and II were approximately $10^{-9},\;10^{-5}$ and $10^{-8}$ mole, respectively. The obtained results showed that GC method I was much more sensitive and rapid than spectrophotometric method II.

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Stability Analysis of Ampicillin Trihydrate in Solid-State (고체상태에서 Ampicillin Trihydrate의 안정성에 관한 연구)

  • 김종국;곽효성;신희종
    • YAKHAK HOEJI
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    • v.25 no.1
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    • pp.37-42
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    • 1981
  • Penicillin derivatives have a stability problem by hydrolysis of their .betha.-lactam ring. At high temperature, crystal water is released from penicillin derivatives, especially ampicillin trihydrate and concerns itself in hydrolysis. Penicillin derivatives having crystal water show different crystal states and different stability according to the variation of different condition on the process of manufacturing. The stability of ampicillin trihydrate in solid states was determined. Physico-pharmaceutical properties of this compound were determined by using IR spectra, X-ray powder diffraction and differential thermal analysis (DTA).

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A study on analysis of particle size distribution

  • Min, Shin-Hong
    • Archives of Pharmacal Research
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    • v.3 no.2
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    • pp.65-74
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    • 1980
  • Analysis of particle size distribution of a sample of fine aluminum hydroxide powder was carried out by four different methods, i. e., conductivity, air permeability, gas-adsorption and sedimentation. Each method was reproducible. The results obtained by Coulter counter and sedimentation balance were similar, and the data obtained by Lea and Nurse permeameter and Stroehlein areameter were also similar. But the results differ considerabley between the former and the latter. The advantages and disavantages of each method were discussed briefly and a means of comparing the results with those obtianed by surface area measurements was shown.

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Intranasal Insulin for Alzheimer's Disease and Amnestic Mild Cognitive Impairment: Systematic Review and Meta-analysis (알츠하이머병 및 건망증 경도 인지장애의 인슐린 비강투여: 체계적 문헌 고찰 및 메타분석)

  • Alnajjar, Sarah;Jin, Hye Kyung;Kang, Ji Eun;Park, So Hyun;Rhie, Sandy Jeong
    • Korean Journal of Clinical Pharmacy
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    • v.27 no.3
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    • pp.161-170
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    • 2017
  • Background: There is recent evidence that insulin resistance is responsible for increasing the risk of developing cognitive dysfunction. To systematically review the influence of intranasal insulin treatment on the cognitive function in Alzheimer's disease patients. Methods: Randomized controlled trials comparing the cognitive effects of intranasal insulin therapy in Alzheimer's disease patients with controlled interventions were retrieved from Pubmed, Medline, Embase and Cochrane library. Meta-analysis was conducted on the cognitive measurements with a subgroup analysis by dose, gender and apolipoprotein E allele 4 (ApoE ${\varepsilon}4$) status. Results: Seven randomized controlled trials were eligible for inclusion. Intranasal insulin had a positive influence on the cognitive function as compared to placebo without a statistical significance (standardized mean difference; SMD = 0.109; 95% confidence interval; CI -0.04 to 0.26; P=0.14). In subgroup analysis, a 20 IU dose of intranasal insulin induced a significant improvement in cognitive function (SMD = 0.14; 95% CI 0.05 to 0.24; P=0.004), but 40 IU did not show this effect (SMD = -0.01; 95% CI -0.11 to 0.09; P=0.82). ApoE ${\varepsilon}4$ positive patients showed a significant decline in cognitive function as compared to ApoE ${\varepsilon}4$ positive patients in the control group (SMD = -0.213; 95% CI -0.38 to -0.04; P=0.015). Such an effect was not apparent in ApoE ${\varepsilon}4$ negative patients. Gender had no influence on the cognitive outcomes. Conclusion: The results indicate that intranasal insulin may have beneficial effect in improving the cognitive function in Alzheimer's disease patients.

An Empirical Study on the Relationship between Corporate and Radical Innovation based on Patent Information (특허 정보를 이용한 기업의 급진적 혁신에 관한 실증연구)

  • Jeon, Suyeon
    • Journal of the Korea Academia-Industrial cooperation Society
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    • v.21 no.10
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    • pp.471-479
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    • 2020
  • In this paper, we analyze features of radical innovative businesses using their patents. Although patents have been used to evaluate outcomes of businesses from the 1980s, it is challenging to use patents for radical innovations. We examined the possibility of taking advantage of patents for an indicator that represents a radical innovation in pharmaceutical industry. To this end, we collected FDA approval data from the U.S. Food and Drug Administration and patent data of 18 pharmaceutical companies. For analysis, we utilized the network centrality analysis and Wilcoxon signed ranked test, which is a non-parametric statistical hypothesis test used to compare two related samples. We observed that a radical innovative company typically cooperates with other research groups, such as universities and companies, and acts as a hub for connectivity in pharmaceuticals. Also, we found that there are differences in centrality between radical firms and non-radical firms. Thus, we expect that the results of this study will help in developing strategies for research and development of pharmaceutical companies and identifying factors affecting radical innovation in the future.

Textural Characterization of Gel Layer Thickness and Swelling Boundary in a Hydrophilic Compact (친수성 정제의 겔층두께와 겔팽창 영역의 조직 특성화)

  • Kim, Hyun-Jo;Fassihi, Reza
    • Journal of Pharmaceutical Investigation
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    • v.31 no.1
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    • pp.13-18
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    • 2001
  • This study was to investigate the relationship between the gel layer thickness and swelling boundary via strength measurements using texture analysis. The novel texture analysis approach was used to examine the dynamics of swelling behavior in a ternary polymeric matrix tablet. The method permitted the characterization of the changes occurring at the peripheral as well as within interior boundary of the swelling during water ingress. The increase in gel strength for pectin, HPMC, and a ternary mixture with gelatin was found to depend on polymer concentration. Therefore, this method is further applicable to characterize the swelling behavior and provide opportunity to differentiate the gel-layer from that of swelling boundary.

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A Comparative Analysis of Barriers for Korean Pharmaceutical Companies in Global Regulatory Affairs by Company Size (기업 규모별 의약품 해외 인허가 과정에서의 장애요인 비교분석)

  • Hong, Yoon-Na;Ha, Dong-Mun
    • The Korean Journal of Health Service Management
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    • v.14 no.1
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    • pp.55-65
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    • 2020
  • Objectives: To provide guidance for agency planning by identifying barriers faced by Korean pharmaceutical companies in global regulatory affairs. Methods: A questionnaire survey on global regulatory affairs was administered by email to personnel at Korean pharmaceutical companies. From a total of 60, 28 responses were collected. Respondents' companies were classified as small-sized or large-sized, based on whether their annual sales amounted to KRW 100 billion. Results: Small-sized companies were experiencing greater difficulties in receiving drug approvals from advanced countries, particularly during the Investigational New Drug (IND) and Good Manufacturing Practice (GMP) processes. Conclusions: Support measures to specifically help small-sized companies enter more advanced markets and further improved global regulatory guidelines that can meet large-sized companies' expectations are needed. Moreover, domestic and global regulatory standards should be harmonized to benefit both groups.

Critical Review of health care economic evaluation methodology : With a special reference to study design and cost estimation (보건의료 경제성 평가 방법론 고찰 -연구 설계와 비용 추정을 중심으로-)

  • ;Brouwer WBF
    • Health Policy and Management
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    • v.14 no.2
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    • pp.58-77
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    • 2004
  • Cost containment has become high political issues since financial crisis of the Korean Health Insurance fund in 2000. Korean Government has developed and implemented several measures to reduce the pharmaceutical expenditures. Pharmaceutical economic evaluation can be a tool in decision to allocate scare resource efficiently. In order to increase the quality of economic evaluation for pharmaceuticals, the Korean Health Insurance Review Agency(HIRA) is considering the development of a guideline for economic evaluation. It mandates that pharmaceutical companies could submit the result of an economic evaluation when demanding reimbursement of new pharmaceutical drugs. The purpose of this study is to provide a critical review of the economic evaluations of health care technologies published in the Korean context whether they have been performed according to current guidelines and therefore whether their results are directly useful for decision making. We found there exist important problems and deviation from, good practice' both in the general features of the studies, like the study design and perspective, and in terms of cost measurement and valuation. There are needs to develop clear guidelines and to educate and train researchers in performing economic evaluations.

Characterization of RbmD (Glycosyltransferase in Ribostamycin Gene Cluster) through Neomycin Production Reconstituted from the Engineered Streptomyces fradiae BS1

  • Nepal, Keshav Kumar;Oh, Tae-Jin;Subba, Bimala;Yoo, Jin Cheol;Sohng, Jae Kyung
    • Molecules and Cells
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    • v.27 no.1
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    • pp.83-88
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    • 2009
  • Amino acid homology analysis predicted that rbmD, a putative glycosyltransferase from Streptomyces ribosidificus ATCC 21294, has the highest homology with neoD in neomycin biosynthesis. S. fradiae BS1, in which the production of neomycin was abolished, was generated by disruption of the neoD gene in the neomycin producer S. fradiae. The restoration of neomycin by self complementation suggested that there was no polar effect in the mutant. In addition, S. fradiae BS6 was created with complementation by rbmD in S. fradiae BS1, and secondary metabolite analysis by ESI/MS, LC/MS and MS/MS showed the restoration of neomycin production in S. fradiae BS6. These gene inactivation and complementation studies suggested that, like neoD, rbmD functions as a 2-N-acetlyglucosaminyltransferase and demonstrated the potential for the generation of novel aminoglycoside antibiotics using glycosyltransferases in vivo.

A Comparative Study on the Herbal Prescription and the Herbal Substance of Atractylodis Rhizoma Alba by HPLC analysis (한약제제 백출(白朮)과 한약재 백출에 대한 HPLC 분석 비교연구)

  • Cho, Hyun Joo;Jeon, Yoon Jae;Kim, Nam-Gil;Choi, Hyug-Yong
    • Herbal Formula Science
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    • v.24 no.2
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    • pp.71-79
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    • 2016
  • Objectives : To verify the equivalence between Atractylodis Rhizoma Alba herbal prescription(HP-ARA) and Atractylodis Rhizoma Alba herbal sub stance(HS-ARA). Methods : Safety tests by microbial regulation and heavy metal analysis (total heavy metal, Pb, As) and a stability test by long term shelf test for HP-ARA according to notification of the Ministry of Food and Drug Safety were carried out. Then, multi component profile of HP-ARA and HS -ARA were analyzed by HPLC. Results : The safety and stability of HP-ARA confirmed by several tests. Correlation coefficient of equivalence of HP-ARA and ARA-HS showed 0.992. Conclusion : Based on this result of equivalence between HP-ARA and HS-ARA, HP-ARA can substitute HS-ARA used to make herbal medicines (herbal decoction, pills and powder).