• Title/Summary/Keyword: Pharmaceutical company

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A Study on the Product Liability Case of a Cold Medicine CONTAC 600 in Terms of Civil Law (감기약 콘택600 제조물책임사건에 관한 민사법적 고찰 - 대법원 2008.2.28. 선고 2007다52287 판결 -)

  • Jeon, Byong-Nam
    • The Korean Society of Law and Medicine
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    • v.10 no.1
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    • pp.213-260
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    • 2009
  • While the medical supplies have positive functions such as extending lifespan, recovering health, and preventing diseases, they also cause unexpected tragic consequences due to their side effects, and the magnitude of such damage inevitably increases due to the mechanism of mass production, mass distribution, and mass consumption of those medical supplies. Therefore, needless to say, the optimal way to prevent or reduce such damage is rather through medical supply manufacturers' producing non-defective products, or through the government's controlling production and sales of medical supplies with more aggressive exercise of regulatory authority on medical supply manufacturers, than through a remedy by a legal relief after using medical supplies. In this case, although the victim died due to the defect of the cold medicine, 'CONTAC 600', the drug company's responsibility to cover damages was not recognized because a defect could not be found in the then-manufacturing process. Thus, while pharmaceutical companies are gaining economic profits by producing and selling a medical supplies, if they do not take any remedy measures for the victims of their products' side effects, the victims have to use medical supplies under their own responsibility of taking a risk, and they have to accept the full damage of the potential consequence. Therefore, to remove such absurdity and contradiction, and to practically remedy the victim of medical supplies' side effects, the pharmaceutical side effects remedy project pending in the the Drugs, Cosmetics and Medical Instruments Lawneeds to be actively implemented.

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The Effectiveness of Facilitation Education for Call Quality of Medical Representative in Pharmaceutical Industry (제약회사 영업사원의 면담 품질(Call Quality) 향상을 위한 퍼실리테이션(Facilitation) 교육법의 효과)

  • Im, Hyung Sik;Kang, Shin Kook;Lee, Kwang-Su;Hong, Jin Tae
    • The Korean Journal of Health Service Management
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    • v.13 no.4
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    • pp.215-228
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    • 2019
  • Objectives: The purpose of this study is to figure out that Facilitation education can affect significant improvement in sales staff's understanding of precise pharmacokinetics, benefits, safety, and side effects, etc. and eventually lead to increase in call after taking courses. Methods: Data utilized in this study was collected from 413 sales staffs who completed Facilitation course for 5 months. This study used statistical methodologies, paired t-test, exploratory factor analysis, and logistic regression model in order to identify change in Call and after Facilitation courses. Results: The result shows that there are statistically significant increases in CALL quality after Facilitation courses based on the result of pared t-test. Moreover, Facilitation education is more effective in average time of one-time detail than average number of visits per day and average number of doctors per day from the result of logistic regression. Conclusions: In order for MR in pharmaceutical company to improve CALL quality, the education for precise pharmacokinetics, benefits, safety, and side effects is necessary. In addition, various professional training required for detail, including disease education, Selling Skills education, and literacy education are essential. Therefore, Facilitation education would be desirable choice in terms of pharmaceutical marketing strategy.

The Meaning and the Legislative Suggestion about Data Manipulation of Pharmaceutical Companies in the Aspect of the Medicine Approval System (의약품 품목허가 제도에서 제약기업 자료조작의 의미와 입법 개선 방안-대법원 2008. 11. 13. 선고 2008두8628 판결을 중심으로-)

  • Park, Sungmin;Shin, Youngkee
    • The Korean Society of Law and Medicine
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    • v.22 no.4
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    • pp.59-88
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    • 2021
  • The National Assembly of the Republic of Korea recently enacted laws to fortify sanctions about data manipulation of pharmaceutical companies. The medicine approval system is the result of legislative efforts to prevent accidents that caused damages to patients' life and health. The medicine approval system is based on the trust that the data submitted by pharmaceutical companies is not manipulated. The Supreme Court of Korea clarified that strict standard shoud be required to secure the medicine safety in Supreme Court Decision 2008Du8628 decided November 13, 2008. We agree. This paper suggest legislation to weaken the economic incentives for pharmaceutical companies to choose data manipulation by minimizing the expected profit. In addition to revoking the marketing authorization of the medicine, the 'unfair' profits the pharmaceutical company has earned must be recovered. In addition, in order to increase the possibility to discover data manipulation, it is necessary to strengthen the review capacity and to activate the whistle-blowing.

Studies on Pollen Preparations as a Health Food(I) (건강(健康) 식품(食品)으로서 화분(花粉) 제제(製劑)에 관한 연구(硏究)(제1보)(第1報))

  • Kim, Jung-Woo;Shin, Sang-Chul;Kim, Byong-Kak
    • Korean Journal of Pharmacognosy
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    • v.15 no.3
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    • pp.147-149
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    • 1984
  • To examine pollen preparations which are being sold as a health food, one of these pollen tablets and one of the capsules were selected and investigated by microscopy. It was shown that the pollen coat which can act as a potent allergen was not removed and that the tablets contained other impurities. The results suggest that they are not safe as a food and that they may cause systemic allergy to certain persons. On the contrary, the pollens of the capsule preparation did not have the pollen coat and, therefore, have a less risk of causing allergy.

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Sequence Analysis of NS4 Region of HCV Isolated from Korean Patient

  • Paik, Sang-Hoon;Lee, Young-Ik;Kim, Won-Bae;Yang, Jai-Myung
    • Journal of Microbiology
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    • v.33 no.3
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    • pp.260-266
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    • 1995
  • Hepatitis C virus (HCV) has been considered as a mojor causative agent of post-transfusion related non-A, non-B hepatitis. In this study, the cDNA sequence of NS4 region of HCV (HCV-S) obtained from a Korean patient's plasms was determined. Comparative nucleotide sequence analysis between to type II. 67.2% homology to type III, and 66.4% homology to type IV. The putative amino acid sequence homologies to types I, II, III, and IV were 82.8-84.7%, 92.5-95.1%. 72.5, and 71.1%, respectively. This data strongly suggests that HCV-S should be classified as type II. Significant similarities of hydrophobicity profiles and putative transmembranous domains were found in HCV-S and four major prototypes, indicating that the protein structure is similar in spite of the heterogeneities of intertype homologies at the level of the psrimary nucleotide and amino acid sequences.

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Investigation of gene expression of GX-12, a new DNA vaccine for HIV infection, in reproductive organs in SD rats

  • Kang, Kyung-Koo;Park, Min-Seul;Ahn, Kook-Jun;Baik, Dae-Hyun;Sohn, Yong-Sung;Lee, Dong-Sup;Park, Jae-Hun;Ahn, Byoung-Ok;Kim, Won-Bae
    • Proceedings of the Korean Society of Toxicology Conference
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    • 2002.11b
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    • pp.201-201
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    • 2002
  • GX-12 is a naked DNA vaccine developed by Dong-A pharmaceutical company for the treatment of mv infection. GX-12 consists of four separate plasmids. This study was performed to evaluate the biodistribution and expression of GX-12 mRNA in gonadal tissues, and to investigate the histopathological changes in rats after repeated intramuscular injection.(omitted)

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Studies on the Anti-inflammatory Activity of Caragana chamlagu Roots (골담초근(骨擔草根)의 항염작용(抗炎作用)에 관한 연구)

  • Kwak, Jin-Hwan;Kim, Il-Hyuk
    • Korean Journal of Pharmacognosy
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    • v.5 no.3
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    • pp.179-184
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    • 1974
  • Experiments were carried out to evaluate the anti-inflammatory activity of Caragana chamlagu $L_{AMARCK}$ roots, which was known to be effective as antineuralgic, antirheumatic and antiarthritic, etc. in the folk cures of this country. The ether extract of the root has shown significant effects against the rat paw edema induced by 1% carrageenin and its potency was comparable with acetylsalicylic acid, a anti-inflammatory drug, when given orally in 5% acacia gum suspension. The ethanol and hexane extracts, on the other hand, stimulated the formation of rat paw edema under the same experimentation.

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Effects of Ultraviolet Blood Irradiation in a Type 1 Diabetic Rabbit (제1형 당뇨토끼에서 자외선 혈액 조사 효과)

  • Yang, Yeong-Seok;Kim, Gi-Beum
    • Journal of Biomedical Engineering Research
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    • v.40 no.3
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    • pp.81-96
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    • 2019
  • The purpose of this study is to evaluate the effects of ultraviolet blood irradiation on the blood when a low dose of ultraviolet (UV) C is directly irradiated to the blood in a diabetic rabbit model and to evaluate the effects on treatment for diabetes. This study results indicate that the reduced body weight is increased and blood glucose levels are significantly reduced after the UBI treatment is performed when compared to those prior to the UBI treatment. In addition, $HCO_3{^-}$ levels and blood pH were elevated and lowered, respectively. When the UBI treatment is performed in a diabetic rabbit model, in this result indicate that blood glucose levels are reduced.

Proficiency Test for Pharrnaceutical Companies in Analyzing Drug Products (II) - Analysis of Variance of Factors Influencing Test Results

  • Cho, Jung-Hwan;Choi, Seon-Hee;Sung, Jun-Hyun;Lee, Seung-Kyung;Lee, Hwa-Jung;Choi, Yong-Hoon;Sho, Yoo-Sub;Moon, Byung-Woo
    • Proceedings of the PSK Conference
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    • 2002.10a
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    • pp.396.2-396.2
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    • 2002
  • Analytical results during the proficiency test managed by Kyungin Regional Korea Food & Drug Administration were proposed to be influenced by several factors. Data of several factors were collected along with the test results with ibuprofen and sobrerol formulations. The collected data were the use of internal standard, academic background and career of analytical personnel, production size of the company and location of the participating laboratory. (omitted)

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Acute effects of 2-bromopropane and 1,2-dibromopropane on hepatotoxic and immunotoxic parameters

  • Kim, Nam-Hee;Hyun, Sun-Hee;Kim, Chun-Hwa;Lee, Sang-Kyu;Lee, Dong-Wook;Jeon, Tae-Won;Lee, Jae-Sung;Lee, Eung-Seok;Chae, Whi-Gun
    • Proceedings of the PSK Conference
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    • 2003.04a
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    • pp.188.1-188.1
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    • 2003
  • 2-Bromopropane (2-BP) is a major component of the mixture of SPG-6AR and Solvent 5200 that is a substitute of chlorofluorocarbon. Many female workers exposed to 2-bromopropane in a Korean electronic company were found to have amenorrhea and male workers were diagnosed with oligospermia. In the present studies, immunotoxic effects of 2-BP and an analog, 1,2-dibromopropane (1 ,2-DBP), were investigated in female BALB/c mice. (omitted)

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