• Title/Summary/Keyword: Pharmaceutical Product

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Pharmaceutical Product Liability and the Burden of Proof (혈액제제 제조물책임 소송과 증명책임 -대법원 2011. 9. 29. 선고 2008다16776 판결과 관련하여-)

  • Moon, Hyeon-Ho
    • The Korean Society of Law and Medicine
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    • v.12 no.2
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    • pp.65-117
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    • 2011
  • This article analyzes the case (2008Da16776) which has the issue how patients have to prove causal relationship when patients claim against pharmaceutical companies alleging that patients were infected with virus due to contaminated blood products. The Supreme court held that: (1) if patients prove that they didn't have symptoms suggesting virus infection before administration of blood products, the virus infection had been confirmed after administration of blood products, and there were significant potential of contamination of the blood products with the virus, the defect in blood products or the negligence of pharmaceutical company in making blood products shall be presumed to cause the infection of the victim. (2) The pharmaceutical companies could reverse the presumption by proving the blood products were not contaminated, but the fact that the victims were treated with the blood products manufactured by other companies or had received blood transfusions is not enough to reverse the presumption. The case is the first decision whether the burden of proof about causal relationship could be reduced in pharmaceutical product liability lawsuit. Hereafter pharmaceutical product liability cases, it would be necessary to reduce the burden of proof about causal relationship in order to make substantive equality between patients and pharmaceutical companies.

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Chinoketides A and B, Two New Antimicrobial Polyketides from the Endophytes of Distylium chinense with the "Black-Box" Co-culture Method

  • Lv, Meng-Meng;Tan, Ming-Hui;Lu, Li-Wen;Zhang, Rong-Hua;Guo, Zhi-Yong;Liu, Cheng-Xiong;Yang, Jin;Zou, Kun;Proksch, Peter
    • Natural Product Sciences
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    • v.24 no.3
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    • pp.159-163
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    • 2018
  • Two new polyketides, chinoketides A and B (1 - 2) with a known compound xylarphthalide A (3), were isolated from the solid medium of the endophytes from the leaves of the relic plant Distylium chinense with the "black-box" co-culture method, and the structures of two new compounds were elucidated by NMR, MS and CD spectra. And the absolute configurations of chinoketides A (1) and B (2) were determined as 2R,3R,8S and 5R,6S by calculating their ECD spectra to compare with the experimental CD spectra. Finally, the antimicrobial activities were evaluated to Erwinia carotovora sub sp. Carotovora (Jones) Bersey et al, and the results showed that compounds 1 - 3 displayed the antimicrobial activities with MIC value at 20.5, 30.4 and $10.2{\mu}g/mL$.

Oriental medicine mangifera indica

  • Rai, Sujay;Basak, Souvik;Mukherjee, Kakali;Saha, BP;Mukherjee, Pulok K
    • Advances in Traditional Medicine
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    • v.7 no.1
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    • pp.1-10
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    • 2007
  • Mangifera indica Linn. (MI) (Family: Anacardiaceae) is commonly known worldwide as mango and ‘Aam’ in India. MI shares an important place in treatment of several diseases in various ancient system of medicine like Ayurveda and other Indian System of Medicine and some other Traditional Medicines world wide. Almost all the parts of MI have been used in oriental medicine, so in this review attempt has being made to review the history, traditional uses, phytoconstituents and therapeutic potentials of mango.

Antitumor effect of Careya arborea against Ehrlich ascites carcinoma with reference to lipid peroxidation and enzymatic and non enzymatic antioxidant system in Swiss albino mice

  • Kumar, R Sambath;Sivakumar, T;Senthil, V;Murthy, N Venkateswara;Balasubramaniam, V;Sabi, R Kanaga;Sundram, R. Shanmuga;Perumal, P;Mazumder, U K;Gupta, M
    • Advances in Traditional Medicine
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    • v.8 no.2
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    • pp.154-163
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    • 2008
  • The methanol extract of stem barks of Careya arborea Roxb. (MECA) (Family- Myrtaceae) was evaluated for antitumor activity and antioxidant status against Ehrlich's Ascites Carcinoma (EAC) bearing Swiss albino mice. After 24 h of tumor inoculation the MECA was administered at the doses of 50, 100 and 200 mg/kg body weight/mice/day for 14 days. After the last dose and 18 h fasting mice were sacrificed. The effect of MECA on the growth of transplantable murine tumor, life span of EAC bearing hosts, hematological profiles, serum and liver biochemical parameters were estimated. The MECA showed significant (P < 0.01) decrease in ascites volume, packed cell volume and viable cell count and prolonged the life span of EAC tumor bearing mice. Hematological profiles reverted to more or less normal levels in extract treated mice. The MECA also produced protective effect by decreasing the activity of serum enzymes, bilirubin and increase the protein and uric acid levels. MECA significantly (P < 0.05) decreased the levels of lipid peroxidation, while significantly (P < 0.05) increased the levels of glutathione content, vitamin C, vitamin E, superoxide dismutase and catalase CAT. The results indicate that MECA exhibited significant antitumor and antioxidant activity in EAC bearing mice.

Brine shrimp lethality and cytotoxicity assay of Araucaria bidwillii Hook in human carcinoma cell lines

  • Ahamed, KFH Nazeer;Kumar, V;Manikandan, L;Wahile, Atul M;Mukherjee, Kakali;Saha, BP;Mukherjee, Pulok K
    • Advances in Traditional Medicine
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    • v.5 no.1
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    • pp.21-28
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    • 2005
  • The leaf extracts of Araucaria bidwillii Hook. (Araucariaceae) were evaluated for their cytotoxic effect in various human cancer cell lines. Preliminary investigation by brine shrimp lethality assay indicated that $LC_{50}$ value of various successive extracts were found to be less than $1000\;{\mu}g/ml$, where the ethyl acetate extract showed maximum activity of less than $100\;{\mu}g/ml$. Further cytotoxic evaluation of various leaf extracts of Araucaria bidwilli Hook was carried out in four different human cancer cell lines-acute myeloblastic leukemia (HL-60), chronic myelogenic leukemia (K-562), breast adenocarcinoma (MCF-7) and cervical epithelial carcinoma (HeLa). Cytotoxicity was assessed by trypan blue dye exclusion method and 3-(4,5-dimethyl thiazole-2yl)-2,5-diphenyl tetrazolium bromide (MTT) reduction assay. From the present investigation it was found that the ethyl acetate and methanol extract of Araucaria bidwilli Hook was found to be more effective in leukemic cell lines and was less effective in MCF-7 and HeLa. The $IC_{50}$ value of the ethyl acetate extract in leukemic cell lines was found to be $28.18\;and\;34.64\;{\mu}g/ml$ and methanol extract was found to be $33.11\;&\;39.81\;{\mu}g/ml$. It can be concluded that various extract from the leaves of Araucaria bidwillii Hook. posses cytotoxic activity tested in brine shrimps and various human carcinoma cell lines.

Development of Process Analytical Technology (PAT) for Total Quality Innovation on Pharmaceutical Processes (의약품 제조공정에서의 전사적 품질혁신을 위한 공정분석기술 개발)

  • Shin, Sang-Mun;Park, Kyung-Jin;Choi, Yong-Sun;Lee, Sang-Kil;Choi, Guang-Jin;Kwon, Byung-Soo;Cho, Byung-Rae
    • Journal of Pharmaceutical Investigation
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    • v.37 no.6
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    • pp.329-338
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    • 2007
  • The quality assurance issue of drug products is more important than the general product because it is highly related to the human health and life. In this reason, the regulatory guide lines have continuously been intensified all around the world. In order to achieve effective quality assurance and real-time product release (RTPR) of drug products, process analytical technology (PAT), which can analyze and control a manufacturing process, has been proposed from the United States. With the PAT process, we can obtain significant process features of materials, quality characteristics and product capabilities from a raw material to the final product in the real-time procedure. PAT can also be utilized to process validation using information system that can analyze the risk of drug products through out an entire product life-cycle. In this paper, we first offered a new concept for the off-line process design methods to prepare the improved quality assurance restrictions and a real-time control method by establishing an information system. We also introduced an automatic inspection system by obtaining surrogate variables based on drug product formulations. Finally, we proposed an advanced PAT concept using validation and feedback principles through out the entire life-cycle of drug product manufacturing processes.

Chitosan-Based Film of Tyrothricin for Enhanced Antimicrobial Activity against Common Skin Pathogens Including Staphylococcus aureus

  • Han, Sang Duk;Sung, Hyun Jung;Lee, Ga Hyeon;Jun, Joon-Ho;Son, Miwon;Kang, Myung Joo
    • Journal of Microbiology and Biotechnology
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    • v.26 no.5
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    • pp.953-958
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    • 2016
  • Chitosan-based film-forming gel is regarded as a promising vehicle for topical delivery of antimicrobial agents to skin wounds, since it protects from microbial infection and the cationic polymer itself possesses antibacterial activity. In this study, possible synergistic interaction against common skin pathogens between the cationic polymer and tyrothricin (TRC), a cyclic polypeptide antibiotic, was investigated, by determining the concentration to inhibit 90% of bacterial isolates (MIC). The addition of the polysaccharide to TRC dramatically reduced the MIC values of TRC by 1/33 and 1/4 against both methicillin-resistant and methicillin-susceptible Staphylococcus aureus, respectively. The synergism of TRC and chitosan combination against both strains was demonstrated by the checkerboard method, with a fractional inhibitory concentration index below 0.5. Moreover, co-treatment of TRC and chitosan exhibited antibacterial activity against Pseudomonas aeruginosa, due to the antibacterial activity of chitosan, whereas TRC itself did not inhibit the gram-negative bacterial growth. These findings suggested that the use of chitosan-based film for topical delivery of TRC could be an alternative to improve TRC antimicrobial activity against strains that are abundant in skin wounds.

Therapeutic potentials and untoward effects of Piper betle and its quid

  • Rai, Sujay;Mal, Mainak;Wahile, Atul;Mukherjee, Pulok K.
    • Advances in Traditional Medicine
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    • v.5 no.4
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    • pp.272-282
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    • 2005
  • Piper betle Linn. (PB), which belongs to the family Piperaceae, is used traditionally in many Asian countries for treatment of a variety of aliments. It has also been used in Ayurveda and Unani systems of medicine. PB leaves are also used as a masticatory in the form of quid. The basic preparation of PB leaves for chewing purposes (PB quid) is known as Paan in India. It is recommended in ancient scripture of Ayurveda and is closely associated with Indian culture. PB is reported to have several therapeutic potentials as well as to produce some untoward effects. The review deals with phytoconstituents present, therapeutic potentials and untoward effects of PB.

Phytochemical and therapeutic potentials of Morinda tinctoria Roxb. (Indian mulberry)

  • Sahoo, Atish K;Narayanan, Nisha;Kumar, N Satheesh;Rajan, S;Mukherjee, Pulok K
    • Advances in Traditional Medicine
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    • v.9 no.2
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    • pp.101-105
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    • 2009
  • Morinda tinctoria Roxb. (Family: Rubiaceae) is commonly known as Indian mulberry or Aal in India. This plant is very well known for its therapeutic benefit in Indian systems of medicine including Ayurveda and Siddha and in other forms of traditional Medicine worldwide for the treatment of several ailments. Almost all parts of this plant have been explored for its medicinal uses. Several reports on the phytochemical and therapeutic benefits of this plant have been reported. In this article an attempt has been made to review the traditional uses, phytochemical profiles and therapeutic potentials of Indian mulberry.