• 보건의료산업학회지
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• 제13권3호
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• pp.105-114
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• 2019

Objectives: This study aimed to provide a comprehensive analysis of the relationship between the service quality of the Korea Health Industry Development Institute (KHIDI), along with the utilization of and customer satisfaction with its export supporting program, and the export performance of Korean pharmaceutical companies. Methods: An online and offline survey was conducted on Korean pharmaceutical companies that have used the export supporting program provided by KHIDI. Data on the service quality of KHIDI, utilization of and customer satisfaction with the export supporting program, and company export performance were collected via survey. Results: Results indicated that systemizing and reliability service factors of the export supporting program have a significant impact on customer satisfaction, and customer satisfaction has a significant impact on utilization of the export supporting program. Furthermore, customer satisfaction and utilization of the program have a significant impact on company expectations regarding future export performance. Conclusions: As a result, service quality, utilization, and customer satisfaction were found to affect Korean pharmaceutical company's expectations regarding their future export performance. The results of this study can significantly impact the development of export supporting programs.

• Journal of Pharmaceutical Investigation
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• 제25권3호spc1호
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• pp.37-42
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• 1995

• 한국응용약물학회:학술대회논문집
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• 한국응용약물학회 2002년도 창립10주년기념 및 국립독성연구원 의약품동등성평가부서 신설기념 국재학술대회:생물학적 동등성과 의약품 개발 전략을 위한 국제심포지움
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• pp.183-190
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• 2002

• 의료법학
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• 제12권2호
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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.

• 대한본초학회지
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• 제23권2호
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• pp.9-17
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• 2008

Objectives : The purpose of this report was to provide the information packaging of herbal medicines by analyzing papers. We investigated the packaging materials, packaging methods and expiration date of herbal medicines by analyzing papers of the Korea, Japan and China. Methods : We survey herbal medicine-related law and crude drug monograph of compendium in each three country, we purchased herbal medicine of the Korea, Japan and China in the market and verify the expressed-item in packing paper. In case of Japan, we examine packaging materials, packaging methods, and expiration date of herbal medicine in pharmaceutical company. Results : The pharmaceutical company in japan used the methods of nitrogen gas pouring, vacuum packing for the herbal medicine packaging. The expiration date of the herbal products in Japan is generally 3 to 5 year after packaging. And packaging materials were aluminium and polyethylene. In Korea, pharmaceutical company used airtight packing for the herbal medicine packaging and expiration date of the herbal product were generally 3 year after packaging. Packaging materials were polyethylene, nylon or polyethylene-nylon mixed materials. In China, pharmaceutical company also used airtight packing for the herbal medicine packaging, and the expiration date were generally 5 year after packaging. Packaging materials were polyethylene, wrapping paper-used parcel or tea leaves filter paper. Conclusion : This results can present the basic data for expiration date and preservation methods of the herbal roots in Korea.

• Journal of Microbiology and Biotechnology
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• 제28권7호
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• pp.1199-1208
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• 2018

Osteoarthritis is a disease that affects the articular cartilage and osseous tissue, and can be worsened by aging, overweight status, and post-traumatic arthritis. The present study aimed to evaluate the effect of ID-CBT5101 (tyndallized Clostridium butyricum) on bone metabolism and the inflammatory response in a monosodium iodoacetate-induced rat model of osteoarthritis. ID-CBT5101 was administered orally at doses of $10^8$ or $10^{10}CFU/day$ for 2 weeks before direct injection of monosodium iodoacetate ($3mg/50{\mu}l$ of 0.9% saline) into the intra-articular space of the rats' right knees. The rats subsequently received the same doses of oral ID-CBT5101 for another 4 weeks. We evaluated the treatment effects based on serum biomarkers, mRNA expression, morphological and histopathological analyses of the knee joints, and weight-bearing distribution analysis. Compared with those in control rats, the ID-CBT5101 treatments significantly reduced the serum concentration of inflammation and bone metabolism markers (i.e., COX-2, IL-6, $LTB_4$, and COMP), and significantly increased the concentration of $IFN-{\gamma}$ and glycosaminoglycans. In addition, the ID-CBT5101 treatments inhibited the mRNA expression of matrix metalloproteinases and tissue inhibitors of metalloproteinases (i.e., MMP-2, MMP-3, MMP-9, MMP-13, TIMP-1, and TIMP-2). Furthermore, the ID-CBT5101 treatments effectively preserved the knee cartilage and synovial membrane, and significantly decreased the amount of fibrous tissue. Moreover, compared with that of the negative control group, the ID-CBT5101 treatments increased the weight-bearing distribution by ${\geq}20%$. The results indicate that ID-CBT5101 prevented and alleviated osteoarthritis symptoms. Thus, ID-CBT5101 may be a novel therapeutic option for the management of osteoarthritis.

• 한국환경과학회지
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• 제19권2호
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• pp.209-215
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• 2010

This study is an endeavor to evaluate the risk assessment of hazardous(aflatoxin $B_1$) in medicines from oriental medical prescription which are circulated much recently. For that, twelve globular and granule types, seven liquid types of herbal medicine were bought to compare and analyze the content of aflatoxin aflatoxin B_1), which are harmful to human body. Woo Hwang Cheong Sim Hwan of Aflatoxin $B_1$ concentration lower than the standard accepted by all the products have been detected, B company(tradition) is the concentration of $1.24\;{\mu}g/kg$, C company $1.04\;{\mu}g/kg$, A company(tradition) and B company did not detect. And the general pill of aflatoxin B1 concentration lower than the standard accepted by all the products have been detected, S-1 is the concentration of $1.8\;{\mu}g/kg$, S-2 of $1.04\;{\mu}g/kg$, S-3 of $0.88\;{\mu}g/kg$, S-4 of $9.32\l\;{\mu}g/kg$, S-6 of $7.8\;{\mu}g/kg$, S-5 did not detect. All the products eundan allowed in the concentration of aflatoxin $B_1$ levels were lower than detection, D company of $0.96\;{\mu}g/kg$, E company concentration was not detected. The liquid product of aflatoxin $B_1$ concentration was found liwer than the standard accepted by all the product, L-3 concentration of $0.8\;{\mu}g/kg$, K-4 was detected in the $1.16\;{\mu}g/kg$, L-1 and L-2 is not detected, L-5 concentration of $15\;{\mu}g/kg$, L-7 is detected as $1.08\;{\mu}g/kg$ and, L-6 was not detected.

• 한국산업정보학회논문지
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• 제29권2호
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• pp.133-151
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• 2024

본 연구는 126년간 제약업을 이어온 동화약품의 핵심가치를 분석하고 꾸준히 경쟁우위를 가질 수 있었던 핵심역량을 살펴보는 것을 목적으로 한다. VRIO Framework을 적용했을 때 126년간 액상형 소화제 시장에서 1위를 지키고 있는 동화약품의 '활명수'를 비롯한 다양한 일반의약품은 '지속적 경쟁우위'를 발생시키는 강력한 자원(Value)이다. 동화정신을 바탕으로 지켜온 원칙경영과 오랜 시간 굳건히 지켜온 믿음, 신뢰 그리고 기업가 정신은 희소성(Rarity)을 가진다. 기네스북 4관왕을 비롯한 다수의 신약 특허를 보유하고 있으며, '한국산업 브랜드파워' 소화제 부문 19년 연속 1위를 차지하며 '골든 브랜드'에 선정되었을 뿐 아니라 다수의 제품이 소비자에게 인지도가 매우 높은 점 등은 모방불가능성(Imitability)이 높다고 할 수 있다. 마지막으로 명확한 직급체계, 공정한 인사고가, 다양한 교육훈련, 높은 수준의 직원복지와 연봉 등 자원을 효율적으로 활용할 수 있도록 조직(Organization)되어 있다. 본 연구는 동화약품의 경영적 측면에서 핵심가치를 체계적으로 분석하였으며 더불어 장수기업으로 나아가기 위한 방향을 제시하였다. 이러한 연구결과는 장기적인 경영전략 수립 시 유용한 시사점을 제공할 것으로 기대한다.

• 의료법학
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• 제23권4호
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• pp.3-28
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• 2022

공단과 제약사 간 협상은 제도 도입 이후 지속적으로 범위와 대상을 확대하여 왔고, 최근에는 품질관리에 관한 사항 등이 협상 대상으로 추가되었다. 그에 따라 복지부의 상한금액 고시가 아닌 공단과의 협상만으로도 제약사들의 법익이 침해될 우려가 제기되었고, 그로 인해 협상의 법적 성격과 법익 침해에 대한 구제방법 등의 검토 필요성이 대두되었다. 복지부장관이 공단 이사장에 대한 협상'명령'을 내리면, 공단이 제약사에 이를 '통보'하여 '협상'이 진행된다. '명령'은 행정권 내부의 행위로서 항고소송의 대상이 되는 처분성이 부인된다. 이에 반해 '통보' 내지 '협상'은 제약사를 상대방 당사자로 하는 행위로서, 협상 결렬에 대한 불이익이 존재한다면 그 자체를 '처분'으로 볼 여지도 있을 것이다. 협상은 '대상(보험급여목록에 등재되어 있는지 여부)'과 '목적(협상대상이 가격인지 조건 부여인지)'에 따라 4개 유형으로 세분할 수 있다. 조건 부여에 관한 협상은 협약을 통해 부담(부관)을 설정하도록 하는 합의가 된다. 신규 등재 또는 가격 인상 약제 협상의 경우에는 수익적·재량적 행정행위에 부담을 부착하는 경우로서 조건 부여 협상이 적법할 것이지만, 기등재 약제의 가격 조정은 대부분 가격을 인하하는 침익적 처분으로서 협상을 통해 부담을 부착할 경우 위법할 여지를 배제하기 어렵다. 따라서 부담의 설정이 필요하다면 인센티브 등의 부여를 통해 협상에 따른 고시가 수익적·재량적 행정행위가 될 수 있는 길을 열어놓을 필요가 있을 것이다.

• KSBB Journal
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• 제28권1호
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• pp.54-59
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• 2013

Three isolates, E. faecium P1, P2 and P3, from intestinal drugs of three phamaceutical companies, four clinical vancomycin resistant isolates, E. faecium V1, V2, V3 and E. faecalis V4, and three isolates, E. faecalis DW01, DW07 and DW14, from infant feces were tested for the presence of virulence genes, ace, agg, esp, efaA, gelE, sprE, vanA and vanB as well as fsrABC, regulatory genes of gelE and sprE, cylMBA, cytolysin activation genes and cpd, cob and ccf, pheromone genes by PCR and for their phenotype activities such as protease, biofilm formation, cell clumping and hemolysis. The genes encoding cell surface adherence proteins, ace, agg, esp and efaA, were predominantly amplified from the vancomycin resistant strain V4 and the fecal isolates DW01, DW07 and DW14. Both protease and biofilm formation activity were detected only from E. faecalis V4 from which the PCR products of gelE and spreE as well as fsrABC were amplified. The pheromone genes were amplified from the V4, DW01, DW07 and DW14 strains and these strains showed clumping activity. Biofilm formation was observed from the strains DW01, DW07 and DW14, all of which produced PCR products of pheromone, and V4 as well. Whole cytolysin regulator genes were amplified from DW01, DW07 and DW14 and ${\beta}$-hemolysis activity was detected from these strains. Any virulence genes or activities except the pheomone gene ccf were not detected from the pharmaceutical isolates, E. faecium P1, P2 and P3.