• 혜화의학회지
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• 제10권2호
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• pp.41-71
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• 2002

The purpose of this paper is to infer the effects on the separation of pharmacy and clinic in the oriental medicine, the unification of the medical system and the medical and pharmaceutical system, etc. from the conflict between the oriental medicine doctors and the pharmacists in 1990s. The results are as follows. 1. The oriental medicine doctors, the pharmacists and a private organization(Citizen's Coalition for Economic Justice) found the solution in the conflict nongovernmently as the government failure. 2. The conflict brought about directly the separation of pharmacy and clinic in the western medicine but the opposite effect in the oriental medicine. 3. The conflict brought about the continuance of the dual medical system. 4. In the part of the medicine, citizen's organizations stated to play their part in the dispute. This is a positive side in the conflict. 5. The conflict contributed to democratization in the medical market and the medical world.

• 약학회지
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• 제57권6호
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• pp.412-419
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• 2013

Drug discovery and development processes are time consuming and costly endeavors. It has been reported that on average it takes 10 to 15 years and costs more than $ 1billion to bring a molecule from discovery to market. Compounds fail for various reasons but one of the significant reasons that accounts for failures in clinical trials is poor prediction/understanding of pharmacokinetics and drug metabolism in human. In an effort to improve the number of compounds that exhibit optimal absorption, distribution, metabolism, elimination (ADME), and pharmacokinetic properties in human, drug metabolism, pharmacokinetic scientists have been continually developing new technologies and compound screening strategies. Over the last few years, accelerator mass spectrometry (AMS) and its applications to preclinical/clinical pharmacokinetics and ADME studies have significantly increased, particularly for new chemical/biological entities that are difficult to support with conventional radiolabel studies. In this review, the application of AMS for micro-dosing, micro-tracer absolute bioavailability, mass balance and metabolite profiling studies will be discussed.

• The Journal of Asian Finance, Economics and Business
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• 제8권4호
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• pp.735-740
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• 2021

The purpose of this study is to assess how accounting conservatism is practiced in the Jordanian pharmaceuticals and medical industry. It assesses the association between accounting conservatism and intellectual capital (IC) in this industry. This study measures IC performance using the market price per share less book value. Accounting conservatism is measured using the book-to-price ratio, and the data was collected from company annual reports and the Amman Stock Exchange (ASE) website. The data was collected for the period of six years (2014 to 2019). The sample was made up of four companies in the industry listed in the ASE. The data was analyzed using the SPSS program though the ordinary least squares regression model to assess how accounting conservatism is associated with IC. The findings indicate a negative association with companies having higher IC performance and reporting lower accounting conservatism. IC is applied more in these companies, although it might be lower than in other companies in other sectors. This study provides empirical evidence on how IC is applied in the industry and how it might be negatively associated with accounting conservatism. Findings indicate the need for more effective policies to promote recognition of intangible assets in the sector.

• 한국해양바이오학회지
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• 제13권1호
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• pp.20-27
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• 2021

Ironically, marine bioresource production in Chungnam Province is the second-largest in the country. The province's marine bioresource production puts its lack of a marine bioindustry in the spotlight despite the region's favorable conditions to produce representative value-added and (ultra) high value-added products such as neutraceutical and/or pharmaceutical function. This juxtaposition is to be expected, as there are no institutions for training professionals in the field of marine biology or in the fisheries industry in the West Sea area. The unique features of the region require individuals with specialized training who have been educated in accordance with regional development and the specificity of the region. Recently, however, a plan has been initiated at the national level to foster the growth of the marine biology industry in the Chungnam Province on Korea's west coast. This plan includes increasing funds to the marine biology market to 1.2 trillion by 2030. If the Chungnam region wants to successfully revitalize the marine biology industry and put the increased funds to efficient use, it must first establish various research and (business) development (R&(B)D) plans regarding local marine biology infrastructures and marine biology programs at local universities. It must also focus on training specialists to protect, maintain, and develop the region's marine bio-resources to increase the growth of the region's bioindustry.

• Journal of Pharmaceutical Investigation
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• 제39권3호
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• pp.207-216
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• 2009

Fluconazole is used as an orally administrated antifungal drug for the treatment of tinea corporis, candidiasis including skin mycotic pneumonia infections. The dosage of fluconazole varies with indication ranging from 50 mg/day to 400 mg/day. The fluconazole capsule 50 mg (3 capsules daily) is already available in Korean market. To improve the patient compliance, a fluconazole tablet 150 mg (once a day administration) was developed recently. The purpose of this study was to evaluate the bioequivalence of three doses of fluconazole capsule 50 mg (Diflucan 50 mg, Pfizer Korea Inc., as a reference drug) and a single dose of fluconazole tablet 150 mg (Plunazol 150 mg, Daewoong Pharm. Co., Korea) according to the guidelines of the Korea Food and Drug Administration (KFDA). The bioequivalence for three capsules of Diflucan 50 mg and a single tablet of Plunazol 150 mg was investigated in twenty-four healthy male volunteers under a randomized 2${\times}$2 crossover trial design. The average age of twenty-four volunteers was 24.78${\pm}$3.27 year-old, average height was 175.56${\pm}$5.45 cm and average weight was 67.24${\pm}$6.86 kg. After three capsules of Diflucan 50 mg or a single tablet of Plunazol 150 mg were orally administered, blood was taken at predetermined time intervals and the plasma concentrations of fluconazole in plasma were determined using LC-MS-MS. The 90% confidence intervals for the main parameters of statistical results after logarithmic transformation were AUCt 0.9272-1.0084 and Cmax 0.8423-0.9544 respectively, which are in the range of log 0.8 to log 1.25 and the statistical results of additional parameters (AUClast, t1/2 and MRT) were also in the 90% confidence interval that is in the range of log 0.8 to log 1.25. Therefore, the results of this study confirm the bioequivalence of three capsules of Diflucan 50 mg to one tablet of Plunazol 150 mg.

• 한국토양비료학회지
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• 제24권3호
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• pp.206-209
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• 1991

농가에서 3년간 재배중인 작약(芍藥), 목단(牧丹), 모단(牡丹)을 접붙인 작약(芍藥)(목단(牧丹)/작약(芍藥))근(根)을 수집해서 외형적(外形的) 생육특성(生育特性)과 유효성분(有效成分)을 분석한 결과 다음과 같은 결론(結論)을 얻었다. 1. 목단(牧丹)/작약(芍藥)을 접목(接木)한 지하부(地下部)의 외형적 생육상태(生育狀態)는 작약(芍藥)의 특성과 같았으나, 달관(達觀) 조사(調査)에 의하면 목단(牧丹)/작약접목근(芍藥接木根)이 작약(芍藥)에 비해 2~3배의 증수량(增收量)을 나타냈다. 2. 목단속(牧丹屬)(Paeonia linne) 식물의 주요(主要) 유효성분(有效成分)인 Paeoniflorin은 목단(牧丹)/작약근(芍藥根)이 0.98%로 작약(芍藥) 0.78%, 목단(牧丹) 0.46%보다 0.2%에서 0.5%까지 각각 높게 나타났으며, 목단(牧丹)에 다량 함유된 Paeonol은 목단접목(牧丹接木)으로 인해 목단(牧丹)/작약(芍藥) 접목근(接木根)에서 함량(含量)이 증가되지는 않았다. 3. 결과적(結果的)으로 수량(收量)과 유효성분(有效成分) 측면을 종합비교(綜合比較)해 볼 때, 작약(芍藥)의 뿌리를 대목(臺木)으로 하여 모단경(牡丹莖)을 접수(接穗)로 접목(接木)함으로서 근생육(根生育)이 괄목할만하게 증대되었고, 약효성분(藥效成分)은 작약(芍藥) 고유의 함량비(含量比)를 유지하는 것으로 추정되어 향후 체계적인 연구의 필요성을 제시해 주었다.

• 대한한의학원전학회지
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• 제24권2호
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• pp.23-50
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• 2011

"LeiGongPaoZhiLun" is the first pharmaceutical book, and there are various opinion on when LeiXiao(雷斅), the author lived. From the aspect of several data, it is appropriate most that LeiXiao live in the period of Sui(隋) Dynasty, like SuSong(蘇頌) in the Sung Dynasty said, This book was not made at one time by one person. At the beginning, it was written by LeiXiao and the later generations enlarged to finish. The original of "LeiGongPaoZhiLun" disappeared already but a large amount of this book was quoted to "ZhengLeiBenCao(證類本草)" to be preserved. The contents of "LeiGongPaoZhiLun" are the first professional book about processing of medicinal, in which most of processing of medicinal that is generally used today, is included and some methods are unused. Besides, the regulations of this book are specific, the range is broad, and theoretical frame is established for the first time. This book has abundant contents, in which several processing of medicinal are written. There are 10 methods such as steaming(蒸法), boiling(煮法), baking(炮法), stir-frying(炒法), calcining(煅法), long time boiling(煉法), scorching(燒法), baking after wrapping(煨法), immersing(浸法), washing(洗法), flying(飛法), etc. How to remove some section that is not used for drug, how to separate according to medical use and region to be applied, how to smash, how to cut, how to dry, container for medicine, warning for making a prescription, time to make medicine and amount of medicine, how to distinguish superior and inferior and origin, how to make medicine partially, etc, are contained in this book. The contents of "LeiGongPaoZhiLun" can be mixture of processing of medicinal of medical scientists and taoists. In conclusion, however, the effect by the later medical generations of "LeiGongPaoZhiLun" was not great on processing of medicinal. It stemmed from the difference of processing of medicinal in this very taoistic book that realistic difficulties were disregarded by taoists for training and practical purpose, treatment that is the reason that later medical generations used processing of medicinal. Consequently, there is no great relation between the development of processing of medicinal in the Sung Dynasty and this book. "LeiGongYaoXingFu(雷公藥性賦)" that was abundant in medical market in Ming(明) and Qing(清) period has no relation with "LeiGongPaoZhiLun" is kind of a distribution-purposed book that was mnge in or after Ming Dynasty. However, since a book that is said to be written by 'LiGao(李杲)'PaoZhihis nof a dijust borrowed and focus on a brief summery, it is not desirable for beginners to learn medical knowledge. "LeiGongPaoZhiLun" is the first pharmaceutical book and is a model to show how a science in the history of the herb medicine generated and developed and how such a book is changed and modified to make a change of value.

• 의료법학
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• 제22권4호
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• pp.159-184
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• 2021

첨단재생바이오법의 제정 의의는 본질적으로 '이식'이라는 의료행위인 재생의료를 약사법 규제에서 벗어나 의료기술적 접근으로 환자치료기회를 확대하는 데 있다. 그러나, 법이 시행된 지 1년여가 지난 상황에서 식약처가 승인하는 고위험연구는 1건도 승인되지 않고 있는 등 임상연구가 활성화되지 않고 있다. 그 이유는 환자치료기회 확대를 위한 법률 취지에도 불구하고 법률적 근거가 미흡함에도 임상연구 승인을 위한 자료요건을 의약품 개발과 연결하여 정하고 있어 많은 연구자들이 자료요건을 맞추기가 어려운 실정이다. 법 제정 이전 약사법 체계 내의 세포치료제 임상연구를 위한 제출자료는 품질 및 비임상시험 자료가 상당히 면제되었지만, 첨단재생바이오법이 시행되면서 임상연구 계획 승인신청 시 품질 및 비임상시험자료를 의약품에 준해 요구하고 있다. 이를 바로잡으려면 치료기회 확대를 위한 첨단재생의료 임상연구의 정체성을 고려할 때 의약품 개발과 연결하는 데는 제한점이 있음을 인식하고 첨단재생의료 임상연구의 정체성을 지키고, 한편으로 품목허가 시 임상연구 결과를 활용할 수 있도록 하면서 활용요건을 구체화하여 시장의 힘으로, 임상연구자의 자발적인 동기로 임상연구 승인을 위한 기본요건보다 필요한 자료를 스스로 준비할 수 있도록 해야 한다.

• 대한본초학회지
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• 제27권2호
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• pp.25-29
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• 2012

Objectives : This article reviews a solution preventing the illegal distribution of herbal medicine in common use for food and medicine and risks on public health by conducting safety management of food and medicine. Also, this article would like to contribute to improvement of public health treating diseases in compliance with accurate diagnosis and prescription of Oriental Medicine Doctor("OMD")'s. Methods : An approach in this research can be categorized into two : first, to examine the current administrative situation and problems of herbal medicine in common use for food and medicine based on policy documents of Ministry of Health and Welfare and Korea Food and Drug Adminstration("KFDA") and academic articles of the herbal medicine;second, to find reasonable administrative solutions to solve the problems. Solutions : A solution is to strengthen the management level of herbal medicine in common use for food and medicine by selecting 117 items as target items requiring concentrated management. In case herbal medicine is imported for food, KFDA strengthens the quality management level of herbal medicine by making use of inspection frequency at random, collecting and verifying herbal medicine on the market. However, KFDA decides to maintain current different quality specification system of food and medicine reflecting a civil complaint that quality specification of food and medicine should separately managed according to the purpose of use. Herbal medicine as medicine that is functioned as treating diseases and alleviating symptoms, unlike herbal medicine for food, can cure all kinds of diseases by recovering inner balance of human body, making use of other properties of herbal medicine. Medicine has its own properties. If a doctor uses properties of medicine appropriately, he cures diseases. If a doctor uses herbal medicine inappropriately. he may damage human body. Thus, whether side effects of medicine depend on a doctor who uses herbal medicine. Conclusions : All herbal medicine will be supplied into the market after strict safety control of manufacturers of herbal medicine according to the revised Pharmaceutical Affairs Act, beginning in April, 2012. Thus, people can take safer and more reliable herbal medicine through strengthening safety management of herbal medicine and improving quality and transparency in the distribution system. Herbal medicine should appropriately be prescribed by licensed OMD because herbal medicine is used to treat diseases and alleviate symptoms, unlike herbal medicine for food.

• 지식경영연구
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• 제21권3호
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• pp.105-121
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• 2020

신약 개발과 관련하여 글로벌 판매망이 구축되지 않은 국내 바이오텍에게 가장 필요한 것은 신약의 기술이전과 관련된 의사 결정이다. 각 임상 단계별 성공 확률이 다르고, 어느 임상 단계에서 기술이전 계약을 하느냐에 따라서 총 계약금액과 로열티가 달라지게 된다. 이런 기술이전 계약의 특징과 바이오텍의 취약한 재무 구조 등으로 인하여, 바이오텍이 빅파마에게 기술 이전을 하는 시기를 정하는 것은 매우 중요한 의사 결정 문제가 된다. 이 연구에서는 '신약의 기술이전 최적시기 결정 문제'라는 연구모형을 제시하고, 의사결정트리 방법론으로 결과를 도출하였다. 사례 연구로, first-in-class 신약을 대상으로 FDA 글로벌 임상을 진행하고 있는 국내 바이오텍에 적용해 보았다. 타겟 질환의 시장 크기와 예상 시장 침투율은 알려져 있다고 가정하였을 때, 임상 1상이나 2상 이후에 기술이전을 하는 것이 이익을 최대화할 수 있는 대안임을 알 수 있었다. 본 연구는 제약 분야 문제에 경영과학 방법론을 사용할 수 있는 개념적인 틀을 제시하여 신약 기술이전에 대한 지식 및 연구의 기반이 될 수 있을 것으로 기대된다.