• Title/Summary/Keyword: Pharmaceutical Market

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A study on the process and the historical significance of the conflict between the oriental medicine doctors and the pharmacists in Korea (90년대(年代) 한약분쟁(韓藥分爭)의 과정(過程)과 역사적(歷史的) 함의(含意) -한방의약분업(韓方醫藥分業)과 의료일원화(醫療一元化)에 미치는 영향(影響)을 중심(中心)으로-)

  • Shin, Sang-moon;Yoo, Dong-yeul
    • Journal of Haehwa Medicine
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    • v.10 no.2
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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.

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Trends of Innovative Clinical Drug Development using AMS (Accelerator Mass Spectrometry) and $^{14}C$-micro Tracer (가속질량분석기(Accelerator mass spectrometry, AMS)와 극미량 $^{14}C$-동위원소를 이용한 혁신적 임상시험개발동향)

  • Cho, Kyung Hee;Lee, Hee Joo;Choie, Hyung Sik;Lee, Kyoung Ryul;Dueker, Stephen R.;Shin, Young G.
    • YAKHAK HOEJI
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    • v.57 no.6
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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 Relationship Between Intellectual Capital and Accounting Conservatism: A Case Study in Jordan

  • OWAIS, Walid Omar
    • The Journal of Asian Finance, Economics and Business
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    • v.8 no.4
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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.

Marinebio Industry review and Strategy Analysis of Chungnam Province (충남 해양바이오산업 현황과 전략 분석)

  • Jung, Myung-Hwa;Cha, Seon-Heui
    • Journal of Marine Bioscience and Biotechnology
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    • v.13 no.1
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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.

The Bioequivalence of Plunazol Tablet (Fluconazole 150 mg) to Three capsules of Diflucan 50 mg (디푸루칸 캡슐 50 mg (3 캡슐, 플루코나졸 150mg)에 대한 푸루나졸 정 150mg의 생물학적 동등성)

  • Chang, Hee-Chul;Lee, Min-Suk;Ryu, Chong-Hyon;Lyu, Seung-Hyo;Cho, Sang-Heon;Choi, Yeon-Jin;Hwang, Ae-Kyung;Kim, Yun-Ah;Park, Si-Hyun;Yoon, Ji-Won;Bae, Kyun-Seop
    • Journal of Pharmaceutical Investigation
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    • v.39 no.3
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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.

Effect of Graft of Paeonia moutan into Paeonia albiflora on Pharmaceutical Components (모단(牡丹)(Paeonia moutan Sim) 접목(接木)이 작약(芍藥)(Paeonia albiflora Palls) 근(根)의 유효성분(有效成分)에 미치는 영향(影響))

  • Chang, Ki Woon;Kim, Phil Joo;Chung, Ha Il;Moon, Chang Sik;Ahn, Byeong Chang
    • Korean Journal of Soil Science and Fertilizer
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    • v.24 no.3
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    • pp.206-209
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    • 1991
  • This paper was intented to find out the effect of graft of Paeonia moutan scion into Paeonia albiflora stock on the yield and the pharmaceutical components of the root-Paeoniflorin, Albiflorin, Oxypaeoniflorin and Paeonol. The roots of Paeonia albiflora(PA), Paeonia moutan(PM) and Paeonia albiflora grafted in Paeonia moutan (M/A), were collected after being cultivated for three years in Yoenki, Chungnam, Korea. The following results were obtained ; 1. The growth characteristics of the underground part of M/A were similar to those of PA. 2. The yield of M/A was 3-5 times as that of PA in appearance. 3. The amount of Paeoniflorin in M/A was 0.2-0.5% higher than that in PA. The content of paeonol in M/A was not increased by grafting of paeonia moutan with high concentration of paeonol.

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A Study On "LeiGongPaoZhiLun(雷公炮炙論)" - Centering Of Processing Of Medicinal - ("뇌공포자론(雷公炮炙論)"에 관한 연구 - 포제(炮制)를 중심으로 -)

  • Ha, Hong-Ki;Kim, Ki-Wook;Park, Hyun-Kook
    • Journal of Korean Medical classics
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    • v.24 no.2
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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.

Study on Significance and limitations of the Enactment of the Advanced Regenerative Bio Act (첨단재생바이오법의 제정 의의와 제한점)

  • Sohn, Seong Goo;Kwon, Kyeng Hee
    • The Korean Society of Law and Medicine
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    • v.22 no.4
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    • pp.159-184
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    • 2021
  • The significance of the enactment of the 「Act On The Safety Of And Support For Advanced Regenerative Medicine And Advanced Biological Products」 is to break away from the regulation of the Pharmaceutical Affairs Act and expand patient treatment opportunities through a medical technology approach to regenerative medicine, which is essentially a medical practice called 'transplantation'. However, more than a year after the law was enacted, clinical study has not been activated, with not a single high-risk study approved by the Ministry of Food and Drug Safety being approved. The reason is that despite the legal purpose of expanding patient treatment opportunities, the data requirements for clinical study approval are set in connection with drug development despite the insufficient legal basis, making it difficult for many researchers to meet the data requirements. Prior to the enactment of the Act, submitted data for clinical study on cell therapy products within the Pharmaceutical Affairs Act were cosiderably exempted from quality and non-clinical test data, but with the enforcement of the Advanced Regenerative Bio Act, quality and non-clinical test data are required in accordance with pharmaceuticals when applying for approval of a clinical study plan. To rectify this, when considering the identity of clinical study on advanced regenerative medicine to expand treatment opportunities, recognize that there are limitations in connection with drug development. And it is necessary to preserve the identity of clinical study on advanced regenerative medicine, and on the other hand, in the case of drug product approval, clinical study results should be utilized while specifying usage requirements. Therefore, with the power of the market and the voluntary motive of the clinical researcher, it is necessary to prepare the necessary data by themselves rather than the basic requirements for clinical study approval.

A Research on Management System of Herbal Medicine in Common Use for Food and Medicine (식약공용 한약재의 관리 방안에 관한 연구)

  • Kweon, Kee-Tae
    • The Korea Journal of Herbology
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    • v.27 no.2
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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.

Determine Optimal Timing for Out-Licensing of New Drugs in the Aspect of Biotech (신약의 기술이전 최적시기 결정 문제 - 바이오텍의 측면에서)

  • Na, Byungsoo;Kim, Jaeyoung
    • Knowledge Management Research
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    • v.21 no.3
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    • pp.105-121
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    • 2020
  • With regard to the development of new drugs, what is most important for a Korean Biotech, where no global sales network has been established, is decision-making related to out-licensing of new drugs. The probability of success for each clinical phase is different, and the licensing amount and its royalty vary depending on which clinical phase the licensing contract is made. Due to the nature of such a licensing contract and Biotech's weak financial status, it is a very important decision-making issue for a Biotech to determine when to license out to a Big Pharma. This study defined a model called 'optimal timing for out-licensing of new drugs' and the results were derived from the decision tree analysis. As a case study, we applied to a Biotech in Korea, which is conducting FDA global clinical trials for a first-in-class new drug. Assuming that the market size and expected market penetration rate of the target disease are known, it has been shown that out-licensing after phase 1 or phase 2 of clinical trials is a best alternative that maximizes Biotech's profits. This study can provide a conceptual framework for the use of management science methodologies in pharmaceutical fields, thus laying the foundation for knowledge and research on out-licensing of new drugs.