• 약학회지
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• 제60권3호
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• pp.146-153
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• 2016

Over-the-counter (OTC) drugs refer to medicines that are generally safe when used according to the product label. We aimed to assess and reflect upon changes in perception of health and health-related demands by decades in Korea according to the consumption and sales trends of OTC drugs. This study was conducted by literature search on the production and sale rankings of OTC drug market in Korea. Changes in the OTC drug market were analyzed and organized by decades to evaluate changes in drug demands and the influence of national and societal factors. There was a specific trend in the most popular drugs by decades. In the 1950s, drugs of top necessity were antibiotics and helminthics. In the 1960s, the pharmaceutical industry quickly grew and invigorators, such as Bacchus$^{(R)}$, Alps$^{(R)}$, Aronamin$^{(R)}$, were top manufactured drugs. Popularity of these invigorating drinks and vitamin products continued until the 1990s. In 1990s, sales of topical nonsteroidal anti-inflammatory drugs (Ketotop Plaster$^{(R)}$, Trast Patch$^{(R)}$), and in 2000s, gum disease medicine (Insadol$^{(R)}$) and liver and intestine supplement (Ursa$^{(R)}$) were prominent. However, after the separation of prescribing and dispensing in 2000, the sales of OTC drugs decreased dramatically from 58.7% of the total market share in 1990s to 39.6% in 2000 and this trend has continued. In 2012, thirteen OTC drugs were allowed to be sold in convenience stores, and as the sales of health functional foods have been expanding beyond pharmacies, sales of invigorators and nutritional supplements in pharmacies have continued to decrease. As government's drug expenditure will continue to grow, reclassification of OTC drugs based on established safety information and deliberate team efforts on continued development of OTC drugs to meet the health demands of Koreans are required by the healthcare professionals, pharmaceutical industries, and the government.

• 대한본초학회지
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• 제27권2호
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• pp.1-16
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• 2012

Objective : To investigate the current status of prescription drugs in Oriental medical institutes and to draw up a future plan for the revitalization of Oriental medical health insurance, this survey has been performed. Method : The survey has been made with 321 doctors working at Oriental medical institutes in Daegu and Kyungbuk areas for a period of 3 month from June 1, 2010 until September 1, 2010. Result : 1. When it comes to the current status of the use of herbal drugs in Oriental Health insurance, most of doctors surveyed prescribe insurance drugs, and they prescribe insurance drugs to patients, who are less than 20% of total patients visiting their clinics. 2. The awareness of Herbal Health Care Drugs is investigated. When it comes to the understanding of the difference between insurance drugs(powder type drugs) and granular type drugs, doctors admit that they differ only in one aspect, whether or not their being covered by health insurance. Based on the survey results on the understanding of insurance coverage of granular type drugs, doctors, even though they long for granular type drugs to be accepted as insurance drugs, are worrying whether the number of outpatients might dwindle due to increased insurance co-payments. They also point out that the biggest obstacles in the expansion of the granular type drugs as insurance drugs are the lack of understanding of the government and the objection of the Health Insurance Review and Assesment service (HIRA) for fear of increased insurance claims. 3. Upon investigation on Oriental medicine doctors' understandings of herbal pharmaceutical industry, it is found that doctors' responses on pharmaceutical industry are not all positive ones('new product development and neglect of R&D infrastructure' and 'smallness of industry'). When it is investigated what area needs the greatest improvement in herbal pharmaceutical industry, 'securing sufficient capital, good manufacturing, and strengthening quality control', is the highest. 4. When it is asked what are the most needed in order to improve herbal health insurance medicine, responses such as 'the increase in the accessibility to and the utilization of Oriental medical clinics through the diversification of the means of prescriptions', 'the improvement of insurance benefits(cap adjustments)', 'increase the proportion of high quality medicinal plants', 'the ceiling of co-payments(deductible) at 20,000 won or more', 'expansion of the choices of formulations', 'formulational expansions of tablets and pills', and finally 'admittance and expansion of granular type drug as insurance drug' are the highest. 5. Upon investigating the general characteristics of the current status of the usage of Oriental health care herbal drugs, the followings are observed. First, the frequency of use of health insurance drugs by the doctors who use health insurance with general characteristics shows similar differences in case of total monthly sales amount (p<0.001), average number of daily patients (p<0.05). Secondly, as to the willingness of the expanded usage of insurance drugs, similar differences are observed in case of total monthly sales amount (p<0.05). 6. Upon investigating the general characteristics of the perception of Herbal health care drugs, the followings are observed. First, inspecting general characteristics and insurance claims due to increased co-payments(deductible amount) reveals similar differences in case of working period (p<0.01) and in case of total monthly sales amount (p <0.01). Secondly, inspecting general characteristics and the obstacles that hinder granular type drugs from being accepted as health care insurance drugs shows similar differences in case of working period (p<0.05). 7. Upon investigating the general characteristics of the understanding of Oriental Herbal pharmaceutical companies, the followings are observed. First, opinions on the general characteristics of pharmaceutical companies, when examined with variance analysis, shows similar differences in case of total monthly sales amount (p<0.05). Secondly, when opinions are examined on general characteristics and the problems of herbal pharmaceutical companies, similar differences are found in case of working period (p<0.01) and in case of total monthly sales amount (p<0.001). Lastly, opinions on the general characteristics and reforms of pharmaceutical companies, similar differences are observed in case of working period (p<0.001). 8. Upon investigating the general characteristics of the improvement of insurance Herbal drugs, the followings are observed. First, regarding general characteristics and insurance benefits, similar differences are observed in case of working period (p<0.05), in case of total monthly sales amount (p<0.05), and in case of average number of daily patients (p<0.01). Secondly, opinions on the general characteristics and the needs for the improvement of Herbal insurance drugs are examined in 5 different aspects, which are the approval of granular type drugs as insurance drugs, the expanded practices of the number of prescription insurance drugs, the needs of a variety of formulations, the needs of TFT of which numbers of Oriental medical doctors are members for the revision of the existing system, and the needs of adjusting the current ceiling of the fixed amount and the fixed rate. When processed by the analysis of variance, the results show similar differences in case of average number of daily patients (p<0.01). Conclusion : From the results of this study the first measures to take are, to reform overall insurance benefit system, including insurance co-payment system(fixed rate cap adjustment), to expand the number of the herbal drugs to be prescribed matching with insurance benefit accordingly, and to revitalize herbal medicine insurance system through the change of various formulations. In addition, it is recommended to improve the effectiveness of herbal medicine by making plans to enhance the efficacy of herbal medicine and by enabling small pharmaceutical companies to outgrow themselves.

• Journal of Pharmaceutical Investigation
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• 제34권1호
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• pp.57-71
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• 2004

The objective of this study was to provide a better understanding of SUPAC-IR and its application in handling postapproval changes to immediate release solid oral dosage forms. Originally, SUPAC-IR was aimed at reducing the regulator burdern of the industry when they were making postapproval changes, but still at maintaining the formulation quality and performance of a drug product. The postapproval changes that were covered under SUPAC-IR included variations in the components ad composition of formulation, the site of manufacturing, batch size, manufacturing equipment, and manufacturing process. The guidance defined levels of changes, based on the likelihood of risk ocurrence and potential impact of postapproval changes upon the safety and efficacy of a drug product I suggested what a type of fing report should be submitted to the FDA for each level of change. Chemist, manufacturing, and control tests to be executed were also recommended for each change level The important tests specified in the guidance included batch release, stability, in vitro dissolution, and in vivo bioequivalence tests. However, there have been strong demands on revising the current SUPAC-IR in order to resolve some issues and to improve its usefulness in evaluating postapproval changes to immediate release solid oral dosage forms. In particular, the rigorous requirement of case C dissolution test and the definition of batch size were challenged by both academia and the industry. A revision work was in progress to reflect these inputs and to expand the utility of SUPAC-IR. As a result of these concerted efforts, an updated 2nd version of SPAC-IR would be likely to be issued ver soon to the public.

• Journal of Pharmaceutical Investigation
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• 제34권3호
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• pp.229-254
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• 2004

The objective of this study was to scrutinize the rationale of SUPAC-MR and its application in processing postapproval changes to modified release solid oral dosage forms. The types of postapproval changes that were primarily covered with SUPAC-MR included variations in the components and composition, the site of manufacturing, batch size, manufacturing equipment, and manufacturing process. SUPAC-MR defined levels of postapproval changes that the industry might make. Classification of such categories was based on the likelihood of risk occurrence and potential impact of changes upon the safety and efficacy of approved drug products. In most cases, the changes could be classified into 3 levels. It described what chemistry, manufacturing, and control tests should be conducted for each change level. The important tests specified in SUPAC-MR were batch release, stability, in vitro dissolution, and in vivo bioequivalence tests. It then suggested what type of a filing report should be submitted to the FDA for each change level. In general, level 1 changes could be reported in an annual report, whereas level 2 and/or 3 changes could be submitted in changes-being-effected or prior approval supplements. It could be understood that the purpose of SUPAC-MR was to maintain the safety and quality of approved modified release solid oral dosage forms undergoing certain changes. At the same time, it contributed to providing a less burdensome regulatory process with the manufacturers when they wanted to make postapproval changes. European regulatory agencies also implemented SUPAC-like regulations in handling such changes to drug products. Therefore, in this study a recommendation was made for KFDA and the Korean industry to evaluate thoroughly the usefulness of these guidances and regulations in dealing with postapproval changes to modified release solid oral dosage forms.

• 약학회지
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• 제53권4호
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• pp.173-178
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• 2009

This study aimed to analyze the master's and doctoral theses in social pharmacy field over the past 10 years in Korea. Theses were searched based on the Korean National Assembly Digital Library System, and descriptive analyses were conducted using SAS. Among 669 theses, pharmacy/pharmacist accounted for 24.8%, followed by drug misuse with 16.9%, and pharmaceuticals industry related theses with 16.6%. Graduate school of pharmacy was responsible for a share of 27.2%, suggesting that approximately a quarter of the entire social pharmacy related theses are studies at the school of pharmacy.

• 한국콘텐츠학회논문지
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• 제16권9호
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• pp.443-450
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• 2016

국내 바이오의약산업은 국가의 핵심전략 사업으로써 고부가가치 산업이다. 고령화로 인한 의약품 수요증가, 신약 R&D 투자성과 가시화, 바이오의약 중심의 R&D 변화, 전략적 해외 기술수출 확대, 정부의 적극적 지원으로 인하여 해외 시장 진출이 급속도록 가속화되고 있다. 따라서 국내 제약회사도 글로벌 제약기업으로써의 경쟁력을 강화하고 소비자들에게 신뢰 받을 수 있는 기업으로써의 이미지 구축이 절실하다. 이에 본 연구는 마케팅 수단으로써의 CI의 중요성을 인식하고 국내 제약회사의 CI 심벌마크 시각적 특징 분석과 연령대별 선호도를 비교 분석하였다. 그 결과 심벌마크에 대한 선호도는 연령대가 높아질수록 제작년도가 오래된 심벌마크에 대한 선호도가 크게 높은 것으로 나타났으며 인지도와 비례하였다. 또한 픽처마크형 심벌마크가 워드마크 형태보다 절대적으로 선호되었다. 제약회사의 글로벌화를 위하여 기업 역시 대중의 인식변화에 대한 책임감이 요구되며 본 연구가 글로벌 경쟁력이 있는 국내 제약회사의 이미지 제고를 위한 아이덴티티 전략의 기초자료로써 심벌마크 개발 방향에 도움이 되기를 기대한다.

• 산업경영시스템학회지
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• 제46권4호
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• pp.74-92
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• 2023

The computer system validation consulting industry is growing as domestic GMP companies' overseas exports or advancements increase, and computer system validation has been mandatory in Korea since the 2010s, but domestic CSV consulting companies are small in size and have a short history, revealing many shortcomings in terms of service quality and customer satisfaction when conducting consulting. Research related to consulting has been mainly focused on management consulting and IT consulting, and research related to computer system validation is very insufficient. This study confirmed the effect of consultant competency and service quality on consulting performance, customer satisfaction, and intention to renew contract when performing computer system validation through empirical research on food, pharmaceutical, cosmetics, and medical device companies, which are representative companies in the GMP industry. As a result, it was confirmed that consultant competency and service quality had a significant effect on consulting performance, customer satisfaction, and intention to renew contract. In addition, it was confirmed that the reputation and expertise of consulting companies had a moderating effect on the relationship between consultant competency and consulting performance.

• 유통과학연구
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• 제6권2호
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• pp.41-60
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• 2008

본 연구는 국내 제약 산업의 현황과 유통시스템을 조사하였다. 본 연구에서는 국내 제약 산업 유통시스템의 문제점을 찾아내고 그에 따른 개선점도 동시에 제시하였다. 연구는 국내 제약 산업의 유통시스템을 개선하기 위해서 국내 제약 제조의 선도기업인 'J'기업의 10가지 유통시스템을 대상으로 조사하였으며 그에 따른 유통시스템의 개선점도 찾을 수 있었다. 본 연구는 'J'기업의 2008년 4월 1일부터 7월 31일까지의 내부 보고서를 중심으로 자료를 수집하였으며 또한 지속적인 담당자 면접을 통해 유통시스템의 문제를 밝혀냈다. 그 결과 의약공급 유통시스템의 문제점으로 첫째, 직접 판매 비즈니스의 부정적 효과를 가졌고 둘째, 생계유지형의 영세한 구조였다. 셋째, 도매유통이 넘쳐나고 불법적인 거래가 보편적이었다. 이러한 문제점을 극복하기 위해서는 다음과 같은 몇 가지 대안이 시급히 마련되어야 한다. 첫째, 도매유통시스템의 역할과 기능을 더욱 강화해야 하며 둘째, 도매유통시스템 관리자의 신중한 유통시스템의 재설계가 필요하다. 셋째, 상적 유통이 더 업그레이드(upgrade) 되어야 하며 넷째, 물적 유통 또한 추가적인 업그레이드가 필요하다. 마지막으로 의약공급 유통시스템 문제 해결을 위해서 투명하고 활동적인 정보시스템이 반드시 이루어져야 함을 제시한다.

• Journal of Pharmaceutical Investigation
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• 제34권1호
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• pp.73-79
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• 2004

The union of information-technology and biology presents great possibilities to both applications of bio-information and development of science and technology. Also, meaningful analysis of bio-information brings about a new innovation in the field of bio-market with the advent and growth of bioinformatics. Hence, bioinformatics is the most import aspect for establishing a science-technology-oriented society in the $21^{st}$ century. This article provides trends in current state of bioinformatics. Technological development of bioinformatics for the rapid growth of bio-industry means that using bioinformatics, a biologist can process and store enormous amount of data such as current Human Genome Project and future data in the field of biology. We have manly looked at the tends of bio-information, databases and mining tools that are generally used, and strategies and directions for the future.

• 한국자원식물학회지
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• 제32권4호
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• pp.275-281
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• 2019

The pathological condition of excessive melanogenesis causing freckles, melasma, senile lentigo, pigmented acne scars, and cancer has a critical impact on the wellness of individuals. The mechanism of melanogenesis is related to the expression of melanogenic enzymes. Here, we evaluated the inhibitory effect of pine cone (Pinus densiflora) extracts on melanogenesis. P. densiflora, the Korean Red Pine, is the predominant tree species in the cool, temperate forests of northeast Asia, occurring in pure stands across Korea, Japan, and parts of northern China and Russia. P. densiflora leaves, pollen, and bark have been widely used for traditional medicine, or edible purposes. However, pine cones are rarely used as natural raw materials, although they contain many bioactive phytochemicals. The pine cone ethyl acetate fraction (PEF) showed no toxicity to B16F10 cells at a concentration of less than $100{\mu}g/mL$. PEF inhibited the expression of microphthalmiaassociated transcription factor (MITF), tyrosinase and tyrosinase-related factors in B16F10 cells treated with 3-Isobutyl1-methylxanthine (IBMX). These results suggest that pine cones can be used as an effective natural melanogenesis inhibitory agent.