• Archives of Pharmacal Research
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• 제29권7호
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• pp.605-616
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• 2006

A wide variety of drugs and endogenous bioactive amines are organic cations (OCs). Approximately 40% of all conventional drugs on the market are OCs. Thus, the transport of xenobiotics or endogenous OCs in the body has been a subject of considerable interest, since the discovery and cloning of a family of OC transporters, referred to as organic cation transporter (OCTs), and a new subfamily of OCTs, OCTNs, leading to the functional characterization of these transporters in various systems including oocytes and some cell lines. Organic cation transporters are critical in drug absorption, targeting, and disposition of a drug. In this review, the recent advances in the characterization of organic cation transporters and their distribution in the small intestine are discussed. The results of the in vitro transport studies of various OCs in the small intestine using techniques such as isolated brush-border membrane vesicles, Ussing chamber systems and Caco-2 cells are discussed, and in vivo knock-out animal studies are summarized. Such information is essential for predicting pharmacokinetics and pharmacodynamics and in the design and development of new cationic drugs. An understanding of the mechanisms that control the intestinal transport of OCs will clearly aid achieving desirable clinical outcomes.

• Asian Journal of Business Environment
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• 제12권4호
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• pp.35-44
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• 2022

Purpose: The main purpose of this study is to find out the impact of ownership structure on firm performance in the pharmaceutical and chemical industry of Bangladesh. Research design, data and methodology: The study has been conducted on 28 listed pharmaceutical and chemical companies from 2012 to 2020. Return on Assets (ROA) and Tobin's Q are selected as indicators of internal and market performance of the firms respectively whereas institutional ownership, directors' ownership and foreign ownership are selected as proxies of ownership structure. Panel analysis using random effects, lag method and time dummy method is used to analyse the relationship. Results: The study has found the existence of highly concentrated directors' ownership, a low percentage of institutional ownership and a very insignificant proportion of foreign ownership in the industry. The regression results show that directors' ownership has a positive and significant impact on firm performance, supporting the concept of agency theory. The study has also found a positive and significant impact of foreign ownership on firm performance. Unfortunately, the impact of institutional ownership is found to be insignificant. Conclusions: Directors' ownership and foreign ownership decreases agency cost that ultimately increases firm performance. However, the role of institutional investors is not significant enough to improve firm performance. It is suggested that institutional investors should be more active and involved in monitoring the activities of the organisations to improve performance.

• 대한수의학회지
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• 제55권2호
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• pp.97-103
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• 2015

In this study, the Korean veterinary medical devices management system was evaluated relative to systems in the USA, EU, and Japan. Veterinary medical devices are regulated in Korea based on the Medical Appliance Act of 1997. This was initially supervised by the Ministry of Agriculture, Food and Rural Affairs and Korea Animal Health Products Association, and subsequently by the Animal and Plant Quarantine Agency (QIA) in 2000. These devices were classified approximately 1,400 categories as instruments, supplies, artificial insemination apparatus, and other categories. Each of these devices was assigned to four regulatory grades by the QIA in 2007. The ranking system for veterinary medical devices was implemented in 2014 with 820 products from 162 companies registered by that year. However, in vitro diagnostic devices (IVDDs) for animals were managed as medical devices and biological medicine. In vitro diagnostic reagents for treating infection diseases are not subjected to either a classification or grading system. Veterinary medical devices are currently exempt from good manufacturing practices (GMP) and device tracking requirements. Due to gradual growth of the domestic veterinary medical devices market since 2008, regulation of these devices should be improved with re-examination of IVDDs and GMP certification for the effective operating system.

• 한국임상약학회지
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• 제28권4호
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• pp.263-272
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• 2018

Nonprescription drugs have become increasingly important in Korean healthcare. By leveraging lower-cost drugs and reducing expenditure associated with fewer physician visits, the nonprescription segment can deliver tremendous value to individual consumers and the Korean healthcare system. Many countries have provided simpler and more rapid routes to market entry for qualifying nonprescription drug products, using the established data on drug safety and efficacy, as well as public and professional opinion. In US, the FDA waived the pre-approval process for over-the-counter (OTC) drugs marketed through the OTC Monograph Process. In Australia and Canada, different OTC product application levels are defined, with a reduced level of assessment required when the risks to consumers are considered low. Japan established a new OTC evaluation system in 2014 to facilitate the Rx-to-OTC switch process. The legislative framework for medicinal products in the European Union allows for drugs to be approved with reference to appropriate bibliographic data for old active substances with well-established uses. Through a comparison of the regulatory framework and the requirements for nonprescription approval process in different countries, several ways to improve regulatory practice for the evaluation of nonprescription drugs in Korea have been suggested.

• Korean Chemical Engineering Research
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• 제57권1호
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• pp.22-27
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• 2019

매니큐어는 손톱을 아름답게 꾸미기 위해 사용하는 색조화장품이지만 그 구성성분은 유해성분이 상당히 포함되어 있다. 매니큐어는 일반적으로 피막형성제, 색소, 용제, 계면활성제 및 침전방지제 등으로 구성되어 있다. 본 연구에서는 유해성 성분을 저자극, 친환경적인 성분으로 대체하여 4종의 매니큐어를 제조하고, 매니큐어로서 효력 비교실험과 안전성 및 안정성 시험을 실시하였다. 효력비교실험에서 쉘락/젤라틴 매니큐어 조성물(No. 4)이 내수성 및 적당한 강도를 지니면서 건조시간이 2분 내외로 대조군(4분 내외)보다 우수하고 악취도 개선되어, 피막형성제로서 가장 우수한 특성을 보여주었다. 또한 쉘락/젤라틴 매니큐어 조성물의 세포독성시험 결과, $1,000{\mu}g/mL$ 농도에서 70% 이상의 세포생존율로 시판되고 있는 매니큐어(50% 세포생존율)보다 독성이 낮았다. 4주간 온도 안정성 시험에서 저온에서는 색상의 변화가 없었으나, 상온과 고온에서 외관상변화 및 점도변화가 관찰되어 추후 제형의 개선이 필요한 것으로 생각된다.

• 한국식품위생안전성학회지
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• 제33권1호
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• pp.83-88
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• 2018

시중에 유통 중인 물휴지 62 품목을 선정하여 살균보존제 성분 및 유해물질 함유 여부 등의 안전성을 조사하였다. 일반적으로 화장품 및 식품에 가장 많이 사용하는 살균 보존제인 안식향산나트륨은 46 품목에서 200~3500 ppm 검출되었고 파라벤류는 1 품목에서 파라옥시안식향산메칠이 9 ppm 검출되었다. 사용할 수 없는 살균보존제인 메칠클로로이소치아졸리논과 메칠이소치아졸리논(3:1)혼합물이 1 품목에서 검출되어 부적합 판정되었으며, 메칠클로로이소치아졸리논 5 ppm, 메칠이소치아졸리논 140 ppm 검출되었다. 염화세틸피리디늄은 5 품목에서 7~13 ppm 검출되었으며, 모두 허용기준 이내로 나타났다. 잔류유해물질인 포름알데히드 검사결과는 $0.069{\sim}1.796{\mu}g/g$로 허용기준인 $20{\mu}g/g$ 이하였다. 메탄올은 5~51 ppm 검출되었으며, 이 중 4 품목에서 허용기준인 20 ppm보다 2배 이상의 농도가 나타났다. 안전한 제품이 유통될 수 있도록 메탄올의 잔류경로에 대한 지속적인 조사 및 모니터링이 필요하다고 판단된다. 물휴지의 pH를 측정한 결과 4.0~8.2로 나타나 유통화장품의 pH 3.0~9.0 기준에 적합하였으나, 물휴지에는 pH 기준이 설정되어 있지 않으므로 안전관리를 위해서는 pH 기준을 설정하는 고시개정이 필요할 것이다.

• 분석과학
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• 제25권2호
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• pp.152-157
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• 2012

현재 시중에 많은 복방제제가 유통되고 있음에도 불구하고 이의 품질관리를 위한 시험법은 부족한 실정이다. 여러 주효 성분을 가지는 복방제제의 경우 대부분 약전에 수재된 항목 중 2개 이상의 조합으로 구성되어 있으나 약전에 단일 항목에 대한 시험법이 고시되어 있을 뿐 여러 항목을 한번에 시험하는 방법이 없어 한가지 제제를 관리 하는 데에 여러 시험법이 요구되어 효율이 낮고 비용이 높다. 따라서 본 연구는 현재 유통중인 복방제제의 새로운 분석법을 개발한 과정과 그 때에 적용되는 기준을 제시하고 그 결과를 검증하였다. 복방 프로메스트리엔, 클로르퀴날돌 제제에 대한 새로운 분석법을 HPLC를 기반으로 가장 적용이 용이하게 개발하였으며 직선성, 정밀성, 정확성(회수율), 시스템 적합성(반복성, 분리도) 등의 항목에 대하여 밸리데이션을 수행함으로써 분석법을 검증하였다. 또한 개발된 시험법을 이용하여 시중 제품을 모니터링하고 실험실간 밸리데이션을 수행하여 시험법의 견고성을 확인함으로써 새로운 고시안으로서의 가능성을 제시하였다.

• 대한한의학회지
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• 제30권6호
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• pp.96-102
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• 2009

Objectives: Traditional Korean herbal formulae are composed of multiple medicinal plants. This situation of multiple-ingredient mixtures has been considered as a major obstacle to new drug development using herbal formulae in the world market, despite the effectiveness of such mixtures. This study reviewed Liv-52 as a representative model of successful drug development using a multiple-herb mixture. Methods: All articles for Liv-52 were collected from the PubMed database. The history, composition of Liv-52, its pharmaceutical efficacy and mechanisms, and data from clinical studies including its market size were analyzed. Results: Liv-52 is composed of seven herbal plants and it is the best known in Ayurvedic medicine for treating liver disorders. Since its 1955 introduction, forty four international papers have been published based on pre-clinical and clinical trials. The efficacy and mechanisms of Liv-52 were intensively studied. Currently, Liv-52 is one of the top-selling products, with over 10 million dollars sales annually, in the world market. Conclusions: These results indicate that Korean herbal formulae could be new global drugs if scientific evidence for efficacy and standardization are produced via literature researches.

• 대한약학회:학술대회논문집
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• 대한약학회 2003년도 Proceedings of the Convention of the Pharmaceutical Society of Korea Vol.2-2
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• pp.66.1-66.1
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• 2003

Rhizomes of Polygonatum species belong to Liliaceae are important herbal drugs in the traditional medical practice of Asian region. Two representative Chinese drugs derived from this genus are Hwangjeong and Okjuk. Though botanical origins of these drugs are officially listed as P. falcatum, P. sibiricum and P. kingianum for Hwangjeong and P. odoratum var. pluriflorum for Okjuk in the Korean Pharmacopoeia and Korean Herbal Pharmacopoeia, respectively, they are often sold as a mixture of several different species in the market. (omitted)

• 대한약학회:학술대회논문집
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• 대한약학회 2003년도 Proceedings of the Convention of the Pharmaceutical Society of Korea Vol.2-2
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• pp.224.2-224.2
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• 2003

Pyrethroic acids are essential chiral intermediates of the pyrethroids, which account for about 25% of the world insecticide market and are found to be some of the most effective commercially available pesticides. It was demonstrated that polysaccharide-derived chiral stationary phases (CSPs) are very efficient for the separation of the enantiomers of pyrethroid acids. It was observed that the enantioseparation of pyrethroic methyl ester and ethyl derivatives was well accomplished on brush-type WhelkO-1. (omitted)