• Korean Journal of Veterinary Research
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• v.55 no.2
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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.

• Korean Journal of Clinical Pharmacy
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• v.28 no.4
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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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• v.57 no.1
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• pp.22-27
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• 2019

Nail polish is used to decorate nail beautifully however, it contains lots of toxic materials. Generally, Nail polish consists of film-forming agent, colorant, solvent, surfactant and stabilizer. In this study, to replace toxic chemicals to low irritative, eco-friendly ingredients, we prepared 4 kinds of nail polish and tested safety, stability and performance. Nail polish including shellac/gelatin showed best performance in water-resistance, friability and drying time. When cell toxicity test is done by MTT assay, shellac-gelatin nail polish showed over 70% cell viability at $1,000{\mu}g/mL$ whereas control nail polish in market showed 50% cell viability. At 4 weeks temperature stability test, color was stable at low temperature however it needs formulation improvement at higher temperature.

• Journal of Food Hygiene and Safety
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• v.33 no.1
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• pp.83-88
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• 2018

The purpose of this study was to investigate and evaluate the safety of the wet tissues. In this study, we analyzed sterilizing preservatives and the presence of harmful substances in 62 wet tissue samples in the market. The contents of preservatives, formaldehyde and methanol were analyzed by HPLC and headspace-GC, respectively. Cetylpyridinium chloride was detected as 7-13 ppm in 5 samples. Sodium benzoate was detected in 46 samples ranging from 200 ppm to 3500 ppm, and 9 ppm of methylparahydroxy benzoate was detected in 1 sample. Propylparahydroxy benzoate was not detected in any samples. 5 ppm of methylchloroisothiazolinone and 140 ppm of methylisothiazolinone were detected in 1 sample. Formaldehyde was detected as $0.0069-1.796{\mu}g/g$ in 59 samples. Methanol was detected ranging from 2 ppm to 51 ppm in 22 samples, and 4 samples showed more than 20 ppm of the legal limit. The pH of the wet tissues was 4.0 to 8.2. Continuous investigation and monitoring are necessary to ensure safe distribution of products.

• Analytical Science and Technology
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• v.25 no.2
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• pp.152-157
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• 2012

Currently, many types of compound preparations are being used but the quality control guidelines for their use are lacking. In case of single compound drug, the quality control methods are specified in the pharmacopeia. However, there is no method to simultaneously analyze compound preparations. In this study, a simple validated analytical method for HPLC separation of chlorquinaldol and promestriene is introduced. Validation was divided into categories including linearity, precision, accuracy (recovery) and system suitability. The contents of the products which are on the market were monitored using the validated analytical method and the robustness of the analytical method was tested by conducting an inter-laboratory validation.

• The Journal of Korean Medicine
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• v.30 no.6
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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.

• Proceedings of the PSK Conference
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• 2003.10b
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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)

• Proceedings of the PSK Conference
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• 2003.10b
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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)

• Proceedings of the Ginseng society Conference
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• 1980.09a
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• pp.217-222
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• 1980

By means of numerous examples the practical possibility is demonstrated, which HPLC offers at the quality control of Ginseng-preparations. The method is not only suitable for quali-quantitative evaluation of finished products, but also for in-process controls at production of Ginseng specialities. From the examination of various German products which are on the European market, it results, that the contents of Ginsenosides fluctuate strongly. The mechanisms are shown, which could cause destruction of the Ginsenosides at the processing of Ginseng roots. The guiding principles for the production of standardized Ginseng preparations are defined.

• Journal of Technology Innovation
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• v.20 no.1
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• pp.141-167
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• 2012

Along with technological innovation, successful market entry of a new product is important for sustainable innovation of a firm. In this paper, we examined factors that affect successful introduction of new branded drugs in pharmaceutical industry. Under competing theories of the first mover's advantage and the late mover's advantage, this research focuses on how latecomers can overcome the disadvantages of late entry and catch up to the market leader. First, late movers can absorb the knowledge leaked from pioneering product during the time lag between early entrants and late entrants. Therefore, the time lag provides late entrants an opportunity to catch-up to market leader by differentiating and improving the quality of new product. Second, superior marketing capability of late entrants can enhance the possibility of catching-up, by overcoming the consumer base of early entrants.