• Journal of Society of Preventive Korean Medicine
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• v.5 no.1
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• pp.57-75
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• 2001

This study was conducted to improve the current regulation guidelines for developing traditional Korean medicines with effectiveness and productivity, in order to cope with the upcoming ICH on specifications on oriental herbal drugs. Also, major purposes of this study are to motivate R&D and to pioneer foreign markets for domestic herbal drug companies. First, after examining concepts of traditional Korean medicines and comparing the numbers and differentiation of herbal drugs registered on Pharmacopeia among Korea, China, and Japan, the current new drug development requirements for traditional Korean medicines were reviewed in detail, followed by comparison of foreign regulation systems including USA, EU, China, and Japan. Second, empirical cases on failure of development for new traditional Korean medicines under the current regulation system in the domestic companies including Dong-A, Kwangdong, and Samchondang, were collected and analyzed. As a result, hanbangsaengyak, the new category for traditional Korean medicines was newly developed on the basis of scientification of data between saengyak and hanyak, from the perspectives of harmonization between oriental medicine and western medicine and of balance between food and drug, in terms of industrialization, publicity, modernization, and effectiveness of administration. In addition, the new regulation requirements for the new hanbangsaengyak preparations were discussed by establishing principles of reinforcing preclinical test and of simplifying clinical trials in Korea. Finally, the further researches to articulate the complete specifications for pre-clinical and clinical requirements for traditional Korean medicines were strongly suggested.

• The Journal of Health Technology Assessment
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• v.6 no.2
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• pp.156-161
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• 2018

Objectives: To evaluate results and workloads of the horizon scanning of the emerging health technology since 2014 to 2016. Methods: In order to analyze the results of the emerging health technology, we identified the number of research procedure between 2014 and 2016. The sixteen findings were calculated annual workload by person, and categorized by medical phase, classification of disease, and healthcare technology. Results: An average of 5.67 personnel were involved over three years, assessment of each emerging healthcare technology was performed for each person of identifying 54 cases, filtering 2.4 cases, prioritizing 0.9 cases were performed. According to the mapping by healthcare technologies, nine medical devices (56.3%), six drugs (37.5%), and one material of the medical treatment (6.3%) were assessed. Among sixteen findings, fifteen cases were health technologies for treatment and only one case for diagnosis. Conclusion: Future plans of the horizon scanning of the emerging health technology is required appropriate manpower in charge each target number of assessment. And a legal basis should be provided for policy reflection rate. Furthermore, an evaluation criteria and procedures should be transparent to avoid a conflict of interest.

• YAKHAK HOEJI
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• v.54 no.5
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• pp.362-369
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• 2010

Despite the fact that the dissolution test can serve as an effective tool for drug quality control and prediction of in vivo drug performance, there are a number of drugs with no established dissolution specifications because they were developed quite a long time ago. Under this circumstances, KFDA started the new project that establishes dissolution method and specifications for drugs with no dissolution specifications listed in the Korea Pharmaceutical Codex (KPC). This project aims for promoting the appropriate management of oral solid dosage forms. Seoul regional KFDA selected 2 items, Nicametate citrate tablet and Norfloxacin capsule, for establishing dissolution specifications. We went through the following procedures to develop the dissolution method and specifications: (1) Validation of dissolution test equipment, (2) Purchase of test drugs, (3) Preliminary test with one of the test products (1 lot), (4) Validation of analysis methods (3 lots), (5) Final tests and cross tests among other laboratory to establish dissolution specifications, (6) Additional test with the other test drugs. The outcome of this study will be reflected in revision of the KPC. It is believed that the quality control and evaluation of oral solid dosage forms listed in KPC will be advanced with the revision which adds additional dissolution test and specifications for the drugs with no established dissolution specifications.

• The Journal of the Convergence on Culture Technology
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• v.4 no.4
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• pp.387-392
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• 2018

Clinical trials are an important part of developing new medical devices or developing new drugs. However, it takes many time and expense to conduct clinical trials. In order to solve this problem, it define the standard format of the data collected in clinical trials in major countries and in Korea. Clinical trials are also underway in korean medicine to develop new medical devices. If it define the standards for the data we collect in clinical trials, there are likely to be a variety of ways to use them. If it collect and manage various clinical trial data as one standardized data, you will be able to draw various results. Based on these findings, we established a system for collecting and managing integrated data on clinical trials. And let's look at how to use it.

• Journal of Korea Technology Innovation Society
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• v.18 no.4
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• pp.667-692
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• 2015

The study examined the Korean medicine industry from the perspective of the innovation system theory of each business, while it concentrated on the conflict between traditional Korean medicine and Western medicine, which have a major influence on the innovation system of Korean medicine industry, rather than the innovation system itself. The Korean healthcare system is a dual system of Western and Korean medicine, yet the definitions of Western medical practices and Korean medical practices are ambiguous. Thus the distinction of dual system depends on judicial precedents, and the innovation of Korean medicine has been inhibited due to the excessive emphasis placed on the Western medical practice in both healthcare system and pharmaceutical system. First of all, the usage of most medical devices derived from the development of modern medical engineering is not permitted in the Korean medicine industry, on the basis that most of the medical devices were originated from the Western medicine field. Secondly, new drugs using natural substances, once approved by the drug administration, cannot be prescribed by the Korean medicine industry although they are developed based on Korean medicine. Thirdly, the major safety issues on herbal medicine are about hazardous materials in medicinal herbs and liver toxicity of prescribed herbal medicine. The problem of hazardous materials can be solved by appropriate quality and safety tests in the cultivation and importation process. Whereas the Korean medicine circles points out that the liver toxicity issue is only a unilateral condemnation by the Western medicine circles.

• Biotechnology and Bioprocess Engineering:BBE
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• v.10 no.1
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• pp.9-15
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• 2005

A bioartificial liver (BAL) is a medical device entrapping living hepatocytes or immortalized cells derived from hepatocytes. Many efforts have already been made to maintain the functions of the hepatocytes in a BAL device over a long term. However, there is still some uncertainty as to their efficacy. and their limitations are unclear. Therefore, it is important to quantitatively evaluate the metabolic functions of a BAL. In previous studies on in vitro BAL devices, two test methods, an initial bolus loading and constant-rate infusion plus initial bolus loading, were theoretically carried out to obtain physiologic data on drugs. However, in the current study, the same two methods were used as a perfusion model and derived the same clearance characterized by an interrelationship between the perfusate flow rate and intrinsic clearance. The interrelationship indicated that the CL increased with an increasing perfusate flow rate and approached its maximum value, i.e. intrinsic clearance. In addition, to set up an in vivo BAL system, the toxic plateau levels in the BAL system were calculated for both series and parallel circuit models. The series model had a lower plateau level than the parellel model. The difference in the toxic plateau levels between the parallel and series models increased with an increasing number of BAL cartridges.

• Proceedings of the Korean Institute of Information and Commucation Sciences Conference
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• 2021.05a
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• pp.323-325
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• 2021

With the recent revitalization of virtual reality and game industries, digital therapeutics for medical purposes are emerging. Digital therapeutics refer to sports-based therapeutics such as virtual reality contents and games that are effective in preventing, managing, and treating diseases, not drugs. Through this study, we plan and develop contents for healing and brain enhancement using virtual reality technology as a therapeutic digital therapy. Through this, it can help to improve the brain of children who are dependent on electronic devices in the digital age and rarely use their brains.

• International journal of advanced smart convergence
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• v.11 no.1
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• pp.111-116
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• 2022

After COVID-19, the number of people with sleep disorders around the world is increasing. In particular, in the flow of the 4th industrial revolution, the differentiation of types and characteristics of the sleep industry is accelerating. Therefore, in this study, the characteristics of each type of sleep-related industry were reclassified from an industrial point of view, and based on this, an attempt was made to review the classification system that can help companies develop sleep products and improve related national systems. Based on the 10th standard industry classification, we compared input cost, value, and usability and analyzed common characteristics, treatments, and preventive effects based on this. A comprehensive taxonomy using matrix analysis was reviewed. As a result, in terms of cost (A), the most common sleeping products are general mattresses and general bedding. It is an IOT device (auxiliary device), and the value aspect (B, B/D) included sleep cafe, bedding rental and management service, and sleep consulting. In terms of utility (A/B), a total of 6 product groups including sleep aids (health functional foods) belong to this category, and in terms of treatment (A/C), a total of 3 product groups including sleep clinics (medical services) belong to this category. As for the product group (A/D) with both properties, it was found that non-insurance sleep treatment medical devices, sleep-related over-the-counter drugs, and some sleep monitoring applications belong to this category. Ultimately, it was found that the sleep industry classification enables the most active product development and composition according to the relative relationship between cost and utility, and treatment and utility. appeared to be necessary.

• Asian Pacific Journal of Cancer Prevention
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• v.17 no.3
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• pp.1255-1259
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• 2016

Background: Oral physiotherapy or mouth exercise is considered to be an adjunct but mandatory treatment modality for oral submucous fibrosis (OSMF). This study planned to evaluate the clinical efficacy of a newly designed mouth exercising device (MED) in OSMF patients receiving local ointment, intra-lesional drugs and surgical treatment. Materials and Methods: A total of 231 OSMF patients were selected and treated with basic regime including topical corticosteroids, oral antioxidants and the icecream-stick exercise regime and allotted randomly to two equal groups A and B. Group-A patients were additionally given MED. Subgroups A1 and B1 patients with an inter-incisal distance (IID) 20-35mm were not given any additional therapy; subgroup A2 and B2 patients (IID 20-35mm) were treated additionally with intra-lesional injections. Subgroups A3 and B3 with IID<20mm were managed surgically. IID was measured at baseline and at 6 months recall. The change in IID measurements was calculated and statistically analyzed using 2-way ANOVA and Tukeys multiple post hoc analysis. Results: Average improvement in IID after six months of recall visits was observed to be 8.4 mm in subgroup-A1 (n-53) compared to 5.5 mm in B1(n-50) (p<0.01). The IID improvement in subgroup-A2 was found to be 9.3mm (n-46) compared to 5.1 mm in B2 (n-48) (p<0.01). In the surgery group, mouth opening improvement was observed to be 9.6 mm in subgroup A3 (n-18) compared to 4.8 mm for B3 (n-16) (p<0.01). Conclusions: Use of the MED appears to be effective for increasing oral opening in OMSF patients in conjunction with local, injection and/or surgical treatment.

• Investigative Magnetic Resonance Imaging
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• v.23 no.4
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• pp.296-315
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• 2019

Cardiac magnetic resonance (CMR) imaging is widely used in many areas of cardiovascular disease assessment. This is a practical, standard CMR protocol for beginners that is designed to be easy to follow and implement. This protocol guideline is based on previously reported CMR guidelines and includes sequence terminology used by vendors, essential MR physics, imaging planes, field strength considerations, MRI-conditional devices, drugs for stress tests, various CMR modules, and disease/symptom-based protocols based on a survey of cardiologists and various appropriate-use criteria. It will be of considerable help in planning and implementing tests. In addressing CMR usage and creating this protocol guideline, we particularly tried to include useful tips to overcome various practical issues and improve CMR imaging. We hope that this document will continue to standardize and simplify a patient-based approach to clinical CMR and contribute to the promotion of public health.