• 대한한의학원전학회지
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• 제27권4호
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• pp.181-198
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• 2014

Objectives : This study was to analyze definitions of herbal medicinal preparations, crude drug preparations, and new drugs from natural products in the relevant laws and regulations, understand the related problems, and propose directions for improvement. Methods : I analyzed the legal definitions in respect of herbal medicinal preparations, crude drug preparations, and new drugs from natural products in relevant laws and regulations since 1945, explained the problems, and suggested the solution-considering the academic stance of Traditional Korean Medicine and the dualistic medical and pharmaceutical system. Results : Regarding the current laws and regulations that are relevant to herbal medicinal preparations, we should 1) clarify the boundaries between the duty of physicians and that of pharmacists, 2) limit the principles of Korean Medicine as well as the contents of the related textbooks, 3) find a way to protect the intellectual property rights for herbal medicinal preparations, and 4) establish a separate standard for drug classification regarding herbal medicinal preparations. In case of crude drug preparations, we should 1) clarify the meaning and limitations of the phrase, "the point of view of Western medicine," and 2) establish a classification standard for drugs that are used in Korean Medicine and clarify the boundaries between herbal drug preparations and crude drug preparations. Furthermore, laws and regulations apropos of new drugs from natural products do not actually fit the concept of "new drug," and due to subordinate laws, a supplement to a new drug submission is contradictorily misclassified as a new drug from natural products. Conclusions : The problems of legal definitions of herbal medicinal preparations, crude drug preparations, and new drugs from natural products have emerged in the process of giving approval to drugs that are made of herbs and natural products under the dualistic medical and pharmaceutical System. Laws and regulations that differentiate the process of approving herbs that are used in Korean Medicine and the others should be established.

• 한국임상약학회지
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• 제34권1호
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• pp.62-70
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• 2024

Background: Drug-related problems have the potential to threaten patient health, and pharmacists are in a position to prevent such problems through prescription reviews and patient counseling, actively engaging in pharmaceutical care activities. This study aims to categorize and analyze the intervention activities of pharmacists in community pharmacies concerning drug-related problems, following international criteria. Methods: Over a six-month period, prescription interventions completed in a community pharmacy in Seoul were selected as the research subjects. The causes of interventions were classified according to the Pharmaceutical Care Network Europe (PCNE) drug-related problems (DRPs) classification system and the types and frequencies of DRPs were identified. Results: Among a total of 49,334 prescriptions, 527 interventions were completed, constituting approximately 1.07% of the daily average filled prescriptions. Individuals over 60 years of age represented more than 50%. The primary cause of DRPs was prescribing and drug selection issues, comprising 256 cases (48.58%), with specific subcategories including 109 cases of drug selection, 79 cases of treatment duration errors, 47 cases of dose selection, and 21 cases of inappropriate dosage form selection. Patient-related issues accounted for 204 cases (38.71%). Conclusion: The study demonstrated that the pharmacists' intervention in community pharmacies contributes to the safe use of medication by patients.

• 대한의용생체공학회:의공학회지
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• 제44권1호
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• pp.73-79
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• 2023

The purpose of this study is to derive medical devices with different management systems through comparison of domestic and overseas medical device product classification systems and to propose management conversion measures for the products. The definitions of medical devices were compared and the scope of medical devices defined by each country was confirmed through surveys of the Medical Device Act, Federal Food, Drug & Cosmetics Act (FD&C) in the U.S., and Medical Device Regulations (MDR) in Europe. Using the Ministry of Food and Drug Safety's regulations on medical device products and grades, 21 CFR part 860-892 and product code classification files in U.S., and EMDN in Europe as basic data to compare medical device products and derive medical devices with different management systems. As a result of comparing the definition and product classification systems of medical devices in Korea, the U.S. and Europe, medical device accessories, prosthetic limbs and aids among assistive devices for persons with disabilities, drugs, quasi-drugs and industrial products that are not managed by medical devices in Korea are managed as medical devices in the U.S. and Europe. This study aims to improve public health by securing systematic product safety management and essential performance under medical device regulations. Management within a single medical device system will increase the efficiency of licensing work of domestic medical device manufacturers and related organizations. It is also expected to help advance the system according to the international harmony of the item classification system and enhance smooth import and export competitiveness.

• 산업과 과학
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• 제3권2호
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• pp.8-16
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• 2024

본 논문에서는 인구통계학적, 생리학적 특성을 기반으로 환자에게 가장 적합한 약물을 예측하는 것을 목표로 하는 약물 분류 시스템을 제시한다. 데이터 세트에는 적절한 약물을 결정하기 위한 목적으로 연령, 성별, 혈압(BP), 콜레스테롤 수치, 나트륨 대 칼륨 비율(Na_to_K)과 같은 속성들이 포함된다. 본 연구에 사용된 모델은 KNN(K-Nearest Neighbors), 로지스틱 회귀 분석 및 Random Forest이다. 하이퍼파라미터를 최적화하기 위해 5겹 교차 검증을 갖춘 GridSearchCV를 활용하였으며, 각 모델은 데이터 세트에서 훈련 및 테스트 되었다. 초매개변수 조정 유무에 관계없이 각 모델의 성능은 정확도, 혼동 행렬, 분류 보고서와 같은 지표를 사용하여 평가되었다. GridSearchCV를 적용하지 않은 모델의 정확도는 0.7, 0.875, 0.975인 반면, GridSearchCV를 적용한 모델의 정확도는 0.75, 1.0, 0.975로 나타났다. GridSearchCV는 로지스틱 회귀 분석을 세 가지 모델 중 약물 분류에 가장 효과적인 모델로 식별했으며, K-Nearest Neighbors가 그 뒤를 이었고 Na_to_K 비율은 결과를 예측하는 데 중요한 특징인 것으로 밝혀졌다.

• 한국임상약학회지
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• 제19권1호
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• pp.1-17
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• 2009

Adverse drug reactions (ADR) caused by inappropriate prescription are responsible for major socioeconomic loss. Drug-drug interactions (DDI) has been recognized as a major part of ADRs and, therefore, healthcare professionals should prevent possible DDIs to minimize preventable ADRs. This study aimed to examine DDI information in drug information references and Korea Food & Drug Administration (KFDA) drug labeling information. Drug ingredients from the formulary of Health Insurance Review and Assessment Service in Korea (HIRA) were included for the study. DDI information source used for the study were Micromedex Drugdex and Drug Information Facts (DIF) with the DDI severity level of "moderate" or more. The DDI information in KFDA drug labeling were collected and compared. Drug ingredients were classified with KFDA Drug Classification and ATC Classification of WHO for the analysis. Among the total 1,355 drug ingredients satisfying inclusion criteria, 738 ingredients involved at least one DDI, which was described in Micromedex and/or DIF. Drug Ingredients of 176 involved DDI only described in KFDA drug labeling, but not Micromedex nor DIF. Drug ingredients of 35 which DDIs were described in Micromedex or DIF did not have DDI based on KFDA drug labeling. Micromedex and DIF retrieved 7,582 and 3,071 DDIs, respectively 57.6% and 58.5% of DDIs were also described in KFDA drug labeling. Central nervous system (CNS) drugs, cardiovascular system (CVS) drugs and the antiinfectives appeared to have higher frequency of DDIs among all drug classes. The highest number of DDIs with high severity level ("contraindicated" or "major") were the DDIs of CNS drugs. The antiinfectives are the second drug group having serious DDIs. The DDI pairs of the CNS drug and the antiinfective had the highest contraindication risk (13.6%). DDI information from Micromedex and DIF were not consistent with the result that only 465 ingredients' DDIs are common in both literature (total DDI numbers were 715 vs 488, respectively). And 1,652 DDI information are common in both references among 7,582 vs 3,071 DDIs, respectively. Only 55.2% of DDI information in the database contained in the KFDA drug labeling. Prescribers and pharmacists should pay attention to the drugs for CV system, CNS and infections because of higher risk of possible DDIs compared to other drug classes. KFDA drug labeling is not likely to be recommended as a good information source for DDI due to significant inconsistency of information. Drug information providers should be aware that DDI information from different sources are not consistent and therefore multiple references should be used.

• Clinical and Experimental Pediatrics
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• 제63권6호
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• pp.203-210
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• 2020

The drug allergy "label" may have a lifetime of consequences for a child. Many children with alleged drug allergies are proven to be tolerant to the culprit medication when challenged. The field of drug hypersensitivity is a recently evolving field of research, but studies on its epidemiology and diagnostic tools are lacking in children. Clinical history is significant in the diagnosis and classification of drug hypersensitivity in children. Diagnostic tools have been evaluated in a limited number of children; therefore, the guidelines are mainly in line with those for adults. Here, we review the clinical characteristics, main drugs, risk factors, and diagnosis of drug hypersensitivity to aid in its accurate diagnosis in children.

• Journal of Pharmaceutical Investigation
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• 제36권3호
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• pp.161-167
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• 2006

The objective of this study was to investigate the dissolution patterns of variety of orally administered drug products available on the market. It aimed to understand their dissolution behaviors on the basis of the biopharmaceutics classification system (BCS) concept. On the tenets of BCS, several active pharmaceutical ingredients were selected: fluoxetine hydrochloride (class I), naproxen sodium (class ll), pyridostigmine bromide (class III), furosemide (class IV) and simvastatin (class IV). Typical dissolution media used in this study were pH 1.2, pH 4 & 6.8 phosphate buffers, and water. In cases, particular dissolution media specified in the KP and/or USP were used. Dissolution patterns of fluoxetine hydrochloride and pyridostigmine bromide products were characterized by their rapid release In addition, their dissolution characteristics were relatively unaffected by the type of a dissolution medium. Similar dissolution patterns were observed with pH 1.2, pH 4 & 6.8 phosphate buffers and water. By sharp contrast, poor dissolution patterns were noticed with naproxen sodium products, when pH 1.2 and pH 4 phosphate buffer were used. Improvements in its dissolution were achieved by switching the dissolution media to pH 6.8 phosphate buffer or water. Unsatisfactory dissolution data also were observed with a simvastatin product, when it was subject to dissolution tests by use of a surfactant-free pH 1.2, pH 4 & 6.8 phosphate buffers and water. All the release patterns reported in this study were best understood when BCS concepts were implemented. Our results demonstrated that a BCS-based drug classification should be considered first to choose a dissolution test/method and set up dissolution specification.

• The Journal of Korean Physical Therapy
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• 제13권3호
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• pp.719-726
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• 2001

Transdermal drug delivery offers various advantages over conventional drug delivery systems, such as avoidance gastrointestinal degradation and hepatic first-pass effect. encourages patient compliance. and possible sustained release of drugs. However, transdermal transport of drugs is low permeability of the stratum corneum, the superficial layer of the skin. Many physicochemical and biological factors influencing transdermal transport is described together with the corresponding experimental and clinical results. Phonophoresis is medical treatment with drugs introduced into the skin by ultrasound energy. Enhanced drug penetration is through to result from the biophysical alterations of skin structure by ultrasound waves. The frequency used for phonophoresis is usually from 20 kHz to 15MHz. Phonophoresis can be categorized in to three ranges: low-frequency range(below 1 MHz). therapeutic frequency range(1 to 3MHz), and high-frequency range(above 3 MHz). The depth of penetration of ultrasound into skin is inversely proportional to the frequency. Cavitation may cause mechanical stress. temperature elevation, or enhanced chemical reactivity causing drug transport. One theory is that ultrasound affects the permeation of the stratum corneum lipid structure as the limiting step in permeating through the skin. The range of indications for phonophoresis is wide. Aspecific classification of the range of indications is obtained by classification of pathological conditions. The continuous research is needed for many interesting issucs of phonophoretic transdermal delivory in new future.

• 생물정신의학
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• 제7권1호
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• pp.3-13
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• 2000

There is nothing that is harmless ; the dose alone decides that something is no poison(Paracelsus, 1493-1541). So, in a point of view to maximize the therapeutic efficacy of drug therapy in a way that minimize the drug toxicity, the knowledges of the drug-ineractions as well as the pharmacokinetic and pharmacodynamic principles of every therapeutic drug used in the medical clinic cannot be emphasized too much. Many drug interactions can be predicted if the pharmacokinetic properties, pharmacodynamic mechanisms of action of the interacting drugs are known, and most adverse interactions can be avoided. In this paper, the clinical importance, classification, and general principles of clinical drug-interactions are presentated with a few explanatory examples.

• 대한한의학회지
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• 제31권3호
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• pp.128-132
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• 2010

Objectives: This study aimed to review the general features of drug induced liver injury (DILI) and the important factors in consideration of herbal drugs and DILI. Methods: We reviewed general aspects of DILI such as classification, inducible factors, diagnosis methods, prevention, and the status of herbal drug-associated DILI via literature. Results: Besides the drug itself, genetic and environmental factors affect hepatic toxicity. There is a lack of definitive diagnoses of DILI by drugs, including herbal remedies. The possibility of herbal drug-associated DILI is exaggerated, and majority of herbal drug-derived hepatic injury could be easily prevented if Oriental doctors pay attention to this issue. Conclusion: This study can provide Oriental doctors an overview and be helpful in minimizing the episodes of hepatotoxicity in use of herbal drugs.