• 수산해양교육연구
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• 제29권2호
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• pp.581-585
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• 2017

To strengthen the quality control of aquatic drugs, we compared the internal and external(EU, USA and Japan) aquatic drug classification systems and proposed a new aquatic drug classification system. Aquatic drugs are classified on the basis of their functional the functional characteristics or safety management degree of aquatic drugs. We suggested that the aquatic drugs can be categorized into 7 levels according to their functional characteristics and classified into 3 levels according to the safety management degree of aquatic drugs.

• 약학회지
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• 제56권2호
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• pp.126-135
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• 2012

Purpose: To develop therapeutic duplication criteria for the drugs used for respiratory diseases. Method: Therapeutic duplication was defined as "more than 2 drug ingredient-usage in which each has the same therapeutic effect and combination therapy does not confer additional therapeutic benefit". Respiratory system drugs approved in Korea were examined for the study. The WHO's Anatomical Therapeutic Chemical Classification System was used for grouping of the corresponding drug ingredients. The principles and recommendations on combination usage or multiple drug regimens were reviewed by using the clinical practice guidelines, textbooks, product labelings, and clinical articles. Clinical expert group consultation was performed and expert opinions were incorporated into the final criteria. Results: Nine hundred sixty two drug products with Korean Food and Drug Administration classification codes of 141, 149, 222, and 229 were evaluated, of which 87 active ingredients were composed. The drug ingredients were classified into 12 groups (antihistamines, oral nasal decongestants, leukotriene receptor antagonists, inhaled anticholinergics, inhaled corticosteroids, oral ${\beta}2$-agonists, long-acting ${\beta}2$-agonists, short-acting ${\beta}2$-agonists, xanthines, antiallergics, mucolytics and cough suppressants). The use of more than 2 drug ingredients including the same group was therapeutic duplication, and thus combination should be recommended not to be used. Conclusion: Twelve drug groups were identified as therapeutic duplication criteria. Combination therapy within each group should not be used otherwise therapeutic benefits outweigh potential risks.

• 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.

• 한국식품위생안전성학회지
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• 제21권1호
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• pp.1-8
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• 2006

본 연구는 식품첨가물공전, 식품공전 및 Codex 에서의 첨가물관리현황을 비교 분석하여 첨가물공전 체계의 개선방향을 제시함으로서 국제적으로 조화가능한 과학적 및 체계적 기준 규격을 수립할 수 있도록 하기위해 착수되었다. 그 결과를 요약하면 국내에서의 식품의 분류 및 명칭을 Codex 식품분류체계와 비교, 검토한 후 우리나라 전통식품의 첨가물 사용과 관련하여 Codex 식품분류에 포함될 수 있도록 모색하였다. 식품공전에 있는 식품들을 검색한 결과 한과류, 엿류, 두부류와 묵류, 식용유지류, 다류, 조미식품, 김치전임식품, 인삼 및 홍삼제품의 8개 식품군에 속하는 식품들의 분류, 정의, 명칭, 첨가물 사용여부를 감안하여 Codex 기준과 조화시키기 위한 개별적인 개선방안을 제시하였다.

• 한국임상약학회지
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• 제15권2호
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• pp.127-138
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• 2005

This is to examine the OTC regulatory system of Korea in comparison with those of Japan, UK and US, and suggest the possible regulatory actions to harmonize it to international standards. Individual countries have their own regulatory requirements and processes far OTC application based on established drug monographs and safety profiles from clinical experiences. Categories of OTC drug monographs are being expanded with transparent establishment procedure according to detailed guidelines, and public opinions as well as professional experts for assessing appropriateness of wide usage without physician's prescription. In line with trend of self-medication worldwide, the number of OTC drugs is increasing and more efficient and professional drug review is underway in the separate OTC division in regulatory agency. For improving OTC regulatory system in Korea, settlement of optimal drug classification policy and management for encouraging OTC drug use, development of more detailed and specific guidelines for OTC drug application, expansion of OTC drug monographs, transparent process for OTC monographs establishment, and establishment of OTC division in health authority, are suggested.

• Journal of Pharmaceutical Investigation
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• 제38권3호
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• pp.183-189
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• 2008

The present study compared the feasibility of Caco-2 and MDCK cells as an efficient in-vitro model for the drug classification based on Biopharmaceutics Classification System (BCS) as well as an in-vitro model for drug interactions mediated by P-gp inhibition or P-gp induction. Thirteen model drugs were selected to cover BCS Class I{\sim}IV$ and their membrane permeability values were evaluated in both Caco-2 and MDCK cells. P-gp inhibition studies were conducted by using vinblastine and verapamil in MDCK cells. P-gp induction studies were also performed in MDCK cells using rifampin and the P-gp expression level was determined by western blot analysis. Compared to Caco-2 cells, MDCK cells required shorter period of time to culture cells before running the transport study. Both Caco-2 and MDCK cells exhibited the same rank order relationship between in-vitro permeability values and human permeability values of all tested model compounds, implying that those in-vitro models may be useful in the prediction of human permeability (rank order) of new chemical entities at the early drug discovery stage. However, in the case of BCS drug classification, Caco-2 cells appeared to be more suitable than MDCK cells. P-gp induction by rifampin was negligible in MDCK-cells while MDCK cells appeared to be feasible for P-gp inhibition studies. Taken all together, the present study suggests that Caco-2 cells might be more applicable to the BCS drug classification than MDCK-cells, although MDCK cells may provide some advantage in terms of capacity and speed in early ADME screening process.

• 한국임상약학회지
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• 제23권2호
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• pp.114-122
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• 2013

Background: Drugs should be evaluated in appropriate subjects representing potential population to take the drugs. This study focuses on gender factor and aims to make known the appropriateness of considering gender difference on clinical evaluation of drug with domestic data related to drug use. Methods: To understand gender difference shown in drug use, three types of domestic statistical data (prevalence of chronic disease, number of outpatient with major concerning disease, and consumption of medicine) were analyzed and compared according to gender. Results: Three of fifteen chronic diseases which were analyzed, showed significantly higher prevalence in women than in men, and three were vice versa. Meanwhile, the sex ratio of outpatients was significantly different in 22 major concerning diseases. Among the drug groups coded by Anatomical Therapeutic Chemical (ATC) Classification System, the consumption of most drug groups was generally higher in women than in men except for one group coded G (genito-urinary system and sex hormones). Conclusion: Gender difference should be considered in domestic clinical evaluation of drug and domestic guidance for reflecting gender difference should be established.

• 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.

• Natural Product Sciences
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• 제25권3호
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• pp.275-283
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• 2019

In this study, we described the new developed method to simultaneously discriminate two herbal drugs of Artemisiae Argyi Folium and Artemisiae Iwayomogii Herba using eight marker compounds (1 - 8) on an HPLC-PDA system. The developed method was applied to quantify the major components of two herbal drugs. The pattern analysis successfully discriminated and evaluated different components between Artemisiae Argyi Folium and Artemisiae Iwayomogii Herba. Results were used for classification of different species from collected samples.

• 한국임상약학회지
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• 제20권3호
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• pp.262-267
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• 2010

Therapeutic duplication of prescriptions is the most frequently reported inappropriate drug use in Korea. To prevent significant problems during drug prescribing and dispensing, prospectively, development of standard including drug lists considered as therapeutic duplications for the prioritized drug classes first would be necessary. This study was aimed to analyze frequent drug classes of therapeutic duplications by healthcare providers in clinical practice settings. National health claims data for drug review and reimbursement (1,426,065 prescriptions dated March 19, 2008) were analyzed. Therapeutic duplication was defined as the prescription including more than 2 ingredients belonging to the same KFDA drug classification numbers that considered to have therapeutic similarities. The following 3 drug classes were mostly frequent therapeutic duplication classes: 114 anti-pyretics, analgesics and anti-inflammatory drugs; 117 drugs for psycho-nervous system; 141 Antihistamines. About 3.5% of overall prescriptions analyzed showed therapeutic duplications. This result might be starting step to develop DUR therapeutic duplication standard.