약물 부작용, 오남용 방지를 위한 의약품 정보 어플리케이션 디자인 분석 및 제언 -‘약학정보원’ 어플리케이션 중심으로-

이원회(Lee, Won Hoe),송지성(Song, Ji Sung) 한국디자인문화학회 2020 한국디자인문화학회지 Vol.26 No.3

‘안전상비의약품’의 판매 이후 약물 복용에 대한 통제의 어려움과 약물 부작용, 오남용의 문제가 늘어가고 있는 현실에서 본 연구는 이를 해결하기 위한 의약품의 효율적인 구매와 안전한 복약, 정확한 정보 전달을 위한 ‘약학정보원’의 UI/UX 어플리케이션 디자인 방안을 제시하는 것을 목적으로 한다. 연구범위는 IOS, 안드로이드 환경의 5가지 국내 의약품 어플리케이션을 선정, 디자인과 사용자경험, 목표 약품에 대한 검색 및 검색결과에 대한 UI/UX 항목이다. 연구 방법으로는 실증 사례분석과 제이콥 닐슨(Jakob Nielsen)의 ‘사용성 평가’, 사용자동향 평가 방식을 활용하였다. 그중 의약품 어플리케이션의 주요 기능인 의약품검색-결과에 대한 반응 효과를 이용하였다. 연구결과는 다음과 같다. 의약품 어플리케이션은 가시성, 직관성, 정확성, 일관성이 중요한 요소임을 알 수 있었고 대부분의 어플리케이션이 소비자의 복용 약 이력을 관리하는 회원체계가 부족했으며, 주 기능인 의약품검색에서 약품명을 모르는 사용자를 위한 이미지검색 기능 디자인이 부족했다. 또한 대부분이 푸른색–무채색의 컬러를 사용하고 있음을 알 수 있다. ‘약학정보원’에서의 미흡한 점은 아이콘의 디자인적 결함, 내비게이션 바의 미흡(가시성 부족), 에러 창의 부재, 주 사용메뉴 등록기능 부재(효율성 부족), Main Page의 불필요한 요소 사용(심미성 부족), 페이지 전환 버튼의 미흡, 사용 가이드의 부재가 있다. 이로 인한 디자인 방향 제언은 첫째, 이해성이 높고 통일감 있는 시각적 아이콘의 리디자인이 필요하다. 둘째, 약제검색 페이지에서의 다양하고 통일된 검색기능을 이용하여 사용자의 편의를 도와야 한다. 추가로 인공지능의 딥러닝 기술을 이용한 ‘사진검색’ 기능을 추가하기를 제언한다. 셋째, 약제설명 페이지에서 정보 제공과 동시에 페이지 레이아웃에 집중하여 가독성을 높여야 한다. 넷째, 복약지도에 있어, 가독성을 위한 ‘인포그래픽’ 사용을 제안한다. 다섯째, 사용자의 복약 이력 관리가 가능한 회원체계로 변경해야 한다. 본 연구를 통해 사용자의 안전한 의약품 복용 생활에 도움을 주는 것에 본 논문의 의의가 있다. Pharmaceuticals are an important medium for maintaining the health and wellbeing for mankind. However, inappropriate administration and knowledge may result in risk of adverse reaction. As there are now ‘Safety Emergency Drugs’ sold outside the pharmacy for convenience of the consumers, it is difficult to control the drug administration, which is leading to more issues of adverse drug reaction and drug abuse. The purpose of this study is to provide the UI and UX design method to ‘Korea Pharmaceutical Information Center’ for efficient purchase of the drugs, safe administration and accurate delivery of information by using the application with good accessibility for the consumer to reduce the adverse drug reaction and drug abuse. For the scope of this study, 5 Korean pharmaceutical applications in IOS and Android environment were selected, and the design, user experience, search on target drug, and UI and UX items on the search results are included. Empirical case analysis, ‘Usability Evaluation’ by Jakob Nielsen and trend evaluation method were used as the study method. Among these methods, the reaction effect on drug search-result which is the main function of the pharmaceutical application was used. The results of this study are shown as follows. It was verified that the significant factors of pharmaceutical application were visibility, accuracy and consistency, and most of the applications lacked the membership system of managing the history of drugs administered by the consumers. In addition, the main function of drug search lacked the design on the image search function for users that do not know the drug name. Moreover, most of the applications were using blue-achromatic color. Insufficient matters in the ‘Korea Pharmaceutical Information Center’ included design fault on the icon, absence of navigation bar (poor visibility), error window and frequent menu registration function (poor efficiency), use of unnecessary elements on the main page (poor aesthetic impression), poor page conversion button and absence of use guide. Regarding the suggestion on the design direction, first, the re-design of an icon that is visible, highly understandable and with unity is required. Second, various search functions shall be used on the drug search page to support the convenience of the users. Additionally, the use of AI deep learning technology to add the ‘Image Search’ function is suggested. Third, the drug description page shall provide not only the information on the drug, but also be focused on the page layout to enhance the legibility. Fourth, the use of ‘Infographic’ is suggested for legibility on the medication counseling. Fifth, the application shall be changed to the membership system to enable mediation history management of the users. The significance of this study is to help the safe administration of drugs by the users.

희귀의약품 지정에 대한 법정책적 연구

정다영 동국대학교 비교법문화연구소 2023 比較法硏究 Vol.23 No.1

In Korea, the designation of rare diseases and orphan drugs in Korea is based on the rarity of the disease and the benefit of the drug. With advances in diagnostic technology, activation of health check-ups and an increase in the elderly population, the number of rare diseases is expected to increase. Government policies and regulations concerning orphan drugs have a significant impact on their development and distribution. The designation of orphan drugs is important not only for patients and their families, but also for national finances and the entry of pharmaceutical companies into orphan drug development. Therefore, the formulation of regulatory policies should be carefully considered in terms of improving access for rare disease patients, providing incentives for orphan drug development, and allocating scarce resources. To maximize the benefits of orphan drug regulation, it is necessary to raise awareness of the benefits of orphan drugs and to increase investment in the development of orphan drugs, thereby promoting the growth of the orphan drug market. Designation of orphan drugs should consider both the rarity and severity of the disease, as well as the potential marketability of the drug. In some cases, it may be appropriate to de-designate orphan drugs based on a cost-benefit analysis. Overall, a balanced approach is needed to ensure that orphan drugs are available to those who need them while maintaining fiscal responsibility. 우리나라는 희귀질환 및 희귀의약품의 지정기준을 질환의 희귀성과 의약품의 편익을 중심으로 판단하고 있다. 앞으로 진단기술의 발전과 건강검진의 활성화 및 고령 인구의 증가 등의 요인으로 인하여 희귀질환은 더욱 늘어날 것으로 판단된다. 희귀의약품의 지정은 환자 및 그 가족에게뿐 아니라 국가 재정의 측면 및 제약회사의 희귀의약품 개발에의 진입 측면에서도 매우 첨예한 부분으로서, 희귀의약품에 대한 정부 정책 및 규정은 희귀의약품 개발 및 유통에 영향을 미친다. 따라서 희귀질환과 희귀의약품의 지정 및 해제와 관련된 법정책을 수립함에 있어서는 희귀질환자의 접근성 강화, 희귀의약품의 개발 유인 제공 뿐 아니라 한정적인 자원의 분배 측면 또한 고려하여 신중하게 판단하여야 한다. 희귀의약품 규정의 잠재력을 활용하기 위해서는 희귀의약품의 혜택에 대한 인식의 제고와 희귀의약품 개발에 대한 투자의 증가를 유도함으로써 희귀의약품 시장의 성장을 꾀하여야 할 것이다. 이러한 점에서 희귀의약품의 지정에 있어서는 질환의 희귀성 뿐 아니라 심각성도 고려하고, 희귀의약품의 편익 뿐 아니라 의약품의 시장성 또한 고려하는 것이 바람직하다. 또한 경우에 따라서는 비용·편익 분석에 따라 희귀의약품의 지정 해제 가능성을 열어두는 것이 타당하다.

Role of computer-aided drug design in modern drug discovery

Stephani Joy Y. Macalino,홍선혜,GOSUVIJAYAKUMAR,최선 대한약학회 2015 Archives of Pharmacal Research Vol.38 No.9

Drug discovery utilizes chemical biology andcomputational drug design approaches for the efficientidentification and optimization of lead compounds. Chemical biology is mostly involved in the elucidation ofthe biological function of a target and the mechanism ofaction of a chemical modulator. On the other hand, computer-aided drug design makes use of the structuralknowledge of either the target (structure-based) or knownligands with bioactivity (ligand-based) to facilitate thedetermination of promising candidate drugs. Various virtualscreening techniques are now being used by bothpharmaceutical companies and academic research groupsto reduce the cost and time required for the discovery of apotent drug. Despite the rapid advances in these methods,continuous improvements are critical for future drug discoverytools. Advantages presented by structure-based andligand-based drug design suggest that their complementaryuse, as well as their integration with experimental routines,has a powerful impact on rational drug design. In thisarticle, we give an overview of the current computationaldrug design and their application in integrated rational drugdevelopment to aid in the progress of drug discoveryresearch.

Study of interactive Packaging Design Elements in Terms of Sustainability--Focusing on Faller Smart Drug Packing

席雨彤(Yutong XI) Korea Institute for Humanities and Social Sciences 2024 Journal of Global Arts Studies (JGAS) Vol.2 No.1

【背景】交互式设计概念应用于多个不同的领域, 使消费者与设计能够更好地交流;同时,其“用户导向”的设计理念也与“以人为本”的现代可持续理念相吻合。 【目的】研究者通过讨论交互式设计与可持续理念的关联性,阐述相关设计方法,旨在研究并推导出符合现代要求的具有可持续概念的交互式包装设计要素模型。 【方法】本研究针对可持续概念的应用路径,以交互式设计包装为对象,讨论相关设计方法,通过围绕包装与用户、包装与产品、包装与环境的交互式先行理论,分析德国包装设计公司“福勒”推出的智能药品包装。 【结果】本研究以具体的案例分析为基础,在可持续层面提出了交互式包装设计要素模型,包括感官要素、视觉要素、行为要素、结构要素和材料选择。 【结论】本研究在案例分析的基础上总结出了符合可持续理念的交互式包装设计要素模型,探讨了如何提高可持续交互包装设计的质量,以期在此基础上为今后的交互式包装设计相关研究提供理论上的参考依据。 [Background] The concept of interactive design is applied in many different fields, which enables consumers to communicate better with design. At the same time, its “user-oriented” design concept is also consistent with the “people-oriented” modern sustainable concept. [Objective]By discussing the relationship between interactive design and sustainable concepts, the researchers elaborated the relevant design methods, aiming to study and deduce the interactive packaging design element model with the sustainable concept that meets modern requirements. [Method] Aiming at the application path of the concept of sustainability, this study took the interactive design of the packaging as the object, discussed the relevant design methods, and analyzed the intelligent drug packaging launched by the German packaging design company “Faller” through the interactive advance theory around packaging and users, packaging and products, packaging and environment. [Results] Based on the analysis of specific cases, this study put forward an interactive packaging design element model at the sustainable level, including sensory elements, visual elements, behavioral elements, structural elements, and material selection. [Conclusion] Based on the case study, this study summed up the elements model of interactive packaging design that accords with the concept of sustainability and discussed how to improve the quality of sustainable interactive

일반 의약품 오·남용 방지를 위한 패키지 디자인 연구 - 위장약, 파스류를 중심으로 -

이경수 한국브랜드디자인학회 2012 브랜드디자인학연구 Vol.10 No.4

일반의약품은 소비자가 신문, 잡지, TV, 라디오 등의 광고를 보고 일반슈퍼 및 약국에서 자유구매 및 지정구매 할 수 있다. 이러한 연유로 일반소비자의 자가 진단 및 일반의약품 지정 구매에 따른 약물 오·남용이 심각하게 증대되고 있다. 우리나라의 경우 2012년 11월 15일 가정상비약 편의점 판매 시행하여 안전상비의약품으로 결정된 품목 해열진통제 5품목, 감기약 2품목, 소화제 4품목, 파스류 2품목 등 13개 품목이며, 일반의약품 중 안전성에 특별한 문제가 없는 일부를 편의점 등 소매점에서 쉽게 구매할 수 있도록 의약외품으로 전환한 연고제, 액상소화제, 정장제 등 외용제, 자양강장 드링크류 등 48품목 등은 소비자가 자유 구매가능하여 일반의약품 구입에 제한이 거의 없는 상황이고, 의약품분류기준의 한계로 인해 전문의약품에 가까운 약품들이 일반의약품으로 분류되어 있는 경우가 많은 것이 현실이다. 따라서 일반의약품의 패키지디자인은 효능·효과별 식별이 용이해야 되고, 용법·용량 및 주의사항 등의 정보를 정확하게 전달하여 일반의약품의 오·남용을 방지하여야 한다. 본 연구에서는 국내·외 일반의약품의 현황과 사례의 비교분석을 통하여 일반의약품 오·남용 방지를 위한 시각커뮤니케이션 방법으로 일러스트레이션(Illustration), 픽토그램(Pictogram), 다이어그램(Diagram), 카이(Khi), P.O.P(point of purchase) 등을 제시하였으며, 그 이용 범위를 일반의약품 패키지디자인에 한정하고 특히 일반의약품에 어떻게 계획되어야 효과적인 기능을 발휘하며, 역할을 다할 수 있는가를 연구하였다. Consumers can purchase necessary general drugs personally at a drugstore through advertisements in newspapers, magazines, TV and radio. For this reason, there is a serious increase in misuse and abuse of drugs among consumers due to self-diagnosis and personal purchase of general drugs. In Korea, one can purchase general drugs almost without limitation and a lot of drugs close to prescription drugs are in reality categorized into general drugs due to limitations of the standards for drug classification. Therefore, the package design for general drugs should enable easy identification by effectiveness and efficacy and deliver correct information on usage, dosage, and cautions in order to prevent misuse and abuse of general drugs. In the case of Korea, the reality is that if a lot of drugs to the nearest specialized drugs that are classified as generic medicines due to the limitations of the situation is not nearly limited to the purchase of generic medicines and drugs classification criteria. Therefore, the package design of generic drugs efficacy and identify the specific effects will be easy, Dosage and Precautions accurately convey the information of generic drugs abuse and misuse be prevented. After this comparative analysis of the actual conditions and cases of domestic and foreign general drugs, illustration, pictogram, diagram, khi, point of purchase (P.O.P) of visual communication to prevent misuse and abuse of general drugs; it is then considered how to set limits to the use in package design, particularly, for general drugs in order to enable them to act effectively and fulfill their role.

Self-Attention 기반의 변분 오토인코더를 활용한 신약 디자인

( Piao Shengmin ),최종환 ( Jonghwan Choi ),서상민 ( Sangmin Seo ),김경훈 ( Kyeonghun Kim ),박상현 ( Sanghyun Park ) 한국정보처리학회 2022 정보처리학회논문지. 소프트웨어 및 데이터 공학 Vol.11 No.1

신약 디자인은 단백질 수용체와 같은 생물학적 표적과 상호작용할 수 있는 약물 후보물질을 식별하는 과정이다. 전통적인 신약 디자인 연구는 약물 후보 물질 탐색과 약물 개발 단계로 구성되어 있으나, 하나의 신약을 개발하기 위해서는 10년 이상의 장시간이 요구된다. 이러한 기간을 단축하고 효율적으로 신약 후보 물질을 발굴하기 위하여 심층 학습 기반의 방법들이 연구되고 있다. 많은 심층학습 기반의 모델들은 SMILES 문자열로 표현된 화합물을 재귀신경망을 통해 학습 및 생성하고 있으나, 재귀신경망은 훈련시간이 길고 복잡한 분자식의 규칙을 학습시키기 어려운 단점이 있어서 개선의 여지가 남아있다. 본 연구에서는 self-attention과 variational autoencoder를 활용하여 SMILES 문자열을 생성하는 딥러닝 모델을 제안한다. 제안된 모델은 최신 신약 디자인 모델 대비 훈련 시간을 1/26로 단축하는 것뿐만 아니라 유효한 SMILES를 더 많이 생성하는 것을 확인하였다. De novo drug design is the process of developing new drugs that can interact with biological targets such as protein receptors. Traditional process of de novo drug design consists of drug candidate discovery and drug development, but it requires a long time of more than 10 years to develop a new drug. Deep learning-based methods are being studied to shorten this period and efficiently find chemical compounds for new drug candidates. Many existing deep learning-based drug design models utilize recurrent neural networks to generate a chemical entity represented by SMILES strings, but due to the disadvantages of the recurrent networks, such as slow training speed and poor understanding of complex molecular formula rules, there is room for improvement. To overcome these shortcomings, we propose a deep learning model for SMILES string generation using variational autoencoders with self-attention mechanism. Our proposed model decreased the training time by 1/26 compared to the latest drug design model, as well as generated valid SMILES more effectively.

의약품 설계 기반 품질 고도화(QbD)를 위한 QbD 6시그마 체계 구축에 관한 연구

김강희,김현정,Kim, Kang Hee,Kim, Hyun-jung 한국품질경영학회 2022 품질경영학회지 Vol.50 No.3

Purpose: This study proposes the application of Six Sigma management innovation method for more systematically enhanced execution of Quality by Design (QbD) activities. QbD requires a deeper understanding of the product and process at the design and development stage of the drug, and it is very important to ensure that no fault is fundamentally generated through thorough process control. Methods: Analyzing the background and specific procedures of quality improvement based on the drug design basis, and analyzing the key contents of each step, we have differentated and common points from the 6 Sigma methodology. We propose a new model of Six Sigma management innovation method suitable for pharmaceutical industry. Results: Regulatory agencies are demanding results from statistical analysis as a scientific basis in developing medicines to treat human life through quality improvement activities based on drug design. By utilizing the education system to improve the statistical analysis capacity in the Six Sigma activities and operating the 6 Sigma Belt system in conjunction, it helped systematically strengthen the execution power of quality improvement activities based on pharmaceutical design based on the members of the pharmaceutical industry. Conclusion: By using QbD Six Sigma, which combines quality enhancement based on pharmaceutical design basis and Six Sigma methodology suitable for pharmaceutical industry, it is possible to obtain satisfactory results both by pharmaceutical companies and regulators by using appropriate statistical analysis methods for preparing scientific evidence data required by regulatory.

2×3 이중 설계에서 생물학적 동등성 평가

우화형,정규진,박상규 한국데이터정보과학회 2017 한국데이터정보과학회지 Vol.28 No.4

Assessing bioequivalence between original drug and generic drug is traditionally based on 2×2 crossover design. As bioequivalence trials for highly variable drugs are getting popular, the required sample size based on 2×2 crossover design would be very large, which might cause the ethical concerns. Regulatory agencies like EMA and MFDS recommended higher order crossover designs such as 2×4, 4×2 and 4×4 crossover designs. Alternatively, a 2×3 dual design may be recommended in terms of economical and ethical points of view in comparison with the 2×4 crossover design for highly variable drug. In this study, we consider some statistical characteristics of 2×3 dual design and propose statistical procedures for calculating sample size and assessing bioequivalence based on 2×3 dual design. We also discuss the proposed procedures from the perspective of newly revised bioequivalence guidance issued by MFDS. 두 제제의 생체이용률을 비교하여 동등성을 입증하는 생물학적 동등성 시험은 표준 2×2 교차설계를 원칙으로 하고 있으나, 최근에는 제제의 특성이 고변동성으로 인해 표준 2×2 교차설계를 사용할 경우 지나치게 많은 피험자가 필요하게 되면서, EMA나 MFDS 등에서는 2×2 교차설계를 확장한 2×4, 4×2 또는 4×4 등의 고차원 설계를 권장하고 있다. 2×3 교차설계는 표준 2×2 교차설계에서 1기간을 확장한 설계로 불균형 설계이기는 하지만 2×4 교차설계와 비교해서 경제적, 윤리적 측면에서 장점을 갖고 있는 설계라 할 수 있다. 본 연구에서는 2×3 이중설계를 활용하는 생물학적 동등성 시험에서 설계의 통계적 특성을 고찰해 보고, 생물학적 동등성 평가를 위한 통계적 설계 및 추론 절차를 새롭게 개정된 의약품동등성시험기준을 적용하여 논의한다.

Sandwiched osmotic tablet for controlled release of metoprolol succinate

Aliasgar Kundawala,Parth Sheth,Deepak Maheshwari 한국약제학회 2016 Journal of Pharmaceutical Investigation Vol.46 No.1

In this study novel concept of osmotically controlled drug delivery system in the form of three layered sandwiched tablet (SOT) was introduced. The tablets were prepared and optimized by design of experiment method. Metoprolol succinate, an antihypertensive agent, was selected model drug. Modified Ishikawa diagram was used to understand critical parameters that might affect the final product. Sandwiched osmotic tablets were prepared by direct compression and coated with cellulose acetate film. The process and formulation parameters were initially screened by Plackett–Burman design and later optimized by Box Behnken design. From the tablets we evaluated hardness, friability, weight variation, weight gain, coating uniformity and in vitro drug release as critical quality attributes. The amount of sodium chloride, polyethylene oxide and hydroxypropyl methylcellulose were found to influence the drug release rate from SOT as evident from Plackett–Burman design. Further these factors were optimized to get extended drug release of 80 % or more in 20 h. Optimized formulation batches (BBD8 and BBD5) showed drug release of 79.62 ± 1.19 and 82.46 ± 0.45 % respectively in 20 h with diffusion controlled zero order drug release. The check point batch prepared showed drug release of 80.86 % in 20 h. The prepared osmotically controlled sandwiched tablet showed potential to control the drug release with zero order kinetics.

담당약사의 처방중재활동에 대한 약물유해반응 예방의 비교 분석

박태영,김윤희,정영미,이정화,이은숙 한국병원약사회 2014 병원약사회지 Vol.31 No.1

Background : It is well known that adverse drug events(ADEs) increase the length ofstay and charges in the hospital setting. Interventions by clinical pharmacists have been shown tobe a first step to prevent these medication errors and are associated with safe and effective pharmacotherapy. As an effort to increase appropriate interventions, Bundang Seoul National UniversityHospital(SNUBH) has designated clinical pharmacists who are in charge of medical intensive careunit(MICU), neonatal intensive care unit(NICU), surgical intensive care unit(SICU), geriatric carecenter(GC). and respiratory care center(RC). Interventions conducted are supposed to be recorded inelectronic medical records(EMR) and can be shared between pharmacists, which maximizes workefficiency. Objective : In order to measure the effect of designated-pharmacists on interventions, interventionsperformed by designated-pharmacists and non designated-pharmacists were analyzed. Methods : A retrospective database review of recorded clinical interventions by pharmacists wasconducted to classify interventions by types and an acceptance. One resident pharmacist(postgraduate year 1 or PGY1) and two clinical pharmacists not involved in the data collection valuateda prevention of ADEs. Cost avoidance was calculated to estimate the seriousness of ADEs andpotential extra cost in the absence of the intervention. Results : Five hundreds ninety interventions were documented during 1-month study period. The intervention rate by designated-pharmacists was 0.44%, which was higher than non designatedpharmacists by 0.32%. An acceptance rate by designated-pharmacists and non designatedpharmacistswas 76.1% and 68.5% respectively. Sixty three interventions were judged to haveprevented potential ADEs, of which thirty seven interventions had been conducted by designated-pharmacists. The estimated cost avoidance from interventions by designated-pharmacistswas approximately 10,030,000won and counts for 77% of total. Conclusions : In respect of the intervention rate, the acceptance rate, the prevention of ADEs,and the cost avoidance, designated-pharmacist policy has positive effect on pharmacotherapy.