• Title/Summary/Keyword: New drug development process

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Applications of Genetically Modified Tools to Safety Assessment in Drug Development

  • Kay, Hee-Yeon;Wu, Hong-Min;Lee, Seo-In;Kim, Sang-Geon
    • Toxicological Research
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    • v.26 no.1
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    • pp.1-8
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    • 2010
  • The process of new drug development consists of several stages; after identifying potential candidate compounds, preclinical studies using animal models link the laboratory and human clinical trials. Among many steps in preclinical studies, toxicology and safety assessments contribute to identify potential adverse events and provide rationale for setting the initial doses in clinical trials. Gene modulation is one of the important tools of modern biology, and is commonly employed to examine the function of genes of interest. Advances in new drug development have been achieved by exploding information on target selection and validation using genetically modified animal models as well as those of cells. In this review, a recent trend of genetically modified methods is discussed with reference to safety assessments, and the exemplary applications of gene-modulating tools to the tests in new drug development were summarized.

A Study on the Prediction of Drug Efficacy by Using Molecular Structure (분자구조 유사도를 활용한 약물 효능 예측 알고리즘 연구)

  • Jeong, Hwayoung;Song, Changhyeon;Cho, Hyeyoun;Key, Jaehong
    • Journal of Biomedical Engineering Research
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    • v.43 no.4
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    • pp.230-240
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    • 2022
  • Drug regeneration technology is an efficient strategy than the existing new drug development process, which requires large costs and time by using drugs that have already been proven safe. In this study, we recognize the importance of the new drug regeneration aspect of new drug development and research in predicting functional similarities through the basic molecular structure that forms drugs. We test four string-based algorithms by using SMILES data and searching for their similarities. And by using the ATC codes, pair them with functional similarities, which we compare and validate to select the optimal model. We confirmed that the higher the molecular structure similarity, the higher the ATC code matching rate. We suggest the possibility of additional potency of random drugs, which can be predicted through data that give information on drugs with high molecular similarities. This model has the advantage of being a great combination with additional data, so we look forward to using this model in future research.

Rapid Analysis of Metabolic Stability and Structure of Metabolites in New Drug Development

  • Kim, Dong-Hyun
    • Proceedings of the PSK Conference
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    • 2002.10a
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    • pp.86-87
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    • 2002
  • Recent technological innovations in the drug discovery process such as combinatorial synthesis and high throughput screening have led to the identification of an increasingly large number of compounds at the hits-to-leads stage. Therefore, rapid and precise pharmacokinetic/metabolic screening is essential to enhance the tractability of selected leads and to minimize the risk of failure in the later stages of drug development. (omitted)

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Anti-malarial Drug Design by Targeting Apicoplasts: New Perspectives

  • Mukherjee, Avinaba;Sadhukhan, Gobinda Chandra
    • Journal of Pharmacopuncture
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    • v.19 no.1
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    • pp.7-15
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    • 2016
  • Objectives: Malaria has been a major global health problem in recent times with increasing mortality. Current treatment methods include parasiticidal drugs and vaccinations. However, resistance among malarial parasites to the existing drugs has emerged as a significant area of concern in anti-malarial drug design. Researchers are now desperately looking for new targets to develop anti-malarials drug which is more target specific. Malarial parasites harbor a plastid-like organelle known as the 'apicoplast', which is thought to provide an exciting new outlook for the development of drugs to be used against the parasite. This review elaborates on the current state of development of novel compounds targeted againstemerging malaria parasites. Methods: The apicoplast, originates by an endosymbiotic process, contains a range of metabolic pathways and housekeeping processes that differ from the host body and thereby presents ideal strategies for anti-malarial drug therapy. Drugs are designed by targeting the unique mechanism of the apicoplasts genetic machinery. Several anabolic and catabolic processes, like fatty acid, isopenetyl diphosphate and heme synthess in this organelle, have also been targeted by drugs. Results: Apicoplasts offer exciting opportunities for the development of malarial treatment specific drugs have been found to act by disrupting this organelle's function, which wouldimpede the survival of the parasite. Conclusion: Recent advanced drugs, their modes of action, and their advantages in the treatment of malaria by using apicoplasts as a target are discussed in this review which thought to be very useful in desigining anti-malarial drugs. Targetting the genetic machinery of apicoplast shows a great advantange regarding anti-malarial drug design. Critical knowledge of these new drugs would give a healthier understanding for deciphering the mechanism of action of anti-malarial drugs when targeting apicoplasts to overcome drug resistance.

Tutorial on Drug Development for Central Nervous System

  • Yoon, Hye-Jin;Kim, Jung-Su
    • Interdisciplinary Bio Central
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    • v.2 no.4
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    • pp.9.1-9.5
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    • 2010
  • Many neurodegenerative diseases, such as Alzheimer's and Parkinson's disease, are devastating disorders that affect millions of people worldwide. However, the number of therapeutic options remains severely limited with only symptomatic management therapies available. With the better understanding of the pathogenesis of neurodegenerative diseases, discovery efforts for disease-modifying drugs have increased dramatically in recent years. However, the process of translating basic science discovery into novel therapies is still lagging behind for various reasons. The task of finding new effective drugs targeting central nervous system (CNS) has unique challenges due to blood-brain barrier (BBB). Furthermore, the relatively slow progress of neurodegenerative disorders create another level of difficulty, as clinical trials must be carried out for an extended period of time. This review is intended to provide molecular and cell biologists with working knowledge and resources on CNS drug discovery and development.

Organizational Capabilities for Effective Knowledge Creation: An In-depth Case Analysis of Quinolone Antibacterial Drug Discovery Process (효과적 지식창출을 위한 조직능력 요건: 퀴놀론계 항생제 개발 사례를 중심으로)

  • Lee, Chun-Keun;Kim, Linsu
    • Knowledge Management Research
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    • v.2 no.1
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    • pp.109-132
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    • 2001
  • The purpose of this article is to develop a dynamic model of organizational capabilities and knowledge creation, and at the same time identify the organizational capability factors for effective knowledge creation, by empirically analyzing the history of new Quinolone antibacterial drug compound (LB20304a) discovery process at LG, as a case in point. Major findings of this study are as follows. First, in a science-based area such as drug development, the core of successful knowledge creation lies in creative combination of different bodies of scientific explicit knowledge. Second, the greater the difficulty of learning external knowledge, the more tacit knowledge is needed for the recipient firm to effectively exploit that knowledge. Third, in science-based sector such as pharmaceutical industry, the key for successful knowledge creation lies in the capability of recruiting and retaining star scientists. Finally, for effective knowledge creation, a firm must keep its balance among three dimensions of organizational capabilities: local, process, architectural capabilities.

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National Strategic Planning For Facilitating the Development of New Drugs in the Korea Food and Drug Administration (국내 신약개발 촉진을 위한 식약청의 국가연구개발 사업 전략수립)

  • Kim, Jong-Wook;Kwon, Kwang-Il;Yoo, Kwang-Soo;Park, So-Hyun;Lim, Chul-Joo;Choi, Don-Woong
    • Journal of the Korean Applied Science and Technology
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    • v.25 no.4
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    • pp.539-555
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    • 2008
  • It is well understood that developing new drugs is one of the highest value-added businesses in a country; however, the current governments' spending in pharmaceutical research and development(R&D) is minimal in Korea. This paper suggests that different governmental bodies should take in charge of different stages of the R&D process in order to maximize the use of limited government research funding. First, during the initial phase of the drug development, including clinical trials, the Ministry of Education, Science and Technology is the most appropriate governmental organization to support the research. For later procedures such as supporting the industries for exporting developed drugs, legislative approvals, and building infrastructure for future clinical trials should be supported by the Ministry of Knowledge and Economy and the Ministry of Health and Welfare along with the Korea Food and Drug Administration(KFDA). The KFDA, which is the main governmental agency approving newly developed drugs in the market, will need to take a crucial responsibility in the initial phase of the pharmaceutical R&D by guiding the industries with timely and proper information. As a first step, it is recommended to set up and operate a center for supporting new drugs, so that the industries can facilitate the development of marketable drugs which meet customers' needs. Later, in order to expedite the process of exporting and getting approvals of the newly developed drugs from foreign countries, it is necessary to develop new approval system, which includes introduction of the Good Manufacturing Practice (GMP), mandatory validation system, and education program for supporting expertise. Lastly, the KFDA needs to take an active role in developing Korean pharmaceutical industries by communicating with other foreign governments with regards to the globalization of the Korean pharmaceutical industries. For example, as a follow up after the Free Trade Agreement(FTA), active discussion on GLP of Mutual Recognition Agreement(MRA) with the United States of America, should be seriously considered.

Technical Trends in Artificial Intelligence for De Novo Drug Design (신규 약물 설계를 위한 인공지능 기술 동향)

  • Y.W. Han;H.Y. Jung;S.J. Park
    • Electronics and Telecommunications Trends
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    • v.38 no.3
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    • pp.38-46
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    • 2023
  • The value of living a long and healthy life without suffering has increased owing to aging populations, transition to welfare societies, and global interest in health deriving from the novel coronavirus disease pandemic. New drug development has gained attention as both a tool to improve the quality of life and high-value market, with blockbuster drugs potentially generating over 10 billion dollars in annual revenue. However, for newly discovered substances to be used as drugs, various properties must be verified over a long period in a time-consuming and costly process. Recently, the development of artificial intelligence technologies, such as deep and reinforcement learning, has led to significant changes in drug development by enabling the effective identification of drug candidates that satisfy desired properties. We explore and discuss trends in artificial intelligence for de novo drug design.

De Novo Drug Design Using Self-Attention Based Variational Autoencoder (Self-Attention 기반의 변분 오토인코더를 활용한 신약 디자인)

  • Piao, Shengmin;Choi, Jonghwan;Seo, Sangmin;Kim, Kyeonghun;Park, Sanghyun
    • KIPS Transactions on Software and Data Engineering
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    • v.11 no.1
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    • pp.11-18
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    • 2022
  • 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.

Development of Large Volume of Highly Viscoelastic Drug Infuser (대용량 고점탄성 약물 주입기 개발)

  • Bang, Jun Ho;Kwon, Soonwoo;Kang, Taewon
    • Journal of the Korean Society of Manufacturing Technology Engineers
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    • v.26 no.1
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    • pp.36-43
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    • 2017
  • A drug infuser is a well-known device that is widely used in various areas of clinical practice. However, some materials used in the drug infuser have been developed for particular purposes and thus, their design characteristics have to be changed considerably. Especially, the implications of a new filler in the drug infuser have migrated to the areas of body corrections in plastic surgery. In this study, the design process of a drug infuser managing a large content volume has been studied from the perspective of structure safety. A new design of the drug infuser that uses a 10 cc filler with high viscosity is presented. Finite element analysis is used to confirm that the assembled drug infuser is safe enough to hold the required loading of 490 N. Furthermore, the final prototype of the drug infuser was successful in reducing the weight up to 400 g without compromising the safety.