• 제목/요약/키워드: New drug development

검색결과 673건 처리시간 0.03초

광학이성질체 의약품의 안전성과 유효성 측면에서 의약품 허가신청 자료에 대한 비교연구 (Investigation of New Drug Submission Documents for the Safety and Efficacy Evaluation of Stereoisomeric Drugs)

  • 김광준;최인;이범규;문홍섭;한효경;최은주;이원재
    • 통합자연과학논문집
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    • 제4권4호
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    • pp.315-322
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    • 2011
  • This study was performed to investigate the current regulatory guidances of safety and efficacy evaluation for the approval of stereoisomeric drugs in Korea and US. According to the regulatory guidelines in major countries (EU, Canada, US), the important categories for the development of stereoisomeric drugs are classified as 1) development of a single enantiomer as a new active substances 2) development of a racemate as a new active substance 3) development of a new single enantiomer from an approved racemate. For this study, domestic regulatory documents for current guidelines of stereoisomeric drugs were investigated. Also four typical stereoisomeric drugs for three categories were chosen to investigate the new drug submission documents of KFDA and FDA for the safety and efficacy evaluation of stereoisomeric drugs. It is expected that these comparative results between KFDA and FDA will be useful for the safety and efficacy for the regulatory approval of stereoisomeric drugs in Korea.

Novel Cell-based Protease Assay System for Molecular Cell Biology and Drug Discovery

  • Hwang, Hyun-Jin;Kim, Jeong-Hee;Park, Joon-Woo;Kim, Sung-Hee;Lee, Min-Jeon;Jeong, Han-Seung;Hwang, In-Hwan
    • 대한약학회:학술대회논문집
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    • 대한약학회 2003년도 Proceedings of the Convention of the Pharmaceutical Society of Korea Vol.2-2
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    • pp.169.1-169.1
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    • 2003
  • Recently development of cell-based assay systems which are useful in molecular cell biology and drug discovery attracts significant attention. Here, we introduce a new technologies for monitoring enzyme activity and its inhibition inside living cells. Among various enzymes, proteases are important targets for studying various biological and disease-related processes such as viral infections, apoptosis and Alzheimer's disease. In this study, a sensitive cell-based protease detection system that enables direct fluorescence detection of a target protease and its inhibition inside living cells is introduced. (omitted)

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Long Non-coding RNAs and Drug Resistance

  • Pan, Jing-Jing;Xie, Xiao-Juan;Li, Xu;Chen, Wei
    • Asian Pacific Journal of Cancer Prevention
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    • 제16권18호
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    • pp.8067-8073
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    • 2016
  • Background: Long non-coding RNAs (lncRNAs) are emerging as key players in gene expression that govern cell developmental processes, and thus contributing to diseases, especially cancers. Many studies have suggested that aberrant expression of lncRNAs is responsible for drug resistance, a substantial obstacle for cancer therapy. Drug resistance not only results from individual variations in patients, but also from genetic and epigenetic differences in tumors. It is reported that drug resistance is tightly modulated by lncRNAs which change the stability and translation of mRNAs encoding factors involved in cell survival, proliferation, and drug metabolism. In this review, we summarize recent advances in research on lncRNAs associated with drug resistance and underlying molecular or cellular mechanisms, which may contribute helpful approaches for the development of new therapeutic strategies to overcome treatment failure.

Clinical Geriatric Pharmacology

  • Sohn, Dong-Ryul
    • 한국응용약물학회:학술대회논문집
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    • 한국응용약물학회 1997년도 추계학술대회
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    • pp.87-91
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    • 1997
  • The range of disorders of old age that are thought potentially amenable to drug therapy is increasing. However, factors such as the growing costs of drug development and prescription, the novel pharmacological profile and enhanced potency of many new compounds, and the concerns that the elderly may have enhanced susceptibility to toxicity all make drug usage in the elderly patient an increasingly specialized topic. This is compounded by the high incidence of multiple disorders in frail elderly patients, and consequently the possibility of the long term use of several drugs, thus, adding the risk of drug interactions. Thus, clinical pharmacology in the elderly requires understanding of pharmacologic characteristic determinants of the physiological changes (Table 1) associated with aging in terms of pharmacokinetics and pharmacodynamics.

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Detergent and Phospholipid Mixed Micelles as Proliposomes for an Intravenous Delivery of Water-Insoluble Drugs

  • Son, Kyong-Hee
    • Journal of Pharmaceutical Investigation
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    • 제22권3호spc1호
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    • pp.17-34
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    • 1992
  • A novel drug delivery system, detergent-phospholipid mixed micelles as proliposomes, for water-insoluble compounds was developed by investigating (i) spontaneous formation of small unilamellar vesicles (SUV) from bile salt-egg phosphatidylcholine mixed micelles, (ii) the molecular mechanism of micelle-to-vesicle transition in aqueous mixtures of detergent-phospholipid, (iii) preparation and screening of a suitable liposomal formulation for a lipophilic drug: solubilization of the drug within the lipid bilayer, evaluation of the solubility limit, and characterization of the resulting product with respect to the physical properties and stability of the drug in the system, and (iv) testing antitumor activity in vitro. The results showed that the new carrier had a strong possibility to be a biocompatible universal formulation for water-insoluble drugs.

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

  • 이춘근;김인수
    • 지식경영연구
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    • 제2권1호
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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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Homology Modeling of GPR18 Receptor, an Orphan G-protein-coupled Receptor

  • Kothandan, Gugan;Cho, Seung Joo
    • 통합자연과학논문집
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    • 제6권1호
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    • pp.16-20
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    • 2013
  • G-protein-coupled receptor (GPCR) superfamily is the largest known receptor family, characterized by seven transmembrane domains and considered to be an important drug target. In this study we focused on an orphan GPCR termed as GPR18. As there is no X-ray crystal structure has been reported for this receptor, we report on a homology model of GPR18. Template structure with high homology was used for modeling and ten models were developed. A model was selected and refined by energy minimization. The selected model was further validated using various parameters. Our results could be a starting point for further structure based drug design.

신약개발과 안전성약리시험 가이드라인 (Drug Development and Guideline for Safety Pharmacology Studies)

  • 최기환;박인숙;임화경;오우용;왕소영;김소희;김주일;김동섭
    • 약학회지
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    • 제47권2호
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    • pp.104-109
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    • 2003
  • The present paper reviews the notion and comparison of the Korea Food and Drug Administration(KFDA) general pharmacology and the International Conference on Harmonisation (ICH) safety pharmacology. General pharmacology or safety pharmacology is termed the study to determine the potential of a compound to induce adverse pharmacological effects. KFDA general pharmacology studies have been considered an important component in drug safety assessment and these were originally referred to those designed to examine effects other than the primary therapeutics effect of a drug candidate. The KFDA notified the Guideline for General Pharmacology in 1997. Safety pharmacology studies were focused on identifying adverse effects on physiological functions. In the ICH came into place S7A Safety Pharmacology Studies for Human Pharmaceuticals in 2001. A new chemical entity should be assessed for its side effects, initially in those physiological systems which are generally agreed to be the key systems that are essential for life; these "core system" include the central nervous system, cardiovascular system and respiratory system in safety pharmacology studies. These studies should be performed in compliance with Good Laboratory Practice (GLP).

Immunological Mechanisms in Cutaneous Adverse Drug Reactions

  • Ai-Young Lee
    • Biomolecules & Therapeutics
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    • 제32권1호
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    • pp.1-12
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    • 2024
  • Adverse drug reactions (ADRs) are an inherent aspect of drug use. While approximately 80% of ADRs are predictable, immune system-mediated ADRs, often unpredictable, are a noteworthy subset. Skin-related ADRs, in particular, are frequently unpredictable. However, the wide spectrum of skin manifestations poses a formidable diagnostic challenge. Comprehending the pathomechanisms underlying ADRs is essential for accurate diagnosis and effective management. The skin, being an active immune organ, plays a pivotal role in ADRs, although the precise cutaneous immunological mechanisms remain elusive. Fortunately, clinical manifestations of skin-related ADRs, irrespective of their severity, are frequently rooted in immunological processes. A comprehensive grasp of ADR morphology can aid in diagnosis. With the continuous development of new pharmaceuticals, it is noteworthy that certain drugs including immune checkpoint inhibitors have gained notoriety for their association with ADRs. This paper offers an overview of immunological mechanisms involved in cutaneous ADRs with a focus on clinical features and frequently implicated drugs.

한국산 흉상어과(Carcharhinidae) 어류 1미기록종, Carcharhinus obscurus (Lesueur, 1818) (First Reliable Record of the Dusky Shark Carcharhinus obscurus (Lesueur, 1818) (Carcharhinidae, Pisces) from Korea)

  • 이우준;김윤지;나정현;김진구
    • 한국수산과학회지
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    • 제52권6호
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    • pp.696-701
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    • 2019
  • Five specimens (839 - 1280 mm TL, Total length) of the dusky shark Carcharhinus obscurus, belonging to the family Carcharhinidae, were collected from the waters off Jejudo Island, Sinan, Namhae, Busan and Gangneung, Korea, during 2010-2019. Carcharhinus obscurus was similar to Carcharhinus brachyurus but was distinguished by the interdorsal ridge (present in C. obscurus vs. absent in C. brachyurus) and the shape of upper jaw teeth (broad in C. obscurus vs. narrow in C. brachyurus). In addition, 479 base-pair sequences in the mitochondrial DNA cytochrome c oxidase subunit I (COI) of our two specimens corresponded to those of C. obscurus (genetic distance, 0.000-0.003), but clearly distinguished from those of the Korean C. brachyurus (genetic distance, 0.03). We adopted the Korean name "Heuk-sang-eo" for Carcharhinus obscurus, after Kim and Ryu (2017).