• Title/Summary/Keyword: drug development

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Drug Safety Evaluation in the United States of America

  • Yoon, Young-H.;Johnson, Charles A.;Soltys, Randolph A.;Sibley, Peter L.
    • Korean Journal of Veterinary Pathology
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    • v.1 no.2
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    • pp.91-96
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    • 1997
  • General steps in the discovery and development of novel drugs in the United States are presented. The first step is the discovery of novel drugs. Brief histories and mechanisms of a few novel drugs in the American market are outlined. In this presentation preclinical animal toxicologic studies (drug safety evaluateion) are emphasized in regard to drug development. When preclinical animal studies have defined the toxicity and the doses at which it occurs an Investigational new Drug Application (IND) is submitted to the Food and Drug Administration (FDA) An IND notifies the FDA the intention to begin testing a novel drug in human subjects.

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Antioxidant Compounds Isolated from the Roots of Phlomis umbrosa Turcz.

  • Nguyen, Duc Hung;Le, Duc Dat;Zhao, Bing Tian;Ma, Eun Sook;Min, Byung Sun;Woo, Mi Hee
    • Natural Product Sciences
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    • v.24 no.2
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    • pp.119-124
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    • 2018
  • Two triterpenoids, arjunolic acid (1), belleric acid (2), five phenylethanoids, martynoside (3), orobanchoside (4), 3,4-dihydroxyphenethylalcohol-6-O-caffeoyl-${\beta}$-$\text\tiny{D}$-glucoside (5), leucosceptoside B (6), lunariifolioside (7), four phenolic acids, ferulic acid (8), syringic acid (9), vanillic acid (10), 4-hydroxybenzoic acid (11), and one lignan, (+)-syringaresinol-${\beta}$-$\text\tiny{D}$-glucoside (12), were isolated from the roots of P. umbrosa. All isolated compounds were explored for their antioxidant potential in the DPPH and ABTS assays. In DPPH assay, compound 5 showed high antioxidant capacity. Compounds 3, 4, 6, and 7 displayed considerable antioxidant activities. In addition, compounds 5-7 exhibited potential antioxidant capacities in the ABTS assay.

Consultation Program for Pharmaceutical Development-Lessons from Foreign Countries' Experiences (주요국의 의약품 사전상담제도 현황과 정책적 함의)

  • Park, Syl-Vi-A;Park, Eun-Ja;Han, Hyun-Jin
    • YAKHAK HOEJI
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    • v.52 no.2
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    • pp.151-159
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    • 2008
  • Consultation program for pharmaceutical development is a new system in which pharmaceutical companies meet and discuss scientific and/or regulatory issues with drug regulatory authority in the research process and before submitting new drug applications. This program helps pharmaceutical companies reduce uncertainties in the research and development and increase the possibilities of getting drug marketing approval. Developed countries such as US, EU, and Japan have implemented various forms of pre-submission meetings or consultation programs since the mid-1990s. The rapid development of technology in pharmaceutical R&D increases the importance of communication between drug development companies and drug regulatory authority in Korea, too. In designing the consultation program, it is desirable to focus on the stages of clinical trials which take the longest period of time and the biggest amount of money in the pharmaceutical R&D process. We suggested that results or recommendations by drug regulatory authorities in pre-submission meetings or consultations be formally documented and considered in review process. Explicit scientific reasons are required for changing the results from consultations.

Studies on the Synthesis and In Vitro Antitumor Activity of the Isoquinolone Derviatives

  • Cheon, Seung-Hoon;Lee, Joon-Yeol;Chung, Byung-Ho;Choi, Bo-Gil;Cho, Won-Jea;Kim, Tae-Sung
    • Archives of Pharmacal Research
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    • v.22 no.2
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    • pp.179-183
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    • 1999
  • 3-Arylisoquinolin-1(2H)-ones (2) are possible bioisosteres of the $5-[4^{l}-(piperidinomethyl)phenyl]-2<$,3-dihydroimidazo[2,1-$\alpha$]isoquinoline (1) which is in clinical evaluation for the treatment of cancer. Structure-activity relationship studies of 3-arylisoquinolin-1(2H)-ones. (2) led to the synthesis of 3-arylquinolin-2(1H)-ones (3). A number of 3-phenyl substituted quinolin-2(1H)-ones were synthesized and tested for their in vitro antitumor activity against four different human tumor cell lines and 3-phenyl-N-benzyl-3,4-dihydroquinolin-2(1H)-one (12) showed the most potent activity.

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A Study on the Intention to use the Artificial Intelligence-based Drug Discovery and Development System using TOE Framework and Value-based Adoption Model (TOE 프레임워크와 가치기반수용모형 기반의 인공지능 신약개발 시스템 활용의도에 관한 실증 연구)

  • Kim, Yeongdae;Lee, Won Suk;Jang, Sang-hyun;Shin, Yongtae
    • Journal of Information Technology Services
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    • v.20 no.3
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    • pp.41-56
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    • 2021
  • New drug discovery and development research enable clinical treatment that saves human life and improves the quality of life, but the possibility of success with new drugs is significantly low despite a long time of 14 to 16 years and a large investment of 2 to 3 trillion won in traditional methods. As artificial intelligence is expected to radically change the new drug development paradigm, artificial intelligence new drug discovery and development projects are underway in various forms of collaboration, such as joint research between global pharmaceutical companies and IT companies, and government-private consortiums. This study uses the TOE framework and the Value-based Adoption Model, and the technical, organizational, and environmental factors that should be considered for the acceptance of AI technology at the level of the new drug research organization are the value of artificial intelligence technology. By analyzing the explanatory power of the relationship between perception and intention to use, it is intended to derive practical implications. Therefore, in this work, we present a research model in which technical, organizational, and environmental factors affecting the introduction of artificial intelligence technologies are mediated by strategic value recognition that takes into account all factors of benefit and sacrifice. Empirical analysis shows that usefulness, technicality, and innovativeness have significantly affected the perceived value of AI drug development systems, and that social influence and technology support infrastructure have significant impact on AI Drug Discovery and Development systems.

The effect of drug holiday before tooth extraction on the development of medication-related osteonecrosis of the jaw in cancer patients receiving intravenous bisphosphonates

  • Cigdem Karaca;Goknur Topaloglu-Yasan;Selen Adiloglu;Ecem Usman
    • Journal of the Korean Association of Oral and Maxillofacial Surgeons
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    • v.49 no.2
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    • pp.68-74
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    • 2023
  • Objectives: Drug holidays are suggested to reduce the formation of osteonecrosis in patients under intravenous (IV) bisphosphonates (BPs) therapy. The objectives of this study are to evaluate the incidence of medication-related osteonecrosis of the jaw (MRONJ) following tooth extraction in cancer patients using IV BP, and to assess the effect of drug holiday on the development of MRONJ. Patients and Methods: A manuel search of the patient folders of Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Hacettepe University was undertaken to identify cancer patients who used IV BPs and had at least one tooth extraction between 2012 and 2022. Patents' age, sex, systemic condition, the type of BP used, duration of BP used, number of tooth extraction, duration of drug holiday, localization of tooth extraction and incidence of MRONJ were recorded. Results: One hundred nine teeth were removed from 57 jaws in 51 patients. All tooth extractions were performed under perioperative antibiotic prophylaxis and with primary wound closure. The incidence of MRONJ was 5.3%. Stage 1 MRONJ developed in 3 patients (only one had a drug holiday). The median duration of drug holiday was 2 months. No significant difference between the patients with and without a drug holiday and MRONJ development was found (P=0.315). The mean age of patients developed MRONJ was 40.33±8.08 years. A statistically significant difference was found between age and MRONJ development (P=0.002). Conclusion: The effect of a short-term drug holiday on the development of MRONJ may be limited because BPs remain in bone tissue for a long time. Drug holidays should be applied with the approval of an oncologist with other preventive measurements.

Pseudoreceptor: Concept and an Overview

  • Kothandan, Gugan;Madhavan, Thirumurthy;Gadhe, Changdev G.;Cho, Seung Joo
    • Journal of Integrative Natural Science
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    • v.3 no.3
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    • pp.162-167
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    • 2010
  • A pseudoreceptor combines structure-based and ligand-based techniques to represent a unifying concept for both receptor mapping and ligand matching. In this molecular modeling approach, there are opportunities to construct the pseudoreceptor models using a set of small molecules. To build a reliable pseudoreceptor model, we need a set of ligand molecules with known affinity (biological activity) to generate 3D bioactive conformation for each of these ligand molecules. Several software packages are available to generate a pseudoreceptor model and this can provide an entry point for structure based drug discovery in cases where receptor structure information is not available. In this review, we presented the concept of pseudoreceptor, as well as discussed about various software packages available to generate a pseudoreceptor model.

COVID-19 Drug Development

  • Kim, Seungtaek
    • Journal of Microbiology and Biotechnology
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    • v.32 no.1
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    • pp.1-5
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    • 2022
  • Diagnostics, vaccines, and drugs are indispensable tools and control measures employed to overcome infectious diseases such as coronavirus disease 2019 (COVID-19). Diagnostic tools based on RT-PCR were developed early in the COVID-19 pandemic and were urgently required for quarantine (testing, tracing and isolation). Vaccines such as mRNA vaccines and virus-vectored vaccines were also successfully developed using new platform technologies within one year after identifying severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) as the causative agent of COVID-19. Drug development has been conducted in various ways including drug repurposing, convalescent plasma therapy, and monoclonal antibody development. Among the above efforts, this review examines COVID-19 drug development along with the related and upcoming challenges.

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.