• Title/Summary/Keyword: new drugs

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Establish data collection and management system for successful clinical trials of korean medicine (한의학의 성공적인 임상시험을 위한 데이터 수집 및 관리 체계 구축)

  • So, Ji-Ho;Jeon, Young-Ju
    • The Journal of the Convergence on Culture Technology
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    • v.4 no.4
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    • pp.387-392
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    • 2018
  • Clinical trials are an important part of developing new medical devices or developing new drugs. However, it takes many time and expense to conduct clinical trials. In order to solve this problem, it define the standard format of the data collected in clinical trials in major countries and in Korea. Clinical trials are also underway in korean medicine to develop new medical devices. If it define the standards for the data we collect in clinical trials, there are likely to be a variety of ways to use them. If it collect and manage various clinical trial data as one standardized data, you will be able to draw various results. Based on these findings, we established a system for collecting and managing integrated data on clinical trials. And let's look at how to use it.

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.

Comparative Study on the Regimens with Pyrazinamide or Ofloxacin in the retreatment of pulmonary tuberculosis (폐결핵 재치료에서 Pyrazinamide 복합처방과 Ofloxacin 복합처방의 효과에 관한 비교 연구)

  • Choi, In Hwan;Park, Seung Kyu;Kim, Kyeong Ho;Kim, Jin Ho;Kim, Cheon Tae;Song, Sun Dae
    • Tuberculosis and Respiratory Diseases
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    • v.43 no.6
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    • pp.871-881
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    • 1996
  • Objective: In the early short-term therapy of pulmonary tuberculosis, PZA is used for the first two months on 6EHRZ therapy but PZA is not effective in the case of long-tenn use PZA for retreatment in the sensitive relapse or acquired drug resistance for PZA. But in the endemic area as Korea, if we can't use PZA in the retreatment of pulmonary tuberculosis, we can't expect the success for retreatment of pulmonary tuberculosis, therefore we need new drugs substituting for PZA. In these days, 4 - fluoroquinolone derivatives were investigated and only ofloxacin and ciprofloxacin of derivatives were known to be effective but the effectiveness was also not certain because the result was experimental or combined with other bacteriocidal drugs and datas on effectiveness of pulmonary tuberculosis were so little. Therefore these drugs should be use with other two or three strong-acting drugs in the last period of retreatment of pulmonary tuberculosis. The ofloxacin or ciprofloxacin is used in some area in Korea but randomly and needed more study. We did this study for proving the effectiveness of these drugs and establishment of retreatment regimen for pulmonary tuberculosis. Methods: Retrospective cohort study of 83 drug-resistant pulmonary tuberculosis patients at National Masan Tuberculosis Hospital from Jan. 1994 to dec. 1995 was made. All the patients taken medicine for 2nd ami-tuberculosis regimens for the first lime. We separated the patients by two groups.(Group I : OFX+ PTA + CS+PAS + Injection, Group II: PZA + PTA+ CS + PAS + Injection). We compared the difference between two groups and tested the confidence limit about results after treatment by $\chi$2-test and T-test. Results : 1. The age distribution was most frequent in fourth decade(29.2% in Group I, 37.1% in Group II) and the mean age was 43.9 year in Group I, and 39.0 year in Group II, but had no significant difference between two groups. The sex distribution was more frequent in the males(68.8% in Group I, 85.7% in Group II), but had no significant difference. 2. Family history was 29.2% in Group I, 28.6% in Group II, but had no significant difference. 3. In the respect of extent of disease, far-advanced stare was 60.4% in Group I, 74.3% in Group II, but had no significant difference. 4. The side effects for drugs showed in 58.3% in Group I and 65.7% in Group II, and the gastrointestinal trouble showed 25.0% in Group and arthralgia 34.3% in Group II predominantly respectively and had the significant difference(p<0.05). 5. The negative conversion rate on sputum AFB smear was 87.5% in Group I and 80.0% in Group II, but had no significant difference. But the negative conversion rate on sputum AFB culture was 83.3% in Group I and 57.1 % in Group II and had the significant difference(p<0.05). 6. The success rate of treatment was 87.5 % in Group I and 83.3 % in Group II but had no significant difference. Conclusion : In the retreatment of pulmonary tuberculosis, ofloxacin is useful drug for the patients who are not available to use PZA and can be use effectively substituting for PZA.

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Legal Issues on the Development of New Drug: An Analysis of COVID-19 Vaccine (신약개발의 법적쟁점 - 코로나바이러스 감염증 백신을 중심으로 -)

  • Yi, Hyunjoo;Jeong, Jonggu;Kim, Hyein
    • The Korean Society of Law and Medicine
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    • v.21 no.3
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    • pp.37-75
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    • 2020
  • There have been affluent studies on the development of new drugs and these efforts have been crystallized into a separate field of pharmacology. Yet, a normative analysis pertinent to the development of new medicine is still in a dire need, except for studies regarding medical ethics. This piece of work aims to contemplate on the legal issues concerning the development of new drug, encompassing each and every stage of the development. In order to maximize the practicability of the research method adopted as aforementioned, this work strives to analyze the developing process of COVID-19 vaccine. The first step would be to introduce the developmental stages of inventing a new drug, especially that of a COVID-19 vaccine. After then, legal issues related to each developmental stage would be discussed. Henceforth, the legal analysis would contribute to predicting upcoming legal complexities and will be able to offer normative implications for the invention of new medicines.

Butyric acid and prospects for creation of new medicines based on its derivatives: a literature review

  • Lyudmila K. Gerunova;Taras V. Gerunov;Lydia G. P'yanova;Alexander V. Lavrenov;Anna V. Sedanova;Maria S. Delyagina;Yuri N. Fedorov;Natalia V. Kornienko;Yana O. Kryuchek;Anna A. Tarasenko
    • Journal of Veterinary Science
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    • v.25 no.2
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    • pp.23.1-23.15
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    • 2024
  • The widespread use of antimicrobials causes antibiotic resistance in bacteria. The use of butyric acid and its derivatives is an alternative tactic. This review summarizes the literature on the role of butyric acid in the body and provides further prospects for the clinical use of its derivatives and delivery methods to the animal body. Thus far, there is evidence confirming the vital role of butyric acid in the body and the effectiveness of its derivatives when used as animal medicines and growth stimulants. Butyric acid salts stimulate immunomodulatory activity by reducing microbial colonization of the intestine and suppressing inflammation. Extraintestinal effects occur against the background of hemoglobinopathy, hypercholesterolemia, insulin resistance, and cerebral ischemia. Butyric acid derivatives inhibit histone deacetylase. Aberrant histone deacetylase activity is associated with the development of certain types of cancer in humans. Feed additives containing butyric acid salts or tributyrin are used widely in animal husbandry. They improve the functional status of the intestine and accelerate animal growth and development. On the other hand, high concentrations of butyric acid stimulate the apoptosis of epithelial cells and disrupt the intestinal barrier function. This review highlights the biological activity and the mechanism of action of butyric acid, its salts, and esters, revealing their role in the treatment of various animal and human diseases. This paper also discussed the possibility of using butyric acid and its derivatives as surface modifiers of enterosorbents to obtain new drugs with bifunctional action.

A Clinical Effect of Ofloxacin, Prothionamide, Cycloserine Streptomycin(Kanamycin or Tuberactinomycin) in Retreatment of Pulmonary Tuberculosis (폐결핵 재치료에서 Ofloxacin, Prothionamide, Cycloserine, Streptomycin(Kanamycin or Tuberactinomycin) 4제요법의 임상 효과)

  • Song, Ju-Young;Yoo, Min-Kyu;Hong, Jae-Rack;Jeong, Jae-Man;Kim, Young-Jun;Kim, Moon-Shik
    • Tuberculosis and Respiratory Diseases
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    • v.42 no.3
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    • pp.295-301
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    • 1995
  • Background: The serious problems in retreatment of pulmonary tuberculosis are a significant proportion of drug resistance. Preferably retreatment should contain the drugs which has never used before, so drug retreatment is limited in selection. A new antibacterial substance, ofloxacin(OFX) is the activity against mycobacterium tuberculosis and it has been used in the treatment of pulmonary tuberculosis. The present report concerns the result of retreatment of pulmonary tuberculosis patients containing OFX treated at National Kongju Tuberculosis Hospital. Method: A retrospective study was made through the regular follow up of 92 smear positive cases, who were treated by four drugs regimen between Mar 1991 and June 1994 at National Kongju Tuberculosis Hospital. Four drugs were, namely prothionamide, cycloserine, ofloxacin and streptomycin(kanamycin or tuberactinomycin). The duration of follow up was over one year. Results: 1) Out of 92 cases with positive sputum AFB smear, 67(73%) achieved the negative conversion. 2) Considering the negative sputum conversion in all the groups, the vast majority(85%) of sputum conversion occurred within the first 4 months. 3) The roentgenological improvement occurred in 49 percent on the whole and when the extent of disease was minimal, moderately, far advanced pulmonary tuberculosis, sputum AFB smear negative response to retreatment was 100%, 93%, 68%, respectively. 4) When the duration of patient's illness was less than 1 year, 1 to 3 years, 3 to 5 years and more than 5 years, sputum AFB smear negative response to retreatment was 87%, 76%, 65% and 55%, respectively. 5) Adverse reaction to prothionamide, with complaints of gastrointestinal troubles was common and hepatic dysfunction without jaundice was observed in 7 percent, convulsion in 1 percent, that to cycloserine occurred renal dysfunction & psycosis & convulsion, 2%, 1%, 1%, respectively. Tinnitus with KM occurred in 1% and dirrhea with OFX in 4%. Conclusion: The duration of patient's illness was shorter, sputum AFB smear negative response rate was better. Radiologic responses were not remarkable, but extent of disease by national tuberculosis association was smaller, the result of retreatment was better. Adverse reaction of the secondary antituberculosis agent was mainly observed gastrointestinal troubles, as regard to tolerance to the secondary drugs the role of the physician is of very important value and toxic effects can be overcome by the strong confidence.

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Revision of The Korean Pharmceutical Codex, The Third Edition (의약품 등 기준 및 시험방법(제 3개정) 소개)

  • Choi, Myoeng-Sin;Yang, Ji-Sun;Yoo, Tae-Moo;Kim, In-Kyu;Kim, Hye-Soo;Lee, Sun-Hee;Chang, Seung-Yeup;Cho, Jung-Hee;Lee, Su-Jung;Kim, Young-Lim;Kim, Mi-Jeong;Kim, Eun-Jung;Lee, Jong-Pil;Kim, Do-Hoon;Baek, Kyung-Min;Kim, Hee-Sung;Park, Sang-Aeh;Kang, In-Ho;Kim, Eun-Kyung
    • Journal of Pharmaceutical Investigation
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    • v.35 no.3
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    • pp.201-205
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    • 2005
  • The aim of publishing the Korean Pharmaceutical Codex is to update and set specification of essential drugs for humane health. In accordance with speedy development of new drugs and improvement of science and technology, the need of revision of drug specification through the ICH guidelines and discussions between regulatory agency and pharmaceutical industry for the quality assurance of safer and efficient drugs is getting higher. The first edition of Korean Pharmaceutical Codex was published in 1983. Now, the third revision of the Codex is prepared because of the revision of domestic and foreign Pharmacopeias, changes of drug control environment, improvement of science and technology and so on. The aim of 3th edition is to improve the quality of essential drugs through the setting of the required specifications and discussions between the regulatory agency and pharmaceutical industry.

Inhibitory Effect of the Methanolic Extract of Symphyocladia latiuscula on the Growth of HT-29 Human Colon Cancer Cells (보라우무 메탄올추출물의 HT-29 대장암세포 증식 억제 효과)

  • Kim, Eun-Ji;Park, So-Young;Hong, Ji-Eun;Shin, Min-Jeong;Lim, Soon-Sung;Shin, Hyun-Kyung;YoonPark, Jung-Han
    • Journal of the Korean Society of Food Science and Nutrition
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    • v.36 no.4
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    • pp.431-438
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    • 2007
  • In the present study, twenty eight marine algae species were evaluated for their antiproliferative effect on HT-29 human colon cancer cells. Among these, the methanolic extract of Symphyocladia latiuscula (SL Ex) showed the highest inhibitory activity on HT-29 cell growth. In this study, we examined the mechanism by which SL Ex inhibited the HT-29 cell growth. Cells were cultured with various concentrations of $(0{\sim}20{\mu}g/mL)$ SL Ex. The SL Ex substantially decreased the viable cell numbers and induced apoptosis of HT-29 cells in a dose-dependent manner Western blot analyses of total cell lysates revealed that SL Ex increased the levels of cleaved caspase-8, -9, -7, and -3, and poly (ADP-ribose) polymerase in HT-29 cells. In addition, SL Ex increased truncated Bid levels but moderately decreased Bax levels at only $20{\mu}g/mL$. Furthermore, SL Ex did not affect Bcl-2 protein levels but increased the levels of Fas in HT-29 cells. The present results indicate that SL Ex inhibits cell growth via inducing apoptosis in human colon cancer cells. The mechanism of apoptosis induction by SL Ex involves caspase-8 activation leading to changes in mitochondrial events and subsequent activation of the caspase-7/caspase-3 cascade. Our finding may lead to the development of new therapeutic strategies for the treatment of colon cancer.

Globalization and Independency of Populist Nations' Welfare Policies: Focusing on the Influences of Multinational Pharmaceutical Companies on the Korean Government's Policy on the Pharmaceutical Industry (세계화와 국민국가의 복지정책 자율성: 다국적 제약자본이 우리나라 제약정책 결정에 미친 영향을 중심으로)

  • Lee, Su-Yun;Kim, Young-Mi
    • Korean Journal of Social Welfare
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    • v.57 no.3
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    • pp.5-30
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    • 2005
  • Globalization has conflicting effects on pharmaceutical policies. A change into a 'populist competitive nation' due to globalization strengthens policies to reduce drug manufacturing costs while the WTO's TRIPS Agreement that is affected by multinational pharmaceutical companies increases drug manufacturing costs by bolstering the patent rights on new drugs. Currently, the independency of populist nations' policies to reduce drug manufacturing cost is being compromised because multinational organizations(such as the European Union) which represents the interests of the multinational pharmaceutical companies put restrictions on the pharmaceutical policies of populist nations for purposes of promoting the industrial goals of the multinational companies. Korea is no exception. Up until the late 1990s, the main feature of the pharmaceutical policies in Korea was keeping the drug price at the cost level based on a growth-driven ideology, and this was Korea's unique policy tools as a developing nation. However, the increase in the power of multinational pharmaceutical companies currently infringes on the independency of Korea's pharmaceutical policies. Expensive imported drugs were originally covered by the national health insurance plan, but starting from 1999 such drugs began to be covered by the plan. After separation of medical and pharmaceutical services, the use of expensive drugs was increased, and the Korean government planned to introduce the reference price policy in order to contain the cost of the national health insurance plan. However, due to pressures from the U.S. government as well as multinational pharmaceutical companies, implementation of the policy has been postponed. In addition, due to a pressure from the U.S. government, a working group was created which would affect the health care policy of the Korean government. Discussions so far on globalization was about whether the change into populist competitive nations due to globalization resulted in the reduction of welfare spending. However, this study shows not only the reduction of health care cost through policies to reduce drug manufacturing costs but increase in welfare spending by raising the strengths of multinational pharmaceutical companies that are for-profit providers of welfare service. While focusing on the contradictory effects of globalization on pharmaceutical policies of a nation, this study looked at how these conflicting effects end up promoting the interests of multinational pharmaceutical companies by examining the Korean case.

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Effect of the Hexane Extract of Saussurea lappa on the Growth of HT-29 Human Colon Cancer Cells (목향 헥산추출물이 대장암세포인 HT-29 세포의 증식에 미치는 영향)

  • Kim, Eun-Ji;Park, Hee-Sook;Lim, Soon-Sung;Kim, Jong-Sang;Shin, Hyun-Kyung;Yoon, Jung-Han
    • Korean Journal of Food Science and Technology
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    • v.40 no.2
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    • pp.207-214
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    • 2008
  • In Asia Saussurea lappa (SL) has been used as a traditional herbal medicine to treat abdominal pain and tenesmus. Recently, in vitro cell culture studies have shown that SL has anti-ulcer, anti-inflammatory, and anti-tumor properties. To explore its potential chemopreventive and chemotherapeutic effects in colon cancer, we examined whether the hexane extract of SL (HESL) could inhibit the growth of HT-29 human colon cancer cells, and investigated the mechanisms for this effect. The cells were cultured with various concentrations (0-5 ${\mu}g/mL$) of HESL. The results indicated that HESL markedly decreased the numbers of viable HT-29 cells; whereas at the concentration of 5 ${\mu}g/mL$, HESL slightly decreased the viable cell numbers of CCD 1108Sk human skin normal fibroblasts at 72 hr. HESL substantially increased the numbers of cells in the sub G1 phase, and dose-dependently increased apoptotic cell numbers. Western blot analysis of the total cell lysates revealed that HESL increased Bax protein levels, but did not affect Bcl-2 levels. HESL induced the cleavage of poly (ADP-ribose) polymerase and caspases 8, 9, 7, and 3. This study demonstrated that HESL inhibits cell growth and induces apoptosis in HT-29 cells, which may be mediated by its ability to increase Bax levels and activate the caspase pathway. These findings may lead to the development of new therapeutic strategies for colon cancer treatment.