• Title/Summary/Keyword: New drug development

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Development of a New Similarity Index to Compare Time-series Profile Data for Animal and Human Experiments (동물 및 임상 시험의 시계열 프로파일 데이터 비교를 위한 유사성 지수 개발)

  • Lee, Ye Gyoung;Lee, Hyun Jeong;Jang, Hyeon Ae;Shin, Sangmun
    • Journal of Korean Society for Quality Management
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    • v.49 no.2
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    • pp.145-159
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    • 2021
  • Purpose: A statistical similarity evaluation to compare pharmacokinetics(PK) profile data between nonclinical and clinical experiments has become a significant issue on many drug development processes. This study proposes a new similarity index by considering important parameters, such as the area under the curve(AUC) and the time-series profile of various PK data. Methods: In this study, a new profile similarity index(PSI) by using the concept of a process capability index(Cp) is proposed in order to investigate the most similar animal PK profile compared to the target(i.e., Human PK profile). The proposed PSI can be calculated geometric and arithmetic means of all short term similarity indices at all time points on time-series both animal and human PK data. Designed simulation approaches are demonstrated for a verification purpose. Results: Two different simulation studies are conducted by considering three variances(i.e., small, medium, and large variances) as well as three different characteristic types(smaller the better, larger the better, nominal the best). By using the proposed PSI, the most similar animal PK profile compare to the target human PK profile can be obtained in the simulation studies. In addition, a case study represents differentiated results compare to existing simple statistical analysis methods(i.e., root mean squared error and quality loss). Conclusion: The proposed PSI can effectively estimate the level of similarity between animal, human PK profiles. By using these PSI results, we can reduce the number of animal experiments because we only focus on the significant animal representing a high PSI value.

Protective Effect of Glycyrrhiza New Domestic Variety on the Acute Pancreatitis (국내 감초 신품종의 급성 췌장염 보호 효과)

  • Dong-Gu Kim;Kyung Hyun Min
    • Korean Journal of Plant Resources
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    • v.36 no.4
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    • pp.282-289
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    • 2023
  • Glycyrrhiza korshinskyi Grig. (Gk), which is a new variety of Glycyrrhiza, was developed by the National Institute of Horticultural and Herbal Science in Korea Rural Development Administration. It is improved the limitations of traditional Glycrrhiza species such as G. uralensis Fisch., G. glabra L., and G. inflata Batal. and has been reported various pharmacological effects. The aim of this study is to investigate the protective effect of Gk on the acute pancreatitis, because which has not been revealed yet. AP was induced via intraperitoneal injection of cerulein (50 ㎍/kg) hourly for 7 times in C57BL/6 mice. Gk water extract (20 or 50 mg/kg) or saline was administrated via oral gavage 1 h before the first injection of cerulein. The mice were sacrificed at 5 h after the final injection of cerulein. The inflammatory cell infiltration in pancreatic tissue was decreased by the administration of Gk water extract compared to the AP group. Also, serum amylase and lipase levels were decreased by the administration of Gk water extract compared to the AP group. These results suggest that Gk have protective effect on the acute pancreatitis.

Studies on the Determination Method of Monascus Pigments in Foods (식품 중 홍국색소의 분석법에 관한 연구)

  • Lee, Tal-Soo;Lee, Young-Ja;Kwon, Yong-Kwan;Park, Jae-Seok;Ko, Hyun-Sook;Sim, Kyu-Chang;Lee, Ju-Yeun;Shin, Jae-Wook;Song, Jee-Won;Lee, Chul-Won
    • Korean Journal of Food Science and Technology
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    • v.33 no.5
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    • pp.641-644
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    • 2001
  • This study was performed for development of new analytical method of monascus pigments in foods. In this method, analysis of monascus pigment in foods has been carried out by detection of monascin and ankaflavin of the main color component of monascus pigment as indicator compounds. Monascin and ankaflavin were isolated and identified by TLC, HPLC, Prep. HPLC, $^{1}H-NMR$ and Mass spectrophotometer. The analysis of monascin and ankaflavin in foods such as massal, sausage, mixed press ham, mixed fish sausage, semi-dried sausage and syrup was performed by using reverse phase high performance liquid chromatograph with Capcell Pak C18 column at wave length 390 nm. The quantitative results of monascin were as follows : $0.01{\sim}3.31\;{\mu}g/g$ item in massal, $0.05{\sim}0.10\;{\mu}g/g$ in mixed fish sausage, and $0.34{\sim}0.35\;{\mu}g/g$ in semi-dried sausage. But the quantitative results of ankaflavin were as follows: $0.02{\sim}0.89\;{\mu}g/g$ in massal, ankaflavin were not founded in other samples.

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Estimation of the Impact of the Inclusion of Sharks in the Appendices of the 'Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES)' on Korean Fisheries and Recommendations of the Domestic Measures on the Trade of the Listed Shark Species ('멸종위기에 처한 야생 동식물의 국제거래에 관한 협약'의 상어류 등재가 한국 수산업에 끼칠 영향과 대응 전략)

  • Sohn, Hawsun;An, Du Hae;Kim, Doo Nam;Lee, Sung Il;Park, Kyum Joon
    • Journal of Fisheries and Marine Sciences Education
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    • v.26 no.6
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    • pp.1278-1295
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    • 2014
  • The Sixteenth Meeting of the Conferences of Parties of the Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES), which was held in March 2013 in Bangkok, Thailand, listed five shark species and one genus, and uplisted one sawfish species. All new species listings will be come into force of the eighteen months delay, on the fourteenth of September, 2014. The purpose of the delay is to support the preparation of the domestic measures on shark trade by the parties, as there has been no previous experience in trading the commercially exploited aquatic species in the CITES. The CITES Secretary-General has visited several potential shark trade countries to encourage and facilitate the implementation of the new CITES listings. The newly listed sharks have been caught as a target or non-target species by Korean distant water fisheries and introduced into Korea. So the establishment or change of the domestic laws, regulations, and measures for the implementation of the new CITES species must be prepared before the effective entry date. This paper is prepared to assess the effects of the trade of the CITES listed shark species, and to suggest effective government service measures for the management of Korean distant water fisheries. The Ministry of Environment (MOE) is the general Management Authority of the CITES, and the Ministry of Food and Drug Safety (MFDS) is in charge of the medical trade of CITES listed species in Korea. By law, all imported medicines and medical materials must be inspected by the MFDS during the customs examination; this kind of authority sharing is reasonable and effective way of providing government service. Similarly, the designation of new CITES Management Authority for the trade of commercially exploited aquatic CITES species is critical and the Ministry of Oceans and Fisheries (MOF), which is now in charge of the trade of fisheries products, is the most appropriate governing body for this purpose in Korea. The revision of the National Plan of Action for Conservation and Management of Sharks, initially submitted to the Food and Agriculture Organization (FAO) of the United Nations in 2011 as a practical guideline for shark conservation in all Korean fisheries, could be a effective measure to achieve unification of conservation of endangered species and sustainable use of fisheries stocks. The proper CITES measures for the trade of listed species, such as the establishment of the documenting system for Non-detriment Findings, domestic measures suitable for the "Introduction from the Sea" clause, species specific Harmonized System Codes for the customs service, and an effective shark catch data reporting system should be in place prior to the fourteenth of September 2014.

Effects of Picrorrhiza Rhizoma on Acute Inflammation in Mice

  • Lee, Hyeung-Sik;Ku, Sae-Kwang
    • Biomolecules & Therapeutics
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    • v.16 no.2
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    • pp.137-140
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    • 2008
  • The effects of Picrorrhiza Rhizoma (PR) aqueous extracts were observed on xylene-induced acute inflammation. The xylene was topically applied 60 min after administration of 500, 250 and 125 mg/kg of PR extracts, and all animals were sacrificed 2 hrs after xylene application. The changes on ear weights, histolopathological analyses of ear were evaluated as compared with indomethacin and dexamethasone 15 mg/kg treated groups - well known anti-inflammatory agents. Xylene application resulted in marked increases in induced ear weights as compared with intact control ear. Severe vasodilation, edematous changes of ear skin and increase in the thickness of the ear tissues as acute inflammation were detected in xylene-treated control ears at histopathological observation. However, these xylene-induced acute inflammatory changes were dosedependently decreased by oral treatment of PR extracts. Therefore, it is concluded that PR extracts has favorable anti-inflammatory effects on xylene-applicated acute ear inflamed mice.

Deoxynojirimycin extracted from the Korean Mulberry Plant and Silkworm Exhibits Antiviral Activity in Surrogate Hepatitis C Virus Assays

  • James R. Jacob;Keith Mansfield;You, Jung-Eun;Bud C. Tennant;Kim, Young-Ho
    • Proceedings of the Korean Society of Sericultural Science Conference
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    • 2003.10a
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    • pp.28-33
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    • 2003
  • Over 100 million people worldwide are chronic carriers of hepatitis C virus (HCV)(1). Chronic viral infections of the liver can prouess to cirrhosis, which may ultimately lead to hepatic failure or the development of hepatocellular carcinoma. There are a limited number of antiviral drugs on the market approved fur clinical management of chronic HCV infections; interferon-alpha (IFN$\alpha$) and the nucleoside analog ribavirin. However, whether used as monotherapy or in combination, adverse side-effects are associated with each drug and better therapeutic regimens are needed. (omitted)

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A Clinical Therapeutic Guideline of Antipsychotic Drugs (항정신병약물의 임상치료지침)

  • Yoon, Doh-Joon
    • Korean Journal of Biological Psychiatry
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    • v.1 no.1
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    • pp.7-16
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    • 1994
  • I will try to serve as the basis for the development of a clinical therapeutic guideline of antipsychotic drugs. Knowing that many patients fail standard treatment recommendations, either because of insufficient efficacy or intolerance to adverse effects, led us to emphasize the importance of the guideline. The clinicians continually assimilate new information about recent advances, including : novel agents targeted to impact specific components of various neurotransmitter systems ; combination strategies ; alternative uses of existing agents ; and specialized requirements of a growing number of identified diagnostic subtypes. The cost to benefit ratio must always be considered when developing a therapeutic guideline.

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Molecular Mechanism of Inflammatory Signaling and Predominant Role of Saposhnikovia divaricata as Anti-inflammatory Potential

  • Khan, Salman;Kim, Yeong Shik
    • Natural Product Sciences
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    • v.19 no.2
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    • pp.120-126
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    • 2013
  • Natural products have always been a pivotal source of new drug development. Dry roots of Saposhnikovia divaricata (Turcz.) Schischk. (Umbelliferae) is a perennial herb and is also known as Bang Pung in traditional medicine. Numerous in vitro and in vivo studies have revealed the diverse pharmacological effects of S. divaricata and its role in the treatment of various diseases. This herb has exhibited significant inhibitory effects against inflammation and associated disorders. The present study explored the ethnopharmacological applications and molecular mechanisms behind the anti-inflammatory effects of S. divaricata herb and a single compound blockade of multi-signaling inflammatory cascades. Taken together, this review provides insight into the potential role of S. divaricata against various inflammatory diseases.

An Antimicrobial Activity of a Peptidic Molecule from the Centipede, Scolopendra subspinipes mutilans L. Koch

  • Eun Jae Soon;Leem Jae-Yoon
    • Biomolecules & Therapeutics
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    • v.13 no.4
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    • pp.240-245
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    • 2005
  • An antimicrobial molecule was purified from centipede, Scolopendra subspinipes mutilans L. Koch, by reverse phase-HPLC. Its molecular weight was determined to be 1208.5493 by using matrix-assisted laser desorption ionization-time of flight (MALDI-TOF) mass spectrometry. Total amino acid composition analysis revealed that it consists of E, G, P, V, L, F, and W. It exhibited a broad antimicrobial spectrum against not only Gram-negative, but also Gram-positive bacteria. Furthermore, it was found to have an antimicrobial activity against vancomycin resistant enterococci (VRE). It may be a useful molecule for a new antibiotic development, especially against drug-resistant bacteria. We suggest that it may playa role in the defense system of this animal. This is the first report of a peptidic antimicrobial substance from centipede.

Microencapsulation Methods for Delivery of Protein Drugs

  • Yoon Yeo;Namjin Baek;Park, Kinam
    • Biotechnology and Bioprocess Engineering:BBE
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    • v.6 no.4
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    • pp.212-230
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    • 2001
  • Recent advances in recombinant DNA technology have resulted in development of many new protein drugs. Due to the unique properties of protein druges, they have to be delivered by parenteral injection Although delivery of protein drugs by other routes, such as pulmonary and nasal routes, has shown some promises, to date most protein drugs are administered by par-enteral routs. For long-term delivery of protein drugs by parenteral administration, they have been formulated into biodegradable microspheres. A number of microencapsulation methods have been developed, and the currently used microencapsulation methods are reviewed here, The microen-capsulation methods have been divided based on the method used. They are: solvent evapora-tion/extraction; phase separation (coacervation);spray drying; ionotropic gelation/polyelectrolyte complexation; interfacial polyumerization and supercritical fluid precipitation. Each method is de-scribed fro its applications, advantages, and limitations.

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