Proceedings of the PSK Conference (대한약학회:학술대회논문집)
The Pharmaceutical Society of Korea
- 기타
Domain
- Health Sciences > Development of Pharmaceutical
2003.10a
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It seems that the pharmacy has been too much concerned about either science or professional business, neglecting the pharmaceutical identity. Here, we the pharmacists should consider the root how the pharmacist profession was born. The most important role of pharmacists in their own profession is to review the prescriptions written by physicians. (omitted)
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It is imperative that Schools of Pharmacy push the frontiers of their science. Those professions that do not do their own research are technical fields and not professions. With that imperative it is important to develop a perspective on the historic evolution of research in Schools of Pharmacy, that was in concert with the subject matter of the professional curriculum, and has changed somewhat in modem times to reflect not only our professional program but also our mandate to graduate student education and training and to elevate the status of schools of pharmacy in research intensive universities. (omitted)
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BT(Biotechnology) is transition stage from study and technology to mass production and one of most promising part in leading industry. After early completion of genome project, many countries keep trying their best to preoccupy in this field. Korean government support BT more than 10 years. Because their eco-compatibility and cleanness, BT is very promising part. But the big issue is the morals of genetic manipulation. (omitted)
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This presentation briefly will be introduced on new drug approval process and the review of safety and efficacy of drugs in Korea. First, we will present the regulation related to new drug registration [Regulation of the Efficacy and Safety Evaluation of Drugs, etc (Notification No. 2003-17), Standards for Toxicity Test of Drugs, etc(Notification 1999-61) and GLP Regulation for Nonclinical Laboratory Studies (Notification No. 2000-63)] and the regulation related to clinical trial [Guidelines to Clinical Study Authorization for Drugs (Notification No. 2002-65)] and [Korean Good Clinical Practice(KGCP, Notification No. 1999-67) Regulation]. (omitted)
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“Roundup BioKorea” is the project to develop the role of Korea Food and Drug Administration in leading the process of the effective materials from basic research work to licensed commercial BioProducts. Korean government has invested a large amount of budget to a biotechnological area by “Biotech 2000” program since 1994. (omitted)
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KGMP is the one of the most important part in Drug administration system which drug industry must comply to. KGMP was revised newly with the harmonization of other countries and keep face with new technologies. The big revision point is bulk drug GMP, blood products GMP, validation guideline and standardization of injection manufacturing. (omitted)
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After approval, the drug should be manufactured and maintained with uniform quality. To assure the quality of drugs, the drug companies should comply with GMP guidelines and regulatory authorities should assess their compliance. In this article, I want to review the definition of drugs as well as the quality surveillance system. To be controlled as drugs, they ought to have their own specifications and test methods. (omitted)
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People usually try to take in nutrition component which is necessary for physical growth, developing and maintaining the health through usually balanced dietary life. However in looking over the results of recent national nutrition survey, even if the nation’s average taking in nutrition condition is fairly good, considering the individual cases there has happened a problem about the balance of taking in nutrition due to the wrong dietary life. (omitted)
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“Magmi” is a symbolic character of Korean association against drug abuse. “Magmi” is a word created by the sounds made by “mag eum yi” meaning one who stops drug and substance abuse. It will be played with CD at the worshop held on PHARMDAY. (omitted)
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Efficacy and safety of drugs are evaluated in the process of drug registration along with the basis of setting test method and acceptance criteria for assuring quality of the drugs. Quality of drugs plays a key role to guarantee the efficacy and safety of drugs approved in the evaluation process at the marketing stage after approval. Most important role of pharmacopoeia is to give the basis of assuring the quality of drugs. (omitted)
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There have been remarkable medical advances, largely as the result of improved understanding of disease mechanisms and of advances in human genetics at the individual level. Subsequently, remarkable effective medicines continue to be discovered at an increasing rate. Development of these medicines become increasingly complex, accompanied by globalization and global standards, requiring ever higher standards of efficacy, safety and quality. (omitted)
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The present topic in pharmaceutical industry is to establish Quality Assurance System for medicinal product Therefore, the most important and urgent subject to be solved in the field of the manufacturing industry is to establish, implement and maintain the control system for ensuring uniformity of medicinal product. In case of solid dosage forms for internal use, its quality was controlled by disintegration test, etc but at present bioavailability could be predicted with dissolution test and so the assurance of its uniformity should be prerequistie to preserve suitable dissolution of the manufactured medicinal product. (omitted)
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Recently, Korean Food and Drug Administration (KFDA) has been attempting to modernize the review processes for generic drug products. Obviously, the modernization effort will lead to harmonize the guidelines in the process to the internationally acceptable level. In general, the Korean version of abbreviated new drug application (ANDA) consisted of similarly to those in developed countries (viz, specifications for bulk drug/preparation, bioequivalence, and stability); However, there exists a significant gap in the sophistication of the guidelines between the Korean version and those in the other countries. (omitted)
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The mission of pharmacopoeia is to promote the public health by establishing and disseminating the officially recognized standards of the quality of medicines and authoritative information about the use of them and other health care technologies by health professionals, patients, and consumers. Korean Pharmacopoeia was first established on October 10, 1958 and revised per 5 years. 8th edition was published December 30, 2002 and we are preparing English edition. (omitted)
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Although Cyclosporin A (CsA) is a powerful immunosuppresant with little adverse effect on the bone marrow, CsA administered orally in the general formulation cannot obtain high bioavailability due to its poor aqueous solubility. To improve the solubility and enhance the bioavailability of poorly water-soluble CsA, many different approaches have been made in our laboratory. (omitted)
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Development of drug delivery systems has been recognized as one of portfolios to gain a competitive edge in pharmaceutical industry over 30 years. The application of drug delivery technologies offers pharmaceutical companies and patients several therapeutic benefits, including improving efficacy and adverse effect profiles, enhancing patient compliance and potentially regenerating unsuccessful drugs. (omitted)
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Aceclofenac (AFC) as a model has poor solubility in water, resulting in lower dissolution rate and bioavailability. A solid dispersion (SD) is one of effective methods to enhance the solubility or dissolution rate of various poorly water-soluble drugs. Polyvinylpyrrolidone (PVP) that is a nontoxic, water-soluble and generally applicable pharmaceutical excipient has been widely used as a carrier in the preparation of solid dispersions. (omitted)
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Radiation therapy has been used for the cancer treatment externally or internally. The external radiation therapy has been widely used, but for the lack of its selectivity it requires strong radiation dose causing the dermal irritation and radiation effect of the normal tissues or organs. So we investigate non-clinical and clinical studies of “Milican inj.”, in which chitosan is chelated with 166-Holmium, as an anticancer agent for internal radiation therapy. (omitted)
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Carduus marianus extract (formally called silymarin) have been used mainly as a medicament for hepatobiliary diseases. The major component of silymarin is silybin, which constitutes between 50 and 70% of the drug and is the major active component. Many experiments show the efficacy of silybin parenterally administerated. But, its bioavailability is low after oral administration due to its low solubility in water. (omitted)
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Dimethyl-4,4’-dimethoxy-5,6,5’, 6’-dimethylenedioxybipheny-2,2’ -dicarboxylate (DDB) is a synthetic analogue of Schisandrin C, one of the components isolated from Fructus Schisandrae which is a traditional Chinese medicine and has been known to be effective in improvimg liver functions. DDB is currently used clinically for patients with hepatitis virus B. (omitted)
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There is considerable interest in the screening of higher plant extracts in modem drug discovery programs to discover new chemotypes with potent and selective biological activity. Such work may be performed in different laboratory settings, including those in academic institutions. In the case of cancer, plants offer the potential for the discovery of both cancer chemotherapeutic agents and cancer chemopreventives. (omitted)
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Human Genome Project has recently been completed and the information on nucleotide sequences of our whole genome is now available at the public or commercial data banks. Next goals are to identify the functions of each gene and to elucidate the intracellular signal transduction pathways regulating gene expression. We have established a PCR-based bioassay to search for biologically active compounds that can modulate the expression of genes encoding important proteins. (omitted)
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The commitment of T helper (Th) cells to Thl or Th2 cells is of crucial importance with respective to susceptibility or resistance to particular infections, or to autoimmune diseases and allergic diseases. The nature of Thl or Th2 polarizing signals is not yet fully understood. However, the cytokines that are present in the environment of the
$CD4^{+}$ T cell at the time it encounters the antigen significantly regulate the differentiation of Th cells into either Thl or Th2 subsets. (omitted) -
Investigation of immunomodulating activities of the Agastache rugosa (Bae-cho-hyang) extract and its components was preformed through screening in vitro assays and evaluating anti-inflammatory activity and anti-atherosclerotic activity of the extract and tilianin in vivo. The extract showed strong anti-inflammatory activity in carrageenan-induced acute edema mouse model and anti-atherogenic activity in LDLR (low density lipoprotein receptor) deficient mouse model. (omitted)
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Mast cell playa crucial role in allergic and inflammatory disease through the exocytosis of preformed granule-associated mediators, such as histamine, serotonin, proteases and the generation of newly synthesized lipid mediators such as, leucotrien (LT)
$C_4$ and prostaglandin (PG)$D_2$ in response to crosslinking of high affinity for IgE (Fc$\gamma$ RI). New eicosanoids are synthesized by the oxidative metabolism of arachidonic acid, which is generally esterified sn-2 position of the major classes of glycerophospholipids. (omitted) -
In mammalians, ketone bodies (acetoacetate, D(-)-3-hydroxybutyrate and acetone) are generated mainly in the liver via the 3-hydroxy-3-methylglutaryl-CoA pathway, carried to and utilized in extrahepatic tissues as an energy source during starvation and diabetes in particular due to their overproduction as the consequence of elevated fatty acid oxidation and lowered glucose metabolism. (omitted)
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Several epidemiological studies suggested that arsenic exposure was strongly correlated with the development of cardiovascular disease such as hypertension. In order to examine whether arsenic affects vasomotor tone in blood vessels, we investigated the effect of arsenic on agonist-induced vasorelaxation using the isolated rat aortic rings in in vitro organ bath system. (omitted)
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Yu, Il-Je;Park, Jung-Duck;Park, Eon-Sub;Song, Kyung-Seuk;Han, Kuy-Tae;Han, Jeong-Hee;Chung, Yong-Hyun;Park, Byung-Sun;Chung, Kyu-Hyuck 72
Welders working in a the confined space, like in the shipbuilding industry, are have at risk of being exposed toing a high concentrations of welding fumes and of developing pneumoconiosis or other welding- fume exposure related diseases. Among such diseasesthem, manganism resulting fromcaused by welding- fume exposure remains ais still controversial issue, as the movement ofnd no clear demonstration of manganese movement into the specific brain regions has not been clearly established. (omitted) -
The heavy metal cadmium is a xenobiotic toxicant of environmental and occupational concern and it has been classified as a human carcinogen. Inhalation of cadmium has been implicated in the development of emphysema and pulmonary fibrosis, but, the detailed mechanism by which cadmium induces adverse biological effects is not yet known. Therefore, we undertook the investigation of genes that are induced after cadmium exposure to illustrate the mechanism of cadmium toxicity. (omitted)
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Methylmercury (MeHg) is a ubiquitous environmental toxicant that can be exposed to humans by ingestion of contaminated food including fish and bread. MeHg has been suggested to exert its toxicity through its high reactivity to thiols, generation of arachidonic acid and reactive oxygen species (ROS), and elevation of intracellular
$Ca^{2+}$ levels ([$Ca^{2+}$ ]i). However, the precise mechanism has not been fully defined. (omitted) -
Polyketides are a class of structurally diverse natural products which possess a wide range of biological activities. These compounds are used throughout medicine and agriculture as antimicrobials, immunosuppressants, antiparasitics, and anticancer agents. While structurally diverse, polyketides are assembled by a common mechanism of decarboxylative condensations of simple malonate derivatives by polyketide synthases (PKSs) in a manner very similar to fatty acid biosynthesis (Fig 1). (omitted)
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A lot of polyketide antibiotics have been isolated from natural sources like microorganism, fungi and plant. The polyketide natural products have biologically and medically important activities, including antibacterial, anticancer, antiparasitic, and immunosuppressant properties. The diversified activities of polyketides are originated from their structural variety of which have been took advantage by several research groups for development of new drugs. (omitted)
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Sohng, Jae-Kyung;Kharel, Madan-Kumar;Bimala Subba;Woo, Jin-Suk;Kim, Byung-Gee;Liou, Kwang-Kyoung;Lee, Hei-Chan 81
Aminoglycoside antibiotics are among the chlinically important antibiotics and a major structural feature is the existence of characteristic aminocyclitol aglycones [1]. Considering the structural features, aminoglycosides are classified in to two classes. The first are those containing fully substituted aminocyclitol such as streptomycin, hygromycin, fortimycin, etc. (omitted) -
$\beta$ -Lactams are historically and clinically representative antibiotics used for therapeutic purposes. In early days, penicillin (penam antibiotic) and cephalosporin (cephem antibiotic) were found in culture broth of two different filamentous fungi, Penicillium chrysogenum and Acremonium chrysogenum. Since 1970, a variety of$\beta$ -lactam structures have been discovered from bacterial cultures including Streptomyces species, which are known as cephamycin, cephabacin (cephem antibiotics), clavulanic acid (oxopenam antibiotic), thienamycin (carbapenem antibiotic), and sulfazecin (monobactam antibiotic). (omitted) -
The syntheses of different types of stilbenoid libraries have been studied recently. In these courses, the screening of the generated natural product-mimic focused libraries led to the identification of the novel lead compounds for human cytochrome P450 (CYP) lAs, melanin production, and sortase A. A library of trans-stilbene derivatives was prepared through a new efficient solution pahse synthetic pathway and their inhibitory activities were evaluated on human cytochrome P450s(CYP) 1A1, 1A2, and 1B1 to find a potent and selective CYP1 inhibitor. (omitted)
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Numerous lead compounds, based on multipurpose privileged structures, can be generated that address a variety of targets from a gene family of interest, irrespective of therapeutic area. Solid-phase organic synthesis has been emerged as a powerful technique in generating combinatorial libraries of small organic molecules useful for drug discovery. Heterocyclic compounds provide scaffolds on which pharmacophores can be arranged to yield potent and selective drugs and a variety of heterocycles have been synthesized on solid support. (omitted)
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I describe here a novel and promising approach to drug discovery that involves the identification and assembly of drug-like fragments to afford lead compounds. This approach is attractive for a number of reasons. First, the productive assembly of two weakly bound fragments, even fragments with independent dissociation constants in the low mM range, can potentially afford ligands with sub-micromolar affinities for their targets. (omitted)
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The beta-turn has been implicated as an important conformation for biological recognition of peptides or proteins. We adapted the concept of general Ca atom positioning from the cluster analysis and recombination of each ideal beta-turn conformation pattern by Garland and Dean (1. Computer-Aided Molecular Design, 1999, 13, 469) as one strategy of designing non-peptide beta-turn scaffolds. (omitted)
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The drug discovery landscape is changing rapidly in the post-genomic era. Mapping of the human genome has led to an abundance of potential drug targets. Drug discovery times and costs can be significantly reduced by developing methods for high throughput target identification/ validation, multiplexed assay development and high efficient combinatorial chemistry. (omitted)
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RNA plays an important role in numerous biological processes but little is known about the interactions between small organic molecules and RNA. Our previous work has shown that the heterodimeric compound designed by conjugation with neomycin and loop-specific chemical bind to the stem-loop structured RNA motifs. In the present study, heterodimer was used, in a reverse way, as a probe to identify structured RNA motifs. (omitted)
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Local cytosolic rises of
$Ca^{2+}$ appears to be critical in the regulation of many cellular activities, including muscle contraction, neurotransmitter secretion, and cell death. Cardiac$Ca^{2+}$ signaling similarly begins with discrete and localized rises of$Ca^{2+}$ ($Ca^{2+}$ sparks) triggered by$Ca^{2+}$ current ($I_{Ca}$ ). The large local releases of$Ca^{2+}$ in turn modulate L-type$Ca_{v}$ 1.2(${\alpha}_{1C}$ $Ca^{2+}$ channels, suggesting that discrete$Ca^{2+}$ cross-signaling may occur in the micro-domains of${\alpha}_{1C}$ /ryanodine receptors (RyRs). (omitted) -
Telomerase activity is expressed in most types of cancer cells but not in normal somatic cells, suggesting that telomerase may be an important target for cancer chemotherapy. Inhibition of telomerase results in telomere erosion leading to the subsequent growth-arrest of cancer cells followed by senescence or cell death. In this study, we screened a chemical library for inhibition of human telomerase, identifying two groups of inhibitors. (omitted)
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With advances in determining the entire DNA sequence of the human genome, it is now critical to systematically identify the function of a number of genes in the human genome. These biological problems, especially those in human diseases including cancer, should be addressed in human cells in which genetic approaches have been extremely difficult to implement. To overcome this, my efforts have focused on the development of a novel “chemical genetic/genomic approach” that uses small molecules to “probe and identify” the function of genes in specific biological process or pathway in human cells. (omitted)
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Cell-cell and cell-matrix interaction is clearly required for metazoans not only to hold their cells together but also to conduct more sophisticated biological processes. Each cell has adhesion molecules on its cell membrane to link extracellular matrix and adjacent cells to the intracellular cytoskeleton, and also to transduce signals. In complex metazoans, information is transmitted from one cell to another by mechanisms such as direct intercellular communication, soluble signal molecules among distant cells, and local cellular environments formed by highly specialized extracellular matrix. (omitted)
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Osteoclast are specialized cells derived from the monocyte/macrophage haematopoietic lineage that develop and adhere to bone matrix, then secrete acid and lytic enzymes that degrade it in a specialized, extracellular compartment. Regulation of osteoclast differentiation is central to the understanding of the pathogenesis and treatment of bone diseases such as osteoporosis. (omitted)
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Hypoxic-ischemic (H-I) encephalopathy in the prenatal and perinatal period is a major cause of morbidity and mortality and often results in cognitive impairment, seizures, and motor impairment (cerebral palsy). Many studies of neonatal H-I brain injury have utilized the well characterized Levine model in which unilateral carotid ligation is followed by exposure to hypoxia. (omitted)
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tIn brain ischemic insult, inflammatory cells such as macrophages and lymphocytes are chemo-attracted into the brain lesion and release cytokines, resulting in an activation of microglia that are functionally equivalent to peripheral macrophages in the central nervous system. In cerebral ischemic insults, activated inflammatory cells such as microglia and macrophages may be implicated in the pattern and degree of ischemic injury by producing various bioactive mediators. (omitted)
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Parkinson's disease (PD) is a common neurodegenerative disorder characterized by a progressive loss of dopaminergic neurons in the substantia nigra. While its precise etiology is unknown, such factors as oxidative stress, impairment of mitochondrial respiration, excitotoxicity and inflammation may play roles in its pathogenesis. Although the role of apoptosis in the process of dopaminergic neuronal death has been highlighted in studies using postmortem brains and experimental models of PD, other evidence implicates both apoptosis and non-apoptotic death in PD. (omitted)
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Morphine is a potent analgesic and addictive substance. Morphine produces neurotoxicity such as rewarding effect, analgesic tolerance and physical dependence. It has been restricted to the use of morphine in patients because of these problems. The present study was investigated the effect of berberine on the neurotoxicity of morphine. Repeated administration of morphine produced conditioned place prefernece (CPP) and behavioral sensitization in mice. (omitted)