• Proceedings of the PSK Conference
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• 2002.10a
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• pp.234.1-234.1
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• 2002

Any food additive as a chemical synthetic compound. whose criteria and standards are not notified publicly and foods using an food additives containing such a chemical synthetic compound or foods containing it shall not be sold. or manufactured. imported. processed. used. prepared. stored. transported. or displayed for the purpose of sale. Some food manufacturers have illegally added drugs to foods not notifying this. Moreover. structure-modified new drugs could be added. But it is almost impossible to detect these by ordinary laboratory inspection. Thus the study about the identification of analogues of pending drugs is imminent. (omitted)

• Knowledge Management Research
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• v.21 no.3
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• pp.105-121
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• 2020

With regard to the development of new drugs, what is most important for a Korean Biotech, where no global sales network has been established, is decision-making related to out-licensing of new drugs. The probability of success for each clinical phase is different, and the licensing amount and its royalty vary depending on which clinical phase the licensing contract is made. Due to the nature of such a licensing contract and Biotech's weak financial status, it is a very important decision-making issue for a Biotech to determine when to license out to a Big Pharma. This study defined a model called 'optimal timing for out-licensing of new drugs' and the results were derived from the decision tree analysis. As a case study, we applied to a Biotech in Korea, which is conducting FDA global clinical trials for a first-in-class new drug. Assuming that the market size and expected market penetration rate of the target disease are known, it has been shown that out-licensing after phase 1 or phase 2 of clinical trials is a best alternative that maximizes Biotech's profits. This study can provide a conceptual framework for the use of management science methodologies in pharmaceutical fields, thus laying the foundation for knowledge and research on out-licensing of new drugs.

• The Korea Journal of Herbology
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• v.30 no.5
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• pp.75-83
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• 2015

Objectives : The aim of this study was to find how Northeast Asia(Korea, China, Taiwan, Japan) supervise herbal formulas in their pharmacopoeia.Methods : We compared items, formula's effects, formulations, etc and analyzed common formulas among Northeast Asia`s herbal pharmacopoeia (Korea(2010), China(2010), Taiwan(2013), Japan(16th Edition), drugs in Japan OTC Drugs (2007-2008))Results : The Korean Pharmacopoeia, the Korean Herbal Pharmacopoeia, Taiwan herbal pharmacopoeia, the japanese pharmacopoeia, drugs in Japan OTC drugs and pharmacopoeia of the People's Republic of China have 5, 251, 200, 20, 294, 1059 formulas, respectively. In comparison of pharmacopoeia`s test item, Korea and Japan has many similarity, for example, not refer to the effect of formulas. Korea and China have many inspection test of formulations in pharmacopoeia. Each country has differences in ratio of efficacy categories. For example, China especially has a higher ratio of formulas that regulate the blood and Korea has higher ratio of formulas that calm the spirit and open the sensory orifices than those of other 3 countries. There are 17 common formulas among the 4 countries and 43 common formulas among Korea, Taiwan and Japan. Comparing dosage forms, Korea, Japan, Drugs In Japan OTC drugs, Taiwan, China uses 4, 2, 14, 3, 21 formulations, respectively.Conclusions : China has many formulations and new formulas. Taiwan and Japan supervised formulas only selected by the authorities. However, Korean pharmacopoeia has similar form with Japan and need to add more formulas on demand and new formulations.

• YAKHAK HOEJI
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• v.50 no.3
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• pp.145-153
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• 2006

The adverse events which do not appear in the approval process tend to occur more frequently at the early stage of the use. Therefore new drugs, drugs with different active substances or routes of administration, or drugs with explicitly different efficacy added are particularly chosen for re-examination, and go through a study, which is conducted on 600 to 3,000 subjects over 4 to 6 years. Since the re-examination system was implemented in January 1995, 880 drug products have been designated as the subject of re-examination and among them 194 drugs have been completed their re-examination as of until March 2005. Post Marketing Surveillance to insure drug safety should be correlated with re-examination of new drug, re-evaluation of drug, and adverse event monitoring system. And the first labeling change should reflect all information collected for a defined period of time after the marketing authorization is granted. Furthermore centralized management through spontaneous reporting system of adverse event for whole period of time would be the most desirable type of system.

• Journal of Pharmaceutical Investigation
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• v.20 no.1
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• pp.35-42
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• 1990

A new form of sulfabenzamide was characterized using X-ray diffraction patterns and differential scanning calorimetry. Solubility studies demonstrated that, of the sulfabenzamide polymorphs, the new form was more soluble than form I. Compression of the new form at compression force of 1000 $kg/cm{^2}$ didn't induce polymorphic change in the crystal. Similar patterns were also produced through grinding. The effects of some diluents on the polymorphic transformation from the new form into form I by grinding and compression were also studied. Three diluents, $Avicel^{\circledR}$, lactose and starch showed no influence on the polymorphic transformation. The new form seemed to be more suitable for the pharmaceutical preparation.

• Biomolecules & Therapeutics
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• v.30 no.1
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• pp.80-89
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• 2022

The targeting of DNA methylation in cancer using DNA hypomethylating drugs has been well known to sensitize cancer cells to chemotherapy and immunotherapy by affecting multiple pathways. Herein, we investigated the combinational effects of DNA hypomethylating drugs and ionizing radiation (IR) in human sarcoma cell lines both in vitro and in vivo. Clonogenic assays were performed to determine the radiosensitizing properties of two DNA hypomethylating drugs on sarcoma cell lines we tested in this study with multiple doses of IR. We analyzed the effects of 5-aza-dC or SGI-110, as DNA hypomethylating drugs, in combination with IR in vitro on the proliferation, apoptosis, caspase-3/7 activity, migration/invasion, and Western blotting using apoptosis- or autophagy-related factors. To confirm the combined effect of DNA hypomethylating drugs and IR in our in vitro experiment, we generated the sarcoma cells in nude mouse xenograft models. Here, we found that the combination of DNA hypomethylating drugs and IR improved anticancer effects by inhibiting cell proliferation and by promoting synergistic cell death that is associated with both apoptosis and autophagy in vitro and in vivo. Our data demonstrated that the combination effects of DNA hypomethylating drugs with radiation exhibited greater cellular effects than the use of a single agent treatment, thus suggesting that the combination of DNA hypomethylating drugs and radiation may become a new radiotherapy to improve therapeutic efficacy for cancer treatment.

• Korean Journal of Pharmacognosy
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• v.44 no.3
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• pp.291-297
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• 2013

Sophorae Flos (SF), a composite of flowers and flower-buds of Sophora japonica, has long been used in traditional Korean and Chinese medicines for the treatment of hemostasis and inflammation. In this study, we investigated anti-inflammatory effect of four EtOH extracts at the difference in blooming stages of flowers on LPS-induced inflammation in RAW264.7 cells. We classified the flowers of Sophora japonica with SF-1 (length of flower is shorter than calyx), SF-2 (length of calyx is shorter than flower), SF-3 (full bloom), and SF-4 (not blooming at all). We examined HPLC analysis, whether quercetin and rutin are major component of these Sophorae Flos extracts or not. As a result, SF-1 contained quercetin, but the others did not. In addition, quercetin, SF-1, and SF-4 act on the suppression of pro-inflammatory mediators including inducible nitric oxide synthase (iNOS), cyclooxygenase (COX)-2, nitric oxide (NO), prostaglandin E2 ($PGE_2$) against lipopolysaccharide (LPS)-induced activation in RAW264.7 cells. Of these, SF-1 showed the best anti-inflammatory effect. These results suggest that Sophorae Flos with the highest content of quercetin would be used for the treatment of various inflammation diseases.

• Korean Journal of Clinical Pharmacy
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• v.22 no.3
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• pp.260-267
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• 2012

The objective of this study was to investigate drug classification system in Korea and other developed countries. Laws and regulations of Korea regarding the system were retrieved from sources posted in Ministry of Government Legislation. We also reviewed previous research reports performed as part of government's effort to reform the system The system in the foreign countries was retrieved from the official homepage operated by each country's government. There have been two research funded by Korean government, which strongly suggested that the system should be reformed. However, we found that the system was never reformed and still effective. Drug classification system in US and most western countries consists of two categories, i.e., prescription drugs and non-prescription drugs except UK, which classifies into three categories: Prescription Only Medicines, Pharmacy Medicines, and General Sales List Medicines. Interestingly, in Japan, non-prescription drugs are further classified into three groups: Group 1, 2, and 3. Recently, Ministry of Health and Welfare (MOHW) in Korea proposed a plan to reclassify all the approved drugs according to purportedly rational and scientific criteria. However, the plan does not include reform of the existing laws and regulations, which appears that it is just one-time action rather than a sustainable administration backed up by law. Therefore, it is recommended that Korean MOHW take appropriate action on laws and regulations with regard to the system to meet global harmonization standard.

• Asian Pacific Journal of Cancer Prevention
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• v.14 no.10
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• pp.5599-5608
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• 2013

With the high morbidity and mortality caused by cancer, finding new and more effective anti-cancer drugs is very urgent. In current research, biotransformation plays a vital role in the research and development of cancer drugs and has obtained some achievements. In this review, we have summarized four applications as follows: to exploit novel anti-cancer drugs, to improve existing anti-cancer drugs, to broaden limited anti-cancer drug resources and to investigate correlative mechanisms. Three different groups of important anti-cancer compounds were assessed to clarify the current practical applications of biotransformation in the development of anti-cancer drugs.

• Journal of Microbiology and Biotechnology
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• v.30 no.12
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• pp.1843-1853
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• 2020

COVID-19, caused by the novel coronavirus SARS-CoV-2, has spread globally and caused serious social and economic problems. The WHO has declared this outbreak a pandemic. Currently, there are no approved vaccines or antiviral drugs that prevent SARS-CoV-2 infection. Drugs already approved for clinical use would be ideal candidates for rapid development as COVID-19 treatments. In this work, we screened 1,473 FDA-approved drugs to identify inhibitors of SARS-CoV-2 infection using cell-based assays. The antiviral activity of each compound was measured based on the immunofluorescent staining of infected cells using anti-dsRNA antibody. Twenty-nine drugs among those tested showed antiviral activity against SARS-CoV-2. We report this new list of inhibitors to quickly provide basic information for consideration in developing potential therapies.