• Biomolecules & Therapeutics
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• v.29 no.1
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• pp.22-30
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• 2021

Till the 21st century, fatty acids were considered as merely building blocks for triglycerides, phospholipids, or cholesteryl esters. However, the discovery of G protein-coupled receptors (GPCRs) for free fatty acids at the beginning of the 21st century challenged that idea and paved way for a new field of research, merged into the field of receptor pharmacology for intercellular lipid mediators. Among the GPCRs for free fatty acids, free fatty acid receptor 4 (FFA4, also known as GPR120) recognizes long-chain polyunsaturated fatty acids such as DHA and EPA. It is significant in drug discovery because it regulates obesity-induced metaflammation and GLP-1 secretion. Our study reviews information on newly developed FFA4 agonists and their application in pathophysiologic studies and drug discovery. It also offers a potency comparison of the FFA4 agonists in an AP-TGF-α shedding assay.

• Journal of Pharmaceutical Investigation
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• v.31 no.2
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• pp.131-136
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• 2001

Tofisopam is a new type of tranquilizer valuable for the relief of anxiety and tension in a wide range of emotional disorders. Tofisopam has the therapeutic characteristics of a minor tranquilzer and a mild stimulatory effect. The purpose of the present study was to evaluate the bioequivalence of two tofisopam tablets, $Grandaxin^{TM}$ (Hwan In Pharmaceutical Co., Ltd.) and $Tofim^{TM}$ (Kyung Dong Pharmaceutical Co., Ltd.), according to the guidelines of Korea Food and Drug Administration (KFDA). Eighteen normal male volunteers, $23.11\;{\pm}\;2.83$ years in age and $65.43\;{\pm}\;7.64\;kg$ in body weight, were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After one tablet containing 50 mg of tofisopam was orally administered, blood was taken at predetermined time intervals and the concentrations of tofisopam in serum were determined using HPLC method with UV detector. The pharmacokinetic parameters such as $AUC_t$, $C_{max}\;and\;T_{max}$ were calculated and ANOVA test was utilized for the statistical analysis of the parameters. The results showed that the differences in $AUC_t$, C_{max}\;and\;T_{max}$ between two tablets based on the $Grandaxin^{TM}$ were -5.59%, 2.22% and -13.18%, respectively. Minimum detectable differences $({\Delta})$ at ${\alpha}=0.10$ and $1-{\beta}=0.8$ were less than 20% (e.g., 14.95% and 19.34% for $AUC_t\;and\;C_{max}$, respectively). The powers $(1-{\beta})$ at ${\alpha}=0.10$, ${\Delta}=0.2$ for $AUC_t$ and $C_{max}$ were 95.21% and 81.93%, respectively. The 90% confidence intervals were within {\pm}20%$ (e.g., $-15.64{\sim}4.45$ and $-10.77{\sim}15.21$ for $AUC_t\;and\;C_{max}$, respectively). Two parameters met the criteria of KFDA for bioequivalence, indicating that $Tofim^{TM}$ tablet is bioequivalent to $Grandaxin^{TM}$ tablet.

• Journal of Pharmaceutical Investigation
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• v.29 no.4
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• pp.355-360
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• 1999

Triflusal is a new antithrombotic agent which inhibits both platelet cyclooxygenase and c-AMP phosphodiesterase activity. The purpose of the present study was to evaluate the bioequivalence of two triflusal capsules, $Disgren^{TM}$ (Myung-In Pharmaceutical Co., Ltd.) and $Tigriri^{TM}$ (Hana Pharmaceutical Co., Ltd.) according to the guidelines of Korea Food and Drug Administration (KFDA). Eighteen normal male volunteers, $22.94{\pm}1.83$ in age and $63.7l{\pm}10.43$ kg in body weight, were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After one capsule containing 300 mg of triflusal was orally administered, blood was taken at predetermined time intervals and the concentrations of triflusal in serum were determined using HPLC method with UV detector. Pharmacokinetic parameters such as $AUC_t$ $C_{max}$ and $T_{max}$ were calculated and ANOVA test was utilized for the statistical analysis of the parameters. The results showed that the differences in $AUC_t$ $C_{max}$ and $T_{max}$ between two capsules were -0.30%, 0.81 % and -3.03%, respectively when calculated against the $Disgren_{TM}$ capsule. The powers $(1-{\beta})$ for $AUC_t$ $C_{max}$ and $T_{max}$ were 98.29%,84.73% and 81.02%, respectively. Minimum detectable differences $({\Delta})$ at ${\alpha}=0.1$ and $1-{\beta}=0.8$ were all less than 20% (e.g., 12.91%, 18.46% and 19.65% for $AUC_t$ $C_{max}$ and $T_{max}$ respectively). The 90% confid,ence intervals were all within ${\pm}20%$(e.g., $-8.97{\sim}8.37$, $-11.58{\sim}13.22$ and $-16.23{\sim}10.17$ for $AUC_t$ $C_{max}$ and $T_{max}$, respectively). All of the above parameters ($1-{\beta}, {\Delta}$ and 90% confidence intervals) met the criteria of KFDA for bioequivalence, indicating that $Tigriri^{TM}$ capsule is bioequivalent to $Disgren^{TM}$ capsule.

• Biomolecules & Therapeutics
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• v.30 no.4
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• pp.309-319
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• 2022

Metabolic bone diseases are serious health issues worldwide, since several million individuals over the age of 50 are at risk of bone damage and should be worried about their bone health. One in every two women and one in every four men will break a bone during their lifetime due to a metabolic bone disease. Early detection, raising bone health awareness, and maintaining a balanced healthy diet may reduce the risk of skeletal fractures caused by metabolic bone diseases. This review compiles information on the most common metabolic bone diseases (osteoporosis, primary hyperparathyroidism, osteomalacia, and fluorosis disease) seen in the global population, including their symptoms, mechanisms, and causes, as well as discussing their prevention and the development of new drugs for treatment. A large amount of research literature suggests that balanced nutrition and balanced periodic supplementation of calcium, phosphate, and vitamin D can improve re-absorption and the regrowth of bones, and inhibit the formation of skeletal fractures, except in the case of hereditary bone diseases. Meanwhile, new and improved drug formulations, such as raloxifene, teriparatide, sclerostin, denosumab, and abaloparatide, have been successfully developed and administered as treatments for metabolic bone diseases, while others (romososumab and odanacatib) are in various stages of clinical trials.

• YAKHAK HOEJI
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• v.55 no.5
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• pp.426-431
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• 2011

This study was performed to investigate the current regulatory guidances of safety and efficacy evaluation for the development and approval of stereoisomeric drugs in US, EU, Canada and Japan. The important categories for the development of stereoisomeric drugs are classified as 1) development of a single enantiomer as a new active substance 2) development of a racemate as a new active substance 3) development of a new single enantiomer from an approved racemate. The regulatory documents adopted in major countries for the safety and efficacy evaluation of stereoisomeric drugs were investigated with the focus on three major categories mentioned above. For the regulatory approval of stereoisomeric drugs in Korea, it is expected that the investigated results obtained in this study will be useful for the basic materials to ensure the safety and efficacy of stereoisomeric drugs as well as the stereochemical issues in chiral drug development in domestic pharmaceutical company.

• Korean Journal of Clinical Pharmacy
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• v.34 no.1
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• pp.39-61
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• 2024

Background: The Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the Ministry of Food and Drug Safety (MFDS) have been implementing the expedited programs that promote the innovative approval of new medications to be used for serious diseases. The authors comprehensively investigated, analyzed, and compared the regulations and guidelines associated with the expedited programs. Methods: The expedited programs for innovative drug development and approval were searched from the homepages of FDA, EMA and MFDS. The detailed information on the regulations and guidelines associated with the programs was comprehensively extracted from various electronic repositories of each regulatory authority. The information on each program was analyzed, categorized, and compared from the points of benefits, applicability with scientific rationale, application procedure, and maintenance. Results: FDA's programs include Fast Track Designation, Breakthrough Therapy Designation, Priority Review Designation, and Accelerated Approval. EMA's regulation implements PRIority MEdicines (PRIME), Accelerated Assessment, Marketing Authorization under Exceptional Circumstances (MAEC), and Conditional Marketing Authorization (CMA). MFDS has a single Expedited Program. These programs are broadly categorized into those that 1) facilitate early and proactive communication with regulatory authorities, 2) shorten the review time after submitting a marketing application, and 3) temporarily approve a marketing authorization under certain conditions. Conclusion: Each expedited program requires a different level and amount of safety and efficacy evidence to be submitted to each regulatory authority. This article will likely provide the comprehensive information on which program provides scientific and regulatory advantages to be taken for innovative medication development.

• Bulletin of the Korean Chemical Society
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• v.33 no.1
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• pp.337-340
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• 2012

• Journal of Integrative Natural Science
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• v.16 no.4
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• pp.123-131
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• 2023

Breast cancer continues to pose a substantial worldwide health challenge, thereby requiring the development of innovative strategies to discover new therapeutic interventions. Signal Transducer and Activator of Transcription 3 (STAT-3) has been identified as a significant factor in the development of several types of cancer, including breast cancer. This is primarily attributed to its diverse functions in promoting tumour formation and conferring resistance to therapeutic interventions. This study presents an in silico drug repositioning approach that focuses on identifying specific inhibitors of STAT-3 for the purpose of treating breast cancer. We initially examined the structural and functional attributes of STAT-3, thereby elucidating its crucial involvement in cellular signalling cascades. A comprehensive virtual screening was performed on a diverse collection of drugs that have been approved by the FDA from zinc15 database. Various computational techniques, including molecular docking, cross docking, and cDFT analysis, were utilised in order to prioritise potential candidates. This prioritisation was based on their predicted binding energies and outer molecular orbital reactivity. The findings of our study have unveiled a Dihydroergotamine and Paritaprevir that have been approved by the FDA and exhibit considerable promise as selective inhibitors of STAT-3. In conclusion, the utilisation of our in silico drug repositioning approach presents a prompt and economically efficient method for the identification of potential compounds that warrant subsequent experimental validation as selective STAT-3 inhibitors in the context of breast cancer. The present study highlights the considerable potential of employing computational strategies to expedite the drug discovery process. Moreover, it provides valuable insights into novel avenues for targeted therapeutic interventions in the context of breast cancer treatment.

• Proceedings of the PSK Conference
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• 1999.06a
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• pp.30-60
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• 1999

In spite of many studies of The Korean Association of College of Pharmacy for improvement of the Korean pharmacy education and decrearing to change 4 year curriculum for pharmacy education to 6year curriculum from 1998 by The Ministry of Health and Wellfaire, there are many problems right now in view of the student-oriented education in front of the revolution program of The Ministry of Education. So the student-oriented reformation for pharmacy education in Korea was studied not only by observations of worldwide pharmacy education and pharmacy system, but also by 416 questionaires from many kinds of man and women such as pharmacists in drug store and hospital(159), administraters of The Ministry of Health and Wellfaire (59), professors in college of pharmacy (65), researchers in pharmaceutical company (31) and seniors in college of pharmacy(102).It shows that our Korean pharmacy education was a type of teacher-oriented education which is caused by the short time-education, a lots of subjects in the examination for pharmacy license and egoism of professors for their subjects, and so our teacher-oriented education have to change to the student-oriented education for the most function of pharmacist which is the pharmaceutical care for patients. For the preparing the clerkship/externship for one year, we have to change 4 year curriculum to 6 year curriculum for clinical pharmacy edu-cation, and also subjects of pharmacy in the national examination for pharmacy liciense have to reduce within 3-4 subjects of totally non-subject examination. The Korean Association of Collage of Pharmacy of Pan-pharmaceutical Revolution Association must purchase them and their program can be begun right now in spite of loss of the pharmacist supplement for 2 year and preparing the program of 6 years curriculum. Our teaching purposes of departments of pharmacy and manufacturing pharmacy were respectively clinical pharmacy, and development of new drug and compounding of many kinds of commercial drugs, but we have been not gone to their goals, respectively, because of short time-education for pharmacy as compared as world-wide pharmacy education containing the clerkship/externship and same twelve subjects in their examination for pharmacy license. Most function of pharmacist in Korea are the development of new drug, and social and administrative pharmacy in health care for patients, and so we have to teach them in the department of maunfacturing pharmacy.

• Research in Community and Public Health Nursing
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• v.24 no.2
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• pp.123-134
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• 2013

Purpose: The prescription drug list for primary treatment by community health practitioners has been maintained for 30 years without any modification. Thus, this study will suggest an improvement scheme of prescription drug list for primary health care posts through an analysis of drug use in those posts. Methods: A questionnaire survey was implemented with community health practitioners from April to June in 2012. A total of 1,249 copies were analyzed. As for the databases of drug use in the integrated information, a total of 154,229 diagnoses selected in the method of stratified cluster sampling from 39 primary health care posts' data were analyzed. We consulted some experts about the prescription medication list, and referred to the medication information on-line home page for up-to-date drug information. Results: This study ultimately suggests 77 prescription drug items for primary health care posts by eliminating 35 items and replacing 1 item from the original list, and adding 4 items to it. Conclusion: This study will provide basic data for revising the prescription drug list in primary health care posts by periodically reflecting adverse effects in the existing drugs, demographic and environmental changes, and development of new drugs.