• 약학회지
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• 제58권2호
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• pp.112-124
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• 2014

This study aimed to develop a regulation system for off-label drug use to secure the safe use of marketed drugs. We searched governmental documents for national and global regulating systems of off-label drug uses and a body of academic literature to explore current regulating trends. We included European Union, United Kingdom, United States of America, Australia and Japan, and critically reviewed the regulation of off-label drug use in four issues, which were a regulatory structure, safety control before and after off-label use, and information management. The findings of the present investigation called for several measures in off-label drug uses: enhancing prescribers' self-regulation, providing up-to-date information to prescribers for evidence-based practice and to patients for their informed consent, making evidence with scientific rigor, building an official registering process for off-label use in good quality and extending the role of pharmaceutical industry in pharmacovigilance. At last, we proposed a new system so as to regulate and evaluate off-label drug uses both at national and institutional level. In the new system, we suggested a clear-cut definition for clinical evidence that applicants would submit. We newly introduced an official 'Off-Label Drug Use Report' to evaluate the safety and clinical efficacy of a given off-label drug use. In addition, we developed an algorism of the regulation of off-label drug use within an institution to help set up the culture of evidence-based practices in off-label drug uses.

• 약학회지
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• 제56권1호
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• pp.60-65
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• 2012

This study examines factors associated with drug approvals and patent issues of the Korean pharmaceutical firms. The 22 firms were selected based on 2006 year's publicly noticed sales amount. Number of approved drugs was identified through Korea Food and Drug Administration and the information regarding the patents that each firm has issued during the year 2000~2006 was collected from the Korea Patent Office. The number of approved drugs has increased annually, especially after the introduction of substance patent system in 1987 and in 2000 again with the policy change into the separation of drug prescribing and dispensing practice. The number of initial approval of NCEs as well as the number of patents per firm decreased during the year 2000~2006. The 12 firms with larger revenue occupied more than 80% of the patents being issued. There was a positive relationship between share of prescription drugs out of approved drugs and the average number of patents issued. However, number of approved drugs did not show positive association with the number of patents issued per firm. Therefore, the study results imply that firms need to invest more in increasing number of approvals for their specific prescription drugs in order to achieve a good performance in the future.

• Journal of Pharmaceutical Investigation
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• 제26권3호
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• pp.221-232
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• 1996

An abrasive, calcium hydrogen phosphate dihydrate (DCPD), was synthesized in a Box-wilson experimental design by reactions between phosphoric acid and milk of lime, and calcium chloride and sodium phosphate solutions, and stabilized with TSPP and TMP. The optimum conditions for preparation of DCPD from phosphoric acid with milk of lime were such as; reaction temp.; $51.9^{\circ}C$, conc. of lime; 25.9%, conc. of phosphoric acd; 77.9%, drying temp.; $60.2^{\circ}C$ and final pH; 6.46. The physico-chemical and pharmaceutical properties of DCPD were showed as follows: glycerin absorption value(68 ml/100g), whiteness(99.5%), particle size(10.9 nm), pH(7.8), and set test(pass). XRD and SEM of DCPD indicated a monoclinic system crystallographically. $N_2$ adsorption isotherm curve by BET showed non porous type II form. The micromeritic parameters of DCPD showed that surface area was $3.27{\sim}4.6\;cm^{2}/g$ and pore volume, pore area and pore radius were negligible. The rheogram of the toothpaste containing DCPD showed pseudoplastic flow with yield value of 321, and thixotropic behavior forming hysteresis loop. These results meet the requirements as abrasive standard, and sythesized DCPD is expected as a good dental abrasive such as a high quality grade in practice.

• The Korean Journal of Physiology and Pharmacology
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• 제26권6호
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• pp.541-556
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• 2022

Myocardial fibrosis is a key link in the occurrence and development of diabetic cardiomyopathy. Its etiology is complex, and the effect of drugs is not good. Cardiomyocyte apoptosis is an important cause of myocardial fibrosis. The purpose of this study was to investigate the effect of gaseous signal molecule sulfur dioxide (SO₂) on diabetic myocardial fibrosis and its internal regulatory mechanism. Masson and TUNEL staining, Western-blot, transmission electron microscopy, RT-qPCR, immunofluorescence staining, and flow cytometry were used in the study, and the interstitial collagen deposition, autophagy, apoptosis, and changes in phosphatidylinositol 3-kinase (PI3K)/AKT pathways were evaluated from in vivo and in vitro experiments. The results showed that diabetic myocardial fibrosis was accompanied by cardiomyocyte apoptosis and down-regulation of endogenous SO₂-producing enzyme aspartate aminotransferase (AAT)_1/2. However, exogenous SO₂ donors could up-regulate AAT_1/2, reduce apoptosis of cardiomyocytes induced by diabetic rats or high glucose, inhibit phosphorylation of PI3K/AKT protein, up-regulate autophagy, and reduce interstitial collagen deposition. In conclusion, the results of this study suggest that the gaseous signal molecule SO₂ can inhibit the PI3K/AKT pathway to promote cytoprotective autophagy and inhibit cardiomyocyte apoptosis to improve myocardial fibrosis in diabetic rats. The results of this study are expected to provide new targets and intervention strategies for the prevention and treatment of diabetic cardiomyopathy.