• Translational and Clinical Pharmacology
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• v.26 no.3
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• pp.111-114
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• 2018

Adding to the complexity of caring for critically ill patients is the fact that many of them have a creatinine clearance that exceeds $130mL/min/1.73m^2$. This phenomenon, termed augmented renal clearance (ARC), has only recently been widely recognized and its pathogenesis remains incompletely understood. However, ARC has been shown to result in increased dose requirements for drugs that are primarily eliminated by renal excretion, including many antimicrobial agents and enoxaparin. Recognition of ARC is hampered by the fact that the standard creatinine-based equations used to estimate renal function are not accurate in this clinical setting and the diagnosis is best established using both serum and urine creatinine measurements to calculate clearance. So a high index of clinical suspicion and awareness is usually required before this step is taken to confirm the diagnosis of ARC.

• Korean Journal of Clinical Pharmacy
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• v.28 no.2
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• pp.146-153
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• 2018

Objective: Multi-regional clinical trials have been widely used for accelerating global drug development by multinational pharmaceutical companies. In this study, we aimed to review and analyze the international trends in regulations and guidelines on multi-regional clinical trials by regulatory authorities and international organizations, such as International Conference on Harmonisation, for referring to policies, including development of domestic guidelines for multi-regional clinical trials. Methods: The policies, regulations, and guidelines published by the US Food and Drug Administration, European Medicines Agency, Pharmaceuticals and Medical Devices Agency (Japan), and China Food and Drug Administration were searched, and the International Conference on Harmonisation E17 draft guideline was reviewed. Results: The regulatory authorities in developed countries have developed and implemented regulations and guidelines on multi-regional clinical trials to promote simultaneous global drug development and evaluate the regional differences in drug safety and efficacy. International Conference on Harmonisation developed the draft guideline for planning/designing of multi-regional clinical trials in 2016, which recommends the general principles for strategy-related issues and design of multi-regional clinical trials, and for protocol-related issues, such as consideration of regional variability, subject selection, dose selection, endpoints, comparators, overall sample size, allocation to regions, collecting information on efficacy and safety, and statistical analysis. Conclusion: It is important to understand the international regulatory requirements for designing and planning of multi-regional clinical trials for global drug development. Moreover, it is necessary to prepare multi-regional clinical trial guidelines in accordance with the Korean regulation for clinical trials and drug administration.

• Journal of the Korean Society of Food Science and Nutrition
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• v.26 no.5
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• pp.983-992
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• 1997

During pregnancy and lactation, folate status is important because folate requirements increase during the periods as well as maternal folate status influences on pregnancy outcome and human milk folate; especially folate deficiency around periconceptional period may induce neural tube defects(NTDs) of fetus. There have been a plenty of evidences that maternal folate status deteriorates during pregnancy of fetus. There have been a plenty of evidences that maternal folate status deteriorates during pregnancy and lactation if folate needed is not sufficiently provided. The Public health Service of the United States recommends all child-bearing is not sufficiently provided. The Public Health Service of the United States recommends all child-bearing women to intake 0.4mg of folate daily, and the Food and Drug Administration the folate status of child-bearing women and to reduce the rate of occurrence of NTDs. Many authors have insisted that the current recommended dietary allowances of folate for Americans are too low to maintain good folate status. There are little data about Korean folate status including pregant and lactating women. A couple of reports indicated that the folate intakes of Korean pregant and lactating women are below the Korean RDAs of folate and serum folate levels of them are subnormal. The authors pregnant and lactating women. Therefore, it is worth to review the assessment methods of folate status of pregnant and lactating women, folate RDAs for them, the relationships between maternal folate status and pregnancy outcome as well as human milk folate, the methods to increase folate intake, and the problems of large dose of folic acid supplementatiion.

• Journal of Oral Medicine and Pain
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• v.30 no.2
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• pp.231-238
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• 2005

Anti-cancer drugs have been shown to target diverse cellular functions in mediation cell death in chemosensitive tumors. Most antineoplastic drugs used in chemotherapy of leukemias and solid tumors induce apoptosis in drug-sensitive target cells. However, the precise molecular requirements that are central for drug-induced cell death are largely unknown. Etoposide is used for the treatment of lung and testicular cancer. This study was performed to examine whether etoposide promote apoptosis in human oral squamous carcinoma cells (OSC9) as well as in lung and testicular cancer. Etoposide had a significant dose- and time-dependent inhibitory effect on the viability of OSC9 cells. TUNEL assay showed the positive reaction on condensed nuclei. Hoechst stain demonstrated that etoposide induced a change in nuclear morphology. The expression of p53 was increased at 48 hour, suggesting that the nuclear of OSC9 cell was damaged, thereby inducing apoptosis. Etoposide treatment induced caspase-3 cleavage and activation. Intact PARP protein 116-kDa and 85-kDa cleaved product were observed. The activated caspase-3 led cleavage of the PARP. These results demonstrate that etoposide-induced apoptosis in OSC9 cells is associated with caspase-3 activation.

• Journal of radiological science and technology
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• v.32 no.1
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• pp.1-15
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• 2009

Newly published IEC 60601-1-3 ; 2008 2nd Edition has two important meanings. First, Radiation Quality and Dose should make sure for safety of patient and staff in manufacturing diagnostic X-ray equipment. Second, it should be minimized of Leakage Radiation, Residual Radiation, and Stray Radiation. The requirement to make enactment or revision of national standard for diagnostic X-ray Equipment is as follows : 1. It should be adjusted the new standard to the recent IEC Publication under the consideration of the Korea medical circumstances. 2. For focus to the Radiation Safety, IEC 60601-1-3 (General requirements for radiation protection in diagnostic X-ray equipment) could be applied to the new regulation. It should be compact sentence. 3. A sudden Notification change should not be desired. It needs a enough time to make easy the circumstances.

• Progress in Medical Physics
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• v.19 no.4
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• pp.276-284
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• 2008

A computed tomography (CT) is a powerful system for the effectively fast and accurate diagnosis. The CT system, therefore, has used substantially and developed for improving the performance over the past decade, resulting in growing concerns over the radiation dose from the CT. Advanced CT techniques, such as a multidetector row CT scanner and dual energy or dual source CT, have led to new clinical applications that could result in further increases of radiation does for both patients and workers. The objective of this study was to review the international guidelines of the shielding requirements for a CT facility required for a new installation or when modifying an existing one. We used Google Search Engine to search the following keywords: computed tomography, CT regulation or shield or protection, dual energy or dual source CT, multidetector CT, CT radiation protection, and regulatory or legislation or regulation CT. In addition, we searched some special websites, that were provided for sources of radiation protection, shielding, and regulation, RSNA, AAPM, FDA, NIH, RCR, ICRP, IRPA, ICRP, IAEA, WHO (See in Table 1 for full explanations of the abbreviations). We finally summarized results of the investigated materials for each country. The shielding requirement of the CT room design was very well documented in the countries of Canada, United States of America, and United Kingdom. The wall thickness of the CT room could be obtained by the iso-exposure contour or the point source method. Most of documents provided by international organizations were explained in importance of radiation reduction in patients and workers. However, there were no directly-related documents of shielding and patient exposure dose for the dual energy CT system. Based international guidelines, the guideline of the CT room shielding and radiation reduction in patients and workers should be specified for all kinds of CT systems, included in the dual energy CT. We proposed some possible strategies in this paper.

• Journal of radiological science and technology
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• v.36 no.1
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• pp.1-10
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• 2013

IEC publications have applied in many countries all over the world such as Europe or Japan and these also have been published as in dustrial standards (KS) and notifications of Korea Food and Drug Administration (KFDA) in Korea. As the general standard of IEC 60601 series for medical electric (ME) equipment was revised as $3^{rd}$ edition in 2005, additional and particular standards have been revised or established newly. Under these circumstances, it is importance for manufacturing and assembling companies or authorized testing companies to understand the trend for revisions of IEC publications. Therefore in this study, the latest version of 3 IEC standards related to medical X-ray equipment : IEC 60601-2-44 for X-ray equipment for computed tomography (CT), IEC 60601-2-45 for mammographic X-ray equipment and IEC 60601-2-54 for X-ray equipment for radiography or radioscopy were covered and analyzed for trends and features accompanied by revision based on IEC 60601-1 $3^{rd}$ Ed. As KFDA notifications in force have referred to the particular standards based on 2nd edition of IEC 60601-1, those revised version of 3 particular standards were compared to KFDA notifications in force. The features of the latest standards applying IEC 60601-1 $3^{rd}$ Ed were shown as following: 1) Requirements for mechanical hazards, especially (motorized) moving parts were emphasized. 2) Indication and recording of patient dose were required. 3) Risk management process was introduced and enabled to monitor potential risks systematically. 4) DR system (digital radiography system) as well as analogue system (film-screen system) was included in the scope. Presently, KFDA will revise the notifications applying the particular standards based on IEC 60601-1 $3^{rd}$ Ed in a few years. Therefore the features of particular standards applying IEC 60601-1 $3^{rd}$ Ed was expected to help manufacturers, assemblers or testing companies of medical electric equipment understand IEC publications or KFDA notifications slated to be published.