• The Korean Society of Law and Medicine
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• v.22 no.4
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• pp.159-184
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• 2021

The significance of the enactment of the 「Act On The Safety Of And Support For Advanced Regenerative Medicine And Advanced Biological Products」 is to break away from the regulation of the Pharmaceutical Affairs Act and expand patient treatment opportunities through a medical technology approach to regenerative medicine, which is essentially a medical practice called 'transplantation'. However, more than a year after the law was enacted, clinical study has not been activated, with not a single high-risk study approved by the Ministry of Food and Drug Safety being approved. The reason is that despite the legal purpose of expanding patient treatment opportunities, the data requirements for clinical study approval are set in connection with drug development despite the insufficient legal basis, making it difficult for many researchers to meet the data requirements. Prior to the enactment of the Act, submitted data for clinical study on cell therapy products within the Pharmaceutical Affairs Act were cosiderably exempted from quality and non-clinical test data, but with the enforcement of the Advanced Regenerative Bio Act, quality and non-clinical test data are required in accordance with pharmaceuticals when applying for approval of a clinical study plan. To rectify this, when considering the identity of clinical study on advanced regenerative medicine to expand treatment opportunities, recognize that there are limitations in connection with drug development. And it is necessary to preserve the identity of clinical study on advanced regenerative medicine, and on the other hand, in the case of drug product approval, clinical study results should be utilized while specifying usage requirements. Therefore, with the power of the market and the voluntary motive of the clinical researcher, it is necessary to prepare the necessary data by themselves rather than the basic requirements for clinical study approval.

• Proceedings of the PSK Conference
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• 2002.10a
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• pp.432-432
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• 2002

Drug used in hospital is allowed marketing through after pharmacological and toxicological tests using various animals and clinical test of human in developing state. But as pre-marketing clinical study take short period with relatively a few of patients and strict selection criteria of people, pediatric, geriatric. pregnancy, liver and kidney patients may be excluded. As the safety of drug isn't completely evaluated before launching. it is important to collect and evaluate drug adverse reaction newly reported by medical practitioners and pharmacists. (omitted)

• Journal of Periodontal and Implant Science
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• v.43 no.6
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• pp.262-268
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• 2013

The use of dental implants has become a mainstay of rehabilitative and restorative dentistry. With an impressive clinical success rate, there remain a few minor clinical issues with the use of implants such as peri-implant mucositis and peri-implantitis. The use of laser technology with implants has a fascinating breadth of applications, beginning from their precision manufacturing to clinical uses for surgical site preparation, reducing pain and inflammation, and promoting osseointegration and tissue regeneration. This latter aspect is the focus of this review, which outlines various studies of implants and laser therapy in animal models. The use of low level light therapy or photobiomodulation has demonstrated its efficacy in these studies. Besides more research studies to understand its molecular mechanisms, significant efforts are needed to standardize the clinical dosing and delivery protocols for laser therapy to ensure the maximal efficacy and safety of this potent clinical tool for photobiomodulation.

• 대한임상약리학회:학술대회논문집
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• 1999.12a
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• pp.44-44
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• 1999

• Journal of Korean Dental Science
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• v.15 no.2
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• pp.112-120
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• 2022

In this article, the contemporary root canal treatment procedure using nickel-titanium (NiTi) instruments was reviewed to understand the correlations between the properties of files and safety of the clinical usage. Literatures were reviewed according to the process of clinical procedure of the root canal preparation, mainly for shaping during orifice flaring, glide-path preparation, and main canal instrumentation. Considering the reasons for NiTi file fracture, clinically implacable issues and ideas were discussed to reduce the fracture risk and increase clinical efficiency of the NiTi file systems. Various kinds of NiTi file systems have their own characteristics and properties given from their geometries and heat treatments and so on. Proper selection and careful usage of the NiTi file systems may reduce the risk of file fracture and increase the efficiency of NiTi file systems. Understanding of the clinical implications from the mechanical properties and characteristics of the engine driven NiTi instruments may decrease the risk of NiTi file fractures and increase the success rate in root canal treatment.

• Clinical and Experimental Reproductive Medicine
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• v.50 no.4
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• pp.223-229
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• 2023

Endometriosis is characterized by the implantation of endometrial cells outside the uterus. This hormone-dependent disease is highly prevalent among women of reproductive age. Clinical symptoms of endometriosis include dysmenorrhea, pelvic pain, and infertility, which can negatively impact the overall quality of life of those affected. The medical treatment of endometriosis serves as an important therapeutic option, aimed at alleviating pain associated with the condition and suppressing the growth of endometriotic lesions. As such, it is employed as an adjuvant therapy following surgery or an empirical treatment after the clinical diagnosis of endometriosis. Dienogest, a fourth-generation progestin, has received approval for the treatment of endometriosis in many countries. A growing body of evidence has demonstrated its efficacy in managing endometriosis-associated pain, preventing symptoms, and reducing lesion recurrence. In this review, we examine the clinical efficacy, safety, and tolerability of dienogest in treating endometriosis. We also provide updated findings, drawing from clinical studies that focus on the long-term use of this medication in patients with endometriosis.

• The Korean Journal of Pesticide Science
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• v.15 no.3
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• pp.289-297
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• 2011

As part of safety evaluation of 2A (amono acid), PAT (phosphinotricin Acetyl-transferase), CtrI (Carotene desaturase) and PSY (phytoene synthase), the expressed proteins inserted to ${\beta}$-carotene Biofortified rice were tested for antigencity test. As a result, the group of administering high-concentration PAT, the expressed protein, showed a great content of total WBC; however, other expressed proteins did not show much difference. Against ASA (Active Systemic Anaphylaxis) test, the group of administering high-concentration PAT, the expressed protein, showed mild or medium degree of symptoms, but there was no dead entity. According to the result of the PCA (Passive Cutaneous Anaphylaxis test), the group of administering high-concentration PAT, 2A, PSY, and mixture of expressed proteins indicated positive response in low anti-serum concentration, and the group of administering the clinical concentration of mixture indicated mild positive response. However, because the group of administering the clinical concentration of expressed proteins, PAT, 2A, PSY, and CtrI, did not show positive response, it is thought that IgE is not generated. Further studies are needed to verify the safety of ${\beta}$-carotene Biofortified rice.

• Journal of Korean society of Dental Hygiene
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• v.16 no.2
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• pp.215-224
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• 2016

Objectives: The purpose of the study was to investigate the related factors of performance of radiation safety management in dental hygienists. Methods: A self-reported questionnaire was completed by 183 dental hygienists using dental radiography in 110 dental clinics in G area by convenience sampling methods. The questionnaire consisted of general characteristics of the subjects, radiation-related characteristics, and performance and management of radiation safety. Results: Performance score of radiation safety management was $35.71{\pm}12.49$ in dental hygienists. The performance score of radiation safety management were associated with sex, numbers of dental hygienists, the average numbers of admitted patients per day, the total clinical experience, existence of manual for radiation safety management and perceived need for education of radiation safety management. Conclusions: The performance score was relatively low. The performance score was associated with radiation safety manual and safety equipment. The preparation of radiation protective environment and equipment will improve the performance of radiation safety management in dental hygienists.

• Journal of Korean Clinical Nursing Research
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• v.17 no.2
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• pp.138-149
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• 2011

Purpose: The objective of this research was to explore levels of patient safety and safe nursing activities depending on the level of nurse staffing, in order to provide effective management of nurse personnel. Methods: The research was conducted with 455 nurses from eight hospitals in B city. Data were collected according to the level of nurse personnel from second (nurse vs. patient ratio of 2.0-2.5) to fifth (ratio of 3.5-4.0) rank. The survey tools were, 'Questionnaire on Patient Safety, a Hospital Survey on Patient Safety Culture developed by AHRQ (2007), and 'Questionnaire on Patient Safety Nursing Act, in which the questions were selected from nursing-related items (Medication 6 & Safety Nursing Assurance Act 4) in the Safety Evaluation developed by Evaluation Institute of Medical Institution. Data were analyzed with SPSS PC 12.0 program using descriptive statistics, $x^2$ test, ANCOVA and $Scheff{\grave{e}}$. Results: The nurses' overall cognition level on patient safety and safe nursing activities showed that nurses who are in the second and third rank had higher scores than those in lower ranks. Conclusion: The results of this study indicate that hospitals need a higher ratio level for nurse personnel in order to assure patient safety and safe nursing activities.

• Korean Journal of Adult Nursing
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• v.24 no.6
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• pp.569-579
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• 2012

Purpose: The purpose of this study was to investigate the relationship between drug dosage calculation error prevention competence and medication safety organizational climate. Methods: We surveyed 207 nurses from 15 hospitals. An assessment survey was designed to assess the medication safety organizational climate which consisted of four subcategories including medication safety cultures, medication safety initiatives, medication error communication, and medication error management competence. The drug dosage calculation error prevention competence contains two subcategories; Dosage calculation habits and ability. The data were collected from July to August 2011. Descriptive statistics, t-test, ANOVA, partial Pearson correlation coefficient, canonical correlation were used. Results: Organizational climate was related to dosage calculation error prevention competence with two significant canonical variables. The first canonical correlation coefficient was .53 (Wilks' ${\lambda}$=0.71, df=8, p<.001) and that of the second was .21 (Wilks' ${\lambda}$=0.96, df=3, p=.027). The first variate indicated higher perception of medication safety cultures, safety initiatives, error communication and error management competence were related to better dosage calculation habits. The second variate showed higher perception of medication safety cultures and lower medication error management competence were related to higher calculation ability. Conclusion: Continuous supporting strategies for medication safety organizational climate should be implemented to improve drug dosage calculation habits.