• Journal of Pharmaceutical Investigation
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• v.34 no.3
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• pp.223-228
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• 2004

A new medical system was started in Korea in 2000 and pharmaceutical affairs law was revised in 2001. According to the revised law, generic substitution is permitted only to the drug products which are proven to be bioequivalent to the reference listed drugs. To expand the list of bioequivalence-proven drug products and to ensure the credibility of the therapeutic equivalence of generic drug are the hot issues in Korea. Also, the KFDA has a plan to revise the pharmaceutical affairs law that bioequivalence reports of all the generic prescription drug products should be submitted to the KFDA for drug approval after July in 2004. Therefore, it is increasing the necessity to develop the bioequivalence-demonstrating methods for specific drug substances and preparations which require to conduct food-effect bioavailability or bioequivalence study. There are some differences between US and Japanese guidances of food-effect bioavailability and bioequivalence studies. In this paper, we examined the recently published US guidance about food-effect study and it will be a reference to make our own guidance about food-effect bioavailability and bioequivalence guidances in Korea.

• Journal of Pharmaceutical Investigation
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• v.34 no.6
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• pp.529-540
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• 2004

After new medical system of separation of dispensary from medical practice was started in 2000 in Korea, to expand bioequivalence-proven drug products and to ensure the credibility of the therapeutic equivalence of generic drugs are hot issues in Korea. It will be obligatory to submit bioequivalence reports for getting licenses of all generic prescription drugs in the near future. Like other countries such as US and Japan, the KFDA also has a plan to re-evaluate the already approved drugs by bioequivalence studies. Therefore, it becomes more necessary to develop bioequivalence-demonstrating methods for specific preparations such as topical drug products among already approved drug products. There are some differences between US and Japanese guidances of bioequivalence studies of generic drug products for topical use. The information on Japanese guidance and the guidance's Q&As is already provided in our previous paper. In this paper, we examined the US guideline published in 1995 and compared with the Japanese guideline, which will give a useful information to make a guidance on bioequivalence studies of topical drug products in Korea.

• Journal of Pharmaceutical Investigation
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• v.34 no.4
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• pp.333-340
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• 2004

A new medical system of separation of dispensary from medical practice was started in 2000 in Korea. To expand bioequivalence-proven drug products and to ensure the credibility of the therapeutic equivalence of generic drug are hot issues in Korea. The KFDA also has a plan to revise the pharmaceutical affairs law that bioequivalence reports of all the generic prescription drugs should be submitted to the KFDA in the application for drug approval. Therefore, it becomes more necessary to develop bioequivalence-demonstrating methods for specific preparations such as topical drug products. There are some differences between US and Japanese guidances of bioequivalence studies of generic drug products for topical use. In this paper, we examined the recently published Japanese guideline, Guideline for Bioequivalence Studies of Generic Products For Topical Uses, and Q&A of the guideline, which will be references to make a guidance on bioequivalence studies of topical drug products in Korea.

• Journal of the Korea Academia-Industrial cooperation Society
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• v.19 no.6
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• pp.280-290
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• 2018

This study was a non-equivalence-based Quasi experimental study comparing the difference in communication ability, emotional intelligence (EQ), self-esteem, and interpersonal abilities between an experimental group with communication training and a non-control group. The subjects of the study were nurses working for D university hospital located in C city and comprised an experimental group of 21 people and a control group of 21 people. From April to May 2017, the experimental group took communication training programs, which were designed to improve communication capacity, emotional intelligence, self-esteem, and interpersonal ability for a total of four sessions (for 2 hours a week), and pre-post examination was conducted for the validity of the study. For data analysis, the SPSS for Windows 23 was used for the mean and standard deviation of pre-post tests, and U-test of the independent sample Mann-Whitney and the Wilcoxon code order test of the corresponding sample were carried out. The study results indicate that, compared with the control group, the experimental group showed communication capacity (Z=-3.361, p<.05), emotional intelligence (Z=-2.209, p<.05), self-esteem (Z=-1.633, p<.05), and interpersonal relationship (Z=-2.577, p<.05). After the communication training program, scores of communication capacity, emotional intelligence (EQ), self-esteem, and interpersonal competence of the experimental group increased significantly, and all hypotheses were supported. These results suggest that nurses' use of communication training experience in performing nursing work in a clinical setting would improve communication skills, emotional intelligence (EQ), self-esteem, and interpersonal skills and provide therapeutic communication and effective nursing, thereby enhancing patients' satisfaction and contributing to the improvement of nursing quality.

• Journal of the Korean Society of Radiology
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• v.18 no.3
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• pp.239-248
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• 2024

Radiation therapy uses high energy, which can have side effects on the human body. Therefore, it is important to ensure that the appropriate dose is set for irradiation and to have confidence in the radiation produced by the generator. The EPR/Alanine dosimetry system is characterized by water equivalence, dose response linearity, and low fading, which makes it useful for quality control of radiation therapy equipment. In this study, we compared the signal and dose response curves of EPR/Alanine dosimetry by mass of alanine using 6 MV energy of a LINAC. An alanine dosimeter and EPR spectrometer from Burker, and a LINAC from Elekta, were used. A dose response curve and a 1st order regression equation were constructed from the irradiated dose and the EPR signal from the alanine dosimeter. We compared the signal magnitude and dose response curve with mass and checked the confidence through the measurement uncertainty of the dose response curve. As a result, it was found that the magnitude of the EPR signal increased by about 1.3 times at 64.5 mg, and the sensitivity of the dose response curve increased as the mass increased. The measurement uncertainty was evaluated to be between 5.84 % and 8.93 %. Through this study, it is expected that the EPR/alanine dosimetry system can be applied to the quality assurance and quality control of a LINAC.