• The Journal of Korean Medicine
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• v.31 no.3
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• pp.1-7
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• 2010

Objectives: To introduce to TKM scientific dose conversion methods of human to animal or animal to human for new drug investigations. Methods: We searched guidelines of the FDA and KFDA, and compared them with references for drug-dose conversion from various databases such as PubMed and Google. Then, we analyzed the potential issues and problems related to dose conversion in safety documentation of new herbal drugs based on our experiences during Investigational New Drug (IND) applications of TKM. Results: Dose conversion from human to animal or animal to human must be appropriately translated during new drug development. From time to time, investigators have some difficulty in determining the appropriate dose, because of misunderstandings of dose conversion, especially when they estimate starting dose in clinical or animal studies to investigate efficacy, toxicology and mechanisms. Therefore, education of appropriate dose calculation is crucial for investigators. The animal dose should not be extrapolated to humans by a simple conversion method based only on body weight, because many studies suggest the normalization method is based mainly on body surface area (BSA). In general, the body surface area seems to have good correlation among species with several parameters including oxygen utilization, caloric expenditure, basal metabolism, blood volume and circulating plasma protein. Likewise, a safety factor should be taken into consideration when deciding high dose in animal toxicology study. Conclusion: Herein, we explain the significance of dose conversion based on body surface area and starting dose estimation for clinical trials with safety factor.

• Korean Journal of Clinical Pharmacy
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• v.32 no.3
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• pp.166-177
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• 2022

Background: Recently clinical trials have expanded extensively in Korea; thus, ensuring the rights of subjects participating in clinical trials is imperative. Accordingly, national regulations on subject recruitment advertisement were enforced from October 25, 2018. In this study, the effect of this regulation was evaluated by analyzing the difference in the provision of information before and after enforcement of the regulation. Methods: Recruitment advertisements for clinical trial subjects 3 years before and after enforcement of the regulation were collated by the significance sampling approach. Print-based (newspapers, buses, and subways) and web-based (clinical trial center websites and online platforms) materials for recruitment in clinical trials of phase 1 to 4 for investigational drugs, medical devices, and oriental medicine were considered. Chi-square tests were conducted for inter-group comparisons. SPSS version 26 was employed for statistical analyses. Results: A total of 137 advertisements were collected comprising 60 pre- and 77 post-regulation enforcement. The overall rate of delivery of critical information in advertisements increased significantly from 47.5% before regulation to 93.2% after regulation enforcement. Particularly, details on expected adverse events augmented significantly (p<0.001). Benefits from participation in clinical trial reduced significantly from 88.3% to 70.1% (p<0.05). As the information provision amplified, the inclusion of professional terms increased. Conclusions: Enforcement of regulations has led to a surge in the amount of information and challenging terms contained in advertisements for recruiting subjects. Therefore, additional efforts are required by subjects to completely understand the information provided in the advertisements.

• Child Health Nursing Research
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• v.2 no.1
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• pp.112-126
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• 1996

The purpose of this study was to investigate the current status of the need of telephone call and to identify the status of nursing intervention through telephone. Head nurses of the pediatric nursing unit and a nurse of pediatric outpatient clinic wrote down the telephone record of calls by parents of children discharged from hospital from 7 am to 3 pm during the period of March to June, 1995. Content of 120 telephone calls but for 26 calls with incomplete record among 146 calls were analyzed into frequency of general characteristics, needs and nursing intervention. The needs of telephone call were identified and classified into 11 areas and analyzed into frequency of detailed content by 11 areas. Nursing intervention was identified and classified into 10 categories, and analyzed into frequency of detailed content by 10 categories. The findings of this study were as follows ; The need of telephone call was identified with nutritional state, medication, vital signs, language retardation, personal hygiene, vaccination, administration procedure, physical symptoms, follow up care management and others. The most frequent needs were physical symptoms and vaccination. A kind of food among nutrition dose of drugs among medication, fever among vital signs, cough among physical symptoms, and content of vaccination among vaccination was the most frequent needs. Nursing intervention through telephone was identified with instruction, knowledge offer, information offer, judgement, solicitation, referral and instruction, referral, connection, reassurance, reservation, and regulation. Instruction, knowledge offer and information offer was the most frequent nursing intervention by telephone call. Instruction was about a visit to hospital, a visit to nearby clinic, instruction about symptoms,, instruction about nursing care procedure, retelephoning and vaccination. Knowledge offer was about vaccination, knowledge related to medication, and dental care. Information offer and judgement was about vaccination and medication. Referral and instruction delivery was about instruction delivery following consultation to doctor, visit to emergency room and a visit to hospital following consultation to doctor. These results suggest that telephone call intervention program should be established as a field of extended pediatric nursing role in health care delivery system for the children.