• Bulletin of the Korean Chemical Society
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• v.33 no.5
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• pp.1681-1685
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• 2012

A sensitive liquid chromatography-tandem mass spectrometric (LC-MS/MS) method was developed to determine valproic acid in human red blood cell (RBC). It is important to measure the drug concentration of the RBC as well as that of the plasma because of drug partitioning for pharmacokinetic and pharmacodynamic study. The method was linear over the dynamic range of 1-100 ${\mu}g$/mL with a correlation coefficient $r$ = 0.9997. The linearity of this method was established from 1 to 100 ${\mu}g$/mL for valproic acid in red blood cell with accuracy and precision within 15% at all concentrations. The intra-run and inter-run assay accuracy and coefficient of variations are all within 15% for all QC samples prepared in plasma and red blood human samples. Then, valproic acid amount by protein precipitation in plasma was quantified by LC-MS/MS mass spectrometry. The distribution ratio of VPA in RBC and plasma was analyzed by clinical samples. Based on measurement of the valproic acid in human red blood cell, this method has been applied to clinical research for study of distribution ratio of valproic acid in blood.

• The Journal of KAIRB
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• v.5 no.1
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• pp.14-20
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• 2023

Purpose: To obtain fundamental data on selection tools for an internal audit and develop a new guideline. We scored the indicated points from the internal audit, identified the research progress and problems that occurred, and confirmed the validity of the risk factors involved. Methods: Of the 63 internal audits conducted by Keimyung University Dongsan Hospital from 2014 to 2021, we analyzed 55 clinical trials with an inspection checklist. We excluded 8 that failed to transfer data and refused to comply with the internal audit. The statistical summary of the collected data was verified and interpreted by using frequency analysis and a chi-square test. Result: Of total 55 cases included in the internal audit, sponsor-initiated trial (SIT) was 63.6% (vs. investigator-initiated trial [IIT]), clinical trial for investigational drug was 71.0% (vs. nonclinical or clinical trial for investigational device), domestic multicenter trial was 60.0% (vs. single center or multinational multicenter trial), and trial requisition for MFDS approval was 69.1% (vs. exception for MFDS approval). The 10 areas of the clinical trial inspection checklist (reports, protection of subjects, compliance with protocols, records, management of investigational drug and/or device, delegation of duties, qualification of investigators, management of specimen, contract-agreement and approval of protocols, and preservation of recorded documents) were weighted between 2 to 5 points. The average of the total points was 16.09±13.2 and 20 clinical trials were above the average. As a result of comparing the average of the total points weighted by year, the highest score was in 2020. The 4 factors that play significant roles in determining the internal quality were (1) principal subjects that initiated the clinical trials (p=0.049), (2) type (p=0.003), (3) phase of clinical trials (p=0.024), and (4) number of registered subjects reported at the time of continuing deliberation (p=0.019). Of the 10 areas of the clinical trial inspection checklist, 'record' was the most inappropriate and insufficient. We found more indicated points; the quality of performance declined in IIT, nonclinical trials, and other clinical trials that were not in phase I1-IV4, and the study of more than 30 registered subjects at the time of continuing review. Conclusion: If an institution has an internal audit selection tool that reflects the aforementioned risk factors, it will be possible to effectively manage high-risk studies; thereby, contributing to an efficient internal audit and improving the quality of clinical trials.

• Analytical Science and Technology
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• v.25 no.1
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• pp.19-24
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• 2012

Liquid chromatography-tandem mass spectrometry (LC-MS/MS) method has been developed and validated for the quantitative determination of ertapenem in human plasma and urine. After addition of internal standard (ceftazidime), plasma and urine was diluted with methanol and analyzed by LC-MS/MS. Using MS/MS with multiple reaction monitoring (MRM) mode, ertapenem were selectively detected without severeinterference from human plasma and urine. The standard calibration curve for ertapenem was linear ($r^2$= 0.9996)over the concentration range 1~100 ${\mu}g/mL$ in human plasma. The intra- and inter-day precision over the concentration range of ertapenem was lower than 8.9% (correlation of variance, CV), and accuracy was between 97.2~106.2%. On the other hand, it was showed good relationship ($r^2$= 0.9992) and the precision (intra- and inter-day) over the concentration range of ertapenem was lower than CV 7.2%, and accuracy was between 97.9~111.6% for urine. This method has been successfully applied to the pharmacokinetic study of ertapenem in human plasma and urine.

• Journal of the Society of Cosmetic Scientists of Korea
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• v.49 no.4
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• pp.349-354
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• 2023

Sunscreen is a product that protects against ultraviolet rays by blocking and scattering ultraviolet rays, and has now become a daily necessity beyond cosmetics. Applying sunscreen is a common and easy way to prevent skin damage caused by ultraviolet rays. Due to its significance, the evaluation of sunscreen has evolved since its regulation by the FDA in 1978, progressing to standardized methods established by ISO. Additionally, to assess the loss of sunscreen due to activities such as water exposure or sweating, the Ministry of Food and Drug Safety in Korea and ISO have established protocols for evaluating the water-resistant sun protection factor (SPF). However, existing evaluations of water resistance have been mainly confined to test methods involving plain water, and methods accounting for the impact of seawater during activities like beach leisure, sports, and recreation are yet to be established. Based on the existing guidelines for testing the water-resistant UV protection index, this study compared the water-resistant UV protection index in water, artificial seawater (salt water) and natural seawater (sea water) to evaluate the UV protection index in real-world situations such as marine leisure, sports, and leisure activities. Through these results, we were able to compare the differences between water resistance sun protection index tests in ordinary water, artificial seawater, and natural seawater, and suggest a method for water resistance sun protection index tests using natural seawater.

• Korean Journal of Biological Psychiatry
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• v.19 no.4
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• pp.153-158
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• 2012

Understanding of a clinical trial is essential in developing clinical guideline and adopting evidence based practice. In designing and executing clinical trials, following ethical requirements should be considered : social value, scientific validity, fair subject selection, informed consent, favorable risk-benefit ratio, institutional review board, and respect for human subjects. According to the stage of drug development, purpose of trials, accumulated scientific data, clinical trials for drug development are classified as phase 1, 2, 3, and 4. Phases of clinical trials can be overlapped and the judgment of entering into the next phase should be considered highly strategically. In reading, evaluating and interpreting clinical trial reports, various skills and challenges exist. Patient sample composition, trial duration, selection of endpoints, responders and non-responders, placebo effect, patient recruitment, and extrapolation to the real world are the examples of those challenges. Treatment success will come from the well balanced approach of evidence based decision making and consideration of specific single case.

• The Korean Society of Law and Medicine
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• v.15 no.1
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• pp.211-237
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• 2014

Because of unpredictability and high possibility of abnormal results by clinical trials compared to general medical behaviors, a procedure for ensuring with sufficient explanations by investigators must be secured. Therefore, in a sequence of clinical trials, what kinds of scope, stage, and method of explanations provided by investigators, including doctors or researchers, to trial subjects are closely related to the compensation for damages by violation of liability for explanation. In case of application of clinical trials to patients who have critical illness such as cancer, issues of "Quality of Life" regarding trial subjects, cancer patients, should be discussed. Especially, in case of clinical trials for terminal cancer patients, the right of subjects' self-determination, which is a fundamental principle in medical behaviors, should be discussed. The right of self-determination includes participation in clinical trials for the possibility of life-sustaining even a little bit, or no participation in clinical trials in order to have a time for completing the rest of his life. Like this, if the extent and scope of explanations related to the issues of "Quality of Life" are raised as main issues, the evaluation of "Quality of Life", should be a prerequisite. In many occasions, realistically, despite bad results such as deaths or serious adverse drug reactions after clinical trials, it may not be easy for compensating to trial subjects or their survivors, who requested civil compensation for damage. Futhermore, in abnormal results after concealment of clinical trials or performance of clinical trials without permission, and in the case of trial subjects' failures of proving proximate cause between the clinical trials and abnormal results, problematic results such as no protection to the trial subjects could be occurred. In performing clinical trials, investigators should provide sufficient explanations for trial subjects and secure voluntary informed consents from the trial subjects. Therefore, clinical trials without trial subjects' permissions and the informed consent process violate trial subjects' rights of self-determination, and the investigators shall be liable for compensation for damages. Then, issues might be addressed are what are essential contents of patients' "rights of self-determination" infringed by clinical trials without subjects' permissions. Two perspectives about patients' rights of self-determination might be considered. One perspective regards physical distress of patients (subjects) from therapies without sufficient explanations as the crux of the matter. The other perspective regards infringement of human dignity caused by being subjects without permission as the crux of the matter irrespective of risks' big and small influences. This research follows perspective of the latter. Forming constant fiduciary relation between investigators (doctors) and subjects (patients) pursuant medical contracts, and in accordance with this fiduciary relation, subjects, who are patients, have expectations of explanations and treatments by the best ways. If doctors and patients set this forth as a premise, doctors should assume civil liability when doctors infringe patients' expectations.

• The Korean Society of Law and Medicine
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• v.17 no.2
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• pp.125-144
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• 2016

All forms of Clinical trial should be fully equipped with protection systems for experimental subjects considering their uncertainty and various risks. Existing laws have some regulations in pharmaceutical affairs act and medical device act. Nonetheless, there is a limit to protect the subjects considering law objective to perform administration of medicine. Furthermore, the clinical trial on minor has no direct regulations in pharmaceutical affairs act, but prescribes certain portion in clinical trial assessment guideline on infants or medicine clinical trial management standard, however there is a limit because that is just recommendation not having legal effectiveness. The legislative solution would be possible for legal problems of clinical trial on minor by examining treatment system on minor in organ transplant act and clinical trial on minor in other foreign laws stronger than usual medical practice in terms of degree of human body invasion. I suppose that the control system of clinical trial being done focusing on the pharmaceutical affairs act, medical device act and other guidelines in existing laws system should be resolved by legislating 'trial subject protection law', in addition, this would be well balanced in organ transplant act on protection system of minor organ donors. Furthermore, the judgement on the consent ability and spontaneity in clinical trial on minor should be judged considering maturity and mentality of minor by clinical trial institutional review board based on legislative solution mentioned above.

• Journal of Physiology & Pathology in Korean Medicine
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• v.32 no.4
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• pp.271-276
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• 2018

The purpose of pilot clinical trial is to evaluate the efficacy and safety of acupuncture therapy on TEWL(Transepidermal Water Loss) and skin hydration. A total of 36 human who visited Dongshin University Oriental Medical Center from October 2nd, 2015 to July 31st, 2016 were included in the pilot clinical trial. Acupuncture therapy was performed at Gokji(LI11) and Daechu(GV14). We observed change of TEWL(Transepidermal Water Loss), skin hydration before and after acupuncture therapy. In the primary endpoint, index of TEWL showed a statistically significant decline($8.01{\pm}2.55{\rightarrow}6.58{\pm}1.97g/h/m2$, $7.40{\pm}2.65{\rightarrow}4.99{\pm}1.89g/h/m2$). Index of skin hydration showed statistical significance($52.83{\pm}6.53{\rightarrow}56.82{\pm}7.24$, $63.50{\pm}8.57{\rightarrow}64.96{\pm}8.48$). To evaluate the safety, vital sign check were conducted and showed no statistically significant result. And there were no severe adverse events during this study. According to the above pilot clinical trial, it is suggested acupuncture therapy were effective for skin moisturizing.

• Journal of Korean society of Dental Hygiene
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• v.14 no.6
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• pp.839-847
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• 2014

Objectives: The purpose of the study was to investigate the perception of clinical trials of dental hygienist. Methods: A self-reported questionnaire was filled out by 126 dental hygienists in Seoul, Kyonggi and other area from October 1 to November 15, 2012. The instrument of the study was adapted from Jung and reconstructed. The questionnaire consisted of general characteristics of the subjects(9 questions) and recognition for clinical trials(10 questions). Recognition for clinical trials instrument included recognition for clinical trial conception(2 questions), objective recognition(5 questions), and subjective recognition for clinical trial(3 questions). The instrument was score by Likert 5 scale and Cronbach alpha was 0.936 in the study. Data were analyzed by SPSS 20.0 program and set at p<0.05. Independent t-test, chi-square test, one way ANOVA, and post-hoc Duncan test were done. Results: Those who had higher ages and higher education tended to have longer clinical careers(p<0.05). There was a significant difference in clinical trials between the level of education, clinical dental hygienists and professors. The differences in problem perception for activation of clinical trial according to workplace appeared to lack of publicity and inadequacy of facilities(p<0.05). Conclusions: To improve the perception of the clinical trials in dental hygienists, it is necessary to prepare the human resources programs, the additional curricula, continuing education courses and active publicity.

• International Journal of Stem Cells
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• v.16 no.1
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• pp.16-26
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• 2023

Despite long-term research achievements, the development of cell therapy (CT) products remains challenging. This is because the risks experienced by the subject and therapeutic effects in the clinical trial stage are unclear due to the various uncertainties of CT when administered to humans. Nevertheless, as autologous cell products for systemic administration have recently been approved for marketing, CT product development is accelerating, particularly in the field of unmet medical needs. The human experience of CT remains insufficient compared with other classes of pharmaceuticals, while there are countless products for clinical development. Therefore, for many sponsors, understanding the rationale of human application of an investigational product based on the consensus and improving the ability to apply it appropriately for CT are necessary. Thus, defining the level of evidence for safety and efficacy fundamentally required for initiating the clinical development and preparing it using a reliable method for CT. Furthermore, the expertise should be strengthened in the design of the first-in-human trial, such as the starting dose and dose-escalation plan, based on a sufficiently acceptable rationale. Cultivating development professionals with these skills will increase the opportunity for more candidates to enter the clinical development phase.