• 한국임상약학회지
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• 제31권1호
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• pp.53-60
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• 2021

Objective: To gather the opinions of hands-on workers for successful introduction of the Development Safety Update Report (DSUR) according to a five-year comprehensive plan for clinical trial development [Ministry of Food and Drug Safety, 2019]. Methods: We conducted a survey on considerations that industry stakeholders may have related to the enforcement of the DSUR. A questionnaire was distributed among pharmacovigilance specialists from 13 pharmaceutical companies in South Korea on June 4, 2020. The questionnaire comprised two sections: 1) current status of the Drug Safety Data Management System and 2) considerations on the implementation and management of the DSUR. Results: All respondents have agreed the introduction of DSUR is inevitable for regulatory harmonization and safety of trial subject. However, most respondents (85%) felt concern about additional workload with DSUR implementation. They answered that format and operation system of DSUR should be harmonized with those of international standards and authorities need to minimize double burden due to related report. Conclusion: All respondents asserted that domestic DSUR should be harmonized with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) E2F guidelines. Respondents from global companies also suggested regulatory authorities allow DSUR written in English to replace Korean version considering their deadline for submission. Moreover, every respondent agreed regulatory authorities need delicate effort when implementing mandatory submission of DSUR to ensure that even small pharmaceutical companies with no experience in DSUR can comply with the system.

• 대한예방한의학회지
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• 제18권1호
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• pp.23-41
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• 2014

Objective : The purpose of this study was to lay the groundwork for understanding the details and scope of the legal definition of medicinal products, following the changes in the relevant laws and regulations. This will let readers properly understand the origins of the ongoing conflicts on herbal drugs and new drugs from natural products that are present in the medical field and the medical industry. Possible solutions are proposed in the end. Method : I analyzed the changes in definition of medicinal products since 1945 that have been used in relevant laws and regulations(i.e. Pharmaceutical Affairs Act) and drug approval process(i.e. New Drug Application and Investigational New Drug Application). Results : Legal definition of medicinal products has changed in accordance with the changes in the pharmaceutical industry, such as the establishment of dualistic medical and pharmaceutical System and the introduction of the substance patent. Due to those changes, boundaries of Western medicinal products and health food expanded, while those of herbal medicine products relatively downscaled. Conclusion : Legal definition of medicinal products-i.e. Herbal Drugs, Crude Drugs, and New Drugs from Natural Products-should be reestablished according to academic legitimacy and dualistic medical and pharmaceutical System.

• International Journal of Stem Cells
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• 제16권1호
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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.

• 약학회지
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• 제57권6호
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• pp.432-441
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• 2013

It's been almost 20 years since the adoption of Good Manufacturing Practices (GMP) in Korea since 1994. There have been big progresses in the GMP regulations and its implementations. 'New GMP' in 2008 has adopted validation, pre-approval GMP evaluation, annual quality review, etc.. Upon the submission of PIC/S (Pharmaceutical Inspection Cooperation Scheme) application by Korea's Ministry of Food and Drug Safety in April, 2012, Korea is facing new opportunity to level up Korea GMP regulations. As such, this study suggested GMP revision points by comparing and analyzing the differences between PIC/S GMP and Korea GMP. Those areas which GMP is not required such as radiopharmaceuticals and medical gases should adopt GMP. And independent GMP regulation is needed for Active Pharmaceutical Ingredients and investigational medicinal products. Also, those regulations shall be implemented in the higher level of legal status. Finally, rather than pursuing GMP harmonization only for PIC/S membership, GMP improvement in the long term shall be taken into consideration by reflecting current quality issues such as ICH Q8 (Pharmaceutical development), Q9 (Quality Risk Management) and Q10 (Pharmaceutical Quality System).

• 한국식품영양과학회:학술대회논문집
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• 한국식품영양과학회 2001년도 International Symposium on Food,Nutrition and Health for 21st Century
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• pp.52-60
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• 2001

Purpose: We performed a randomized, double-blind, placebo-controlled trial in mild to moderate myopia patients to evaluate the benefit of taking a nutrient supplement containing anthocyanoside oligomers for improving nocturnal visiual function and/or clinical symptoms. Methods: The subjects included have refractive error between -lD(Diopters) $\~$-8D in both eyes, symptoms of decreased night vision and asthenopia based on the scoring result of a pre-structured questionnaire, and abnormal results of mesopic contrast sensitivity(MCS) screening test showing abnormal curve of contrast sensitivity in the middle and high frequency level, between 6.0 and 30.0 CPD(Cycles per degree) at mesopic condition(-2$\~$0 log cd/$m^2$). Total 60 people who qualified the criteria above were enrolled and the subjects were instructed to take the investigational product (anthocyanoside or placebo) twice daily for a 4 week period. The enrolled subjects were investigated for nocturnal vision performance by MCS and clinical symptoms at their first visit and re-evaluated at post-intervention (4 weeks later). MCS was measured and improvement of contrast threshold level according to each CPD was calculated by subtracting initial values from final values. Age, refractive error, and MCS were compared between the placebo and anthocyanoside. Results: After 4 weeks of drug administration 22 of the anthocyanoside group showed symptom improvement compared to 1 of the placebo group (p=0.000). Contrast sensitivity levels according to each CPD before and after drug treatment showed significant improvement in the anthocyanoside group but not in the placebo group. Mean MCS change of anthocyanoside group is 2.41$\pm$1.91 which showed significant improvement compared to -0.40$\pm$2.47 of the placebo group(p=0.000). MCS changes of anthocyanoside group showed significant improvement compared to placebo group in all levels of CPD(p<0.05). During our investigation none of the subjects complained of specific side effects related to anthocyanoside use. Conclusion: Our results show that under careful selection of people with significant symptoms and definite MCS abnormalities, anthocyanoside oligomers may improve the subjective symptoms and objective MCS results.

• 한국과학교육학회지
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• 제15권2호
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• pp.173-184
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• 1995

The purpose of this study was to analyse the problems of 'Science Inquiry Experiment Contest(SIEC)' which was one of 8 programs of 'The 2nd Student Science Inquiry Olympic Meet(SSIOM)'. The results and conclusions of this study were as follows: 1. It needs to reconsider the role of practical work within science experiment because practical work skills form one of the mainstays in current science. But the assessment of students' laboratory skills in the contest was made little account of. It is necessary to remind of what it means to be 'good at science'. There are two aspects: knowing and doing. Both are important and, in certain respects, quite distinct. Doing science is more of a craft activity, relying more on craft skill and tacit knowledge than on the conscious application of explicit knowledge. Doing science is also divided into two aspects, 'process' and 'skill' by many science educators. 2. The report's and checklist's assessment items were overlapped. Therefore it was suggested that the checklist assessment items were set limit to the students' acts which can't be found in reports. It is important to identify those activities which produce a permanent assessable product, and those which do not. Skills connected with recording and reporting are likely to produce permanent evidence which can be evaluated after the experiment. Those connected with manipulative skills involving processes are more ephemeral and need to be assessed as they occur. The division of student's experimental skills will contribute to the accurate assess of student's scientific inquiry experimental ability. 3. There was a wide difference among the scores of one participant recorded by three evaluators. This means that there was no concrete discussion among the evaluators before the contest. Despite the items of the checklists were set by preparers of the contest experiments, the concrete discussions before the contest were necessary because students' experimental acts were very diverse. There is a variety of scientific skills. So it is necessary to assess the performance of individual students in a range of skills. But the most of the difficulties in the assessment of skills arise from the interaction between measurement and the use. To overcome the difficulties, not only must the mark needed for each skill be recorded, something which all examination groups obviously need, but also a description of the work that the student did when the skill was assessed must also be given, and not all groups need this. Fuller details must also be available for the purposes of moderation. This is a requirement for all students that there must be provision for samples of any end-product or other tangible form of evidence of candidates' work to be submitted for inspection. This is rather important if one is to be as fair as possible to students because, not only can this work be made available to moderators if necessary, but also it can be used to help in arriving at common standards among several evaluators, and in ensuring consistent standards from one evaluator over the assessment period. This need arises because there are problems associated with assessing different students on the same skill in different activities. 4. Most of the students' reports were assessed intuitively by the evaluators despite the assessment items were established concretely by preparers of the experiment. This result means that the evaluators were new to grasp the essence of the established assessment items of the experiment report and that the students' assessment scores were short of objectivity. Lastly, there are suggestions from the results and the conclusions. The students' experimental acts which were difficult to observe because they occur in a flash and which can be easily imitated should be excluded from the assessment items. Evaluators are likely to miss the time to observe the acts, and the students who are assessed later have more opportunity to practise the skill which is being assessed. It is necessary to be aware of these problems and try to reduce their influence or remove them. The skills and processes analysis has made a very useful checklist for scientific inquiry experiment assessment. But in itself it is of little value. It must be seen alongside the other vital attributes needed in the making of a good scientist, the affective aspects of commitment and confidence, the personal insights which come both through formal and informal learning, and the tacit knowledge that comes through experience, both structured and acquired in play. These four aspects must be continually interacting, in a flexible and individualistic way, throughout the scientific education of students. An increasing ability to be good at science, to be good at doing investigational practical work, will be gained through continually, successively, but often unpredictably, developing more experience, developing more insights, developing more skills, and producing more confidence and commitment.