• Toxicological Research
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• 제17권
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• pp.185-188
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• 2001

Genetically modified foods and food additives are derived from organisms that have been inserted foreign genetic materials by recombinant DNA techniques to improve the quality or any other pur-poses. The problems such as toxicity, allergenicity and antibiotics resistance in the safety of genetically modified foods are usually concerned. In Korea, the safety of foods is ensured by the Food Sanitation Act. Although there is no specific provision regarding the genetically modified foods in it, any foods that might cause negative effect(s) on public health or human life are prohibited to sell in the market. In order to systematically evaluate safety of genetically modified foods, the Korea Food and Drug Administration (KFDA) promulgated "Guidelines regarding review of safety assessment data for genetically modified foods and food additives (KFDA Notification 1999-46)". The objectives of these guidelines are to ensure safety of genetically modified foods and food additives. In order to evaluate the safety of genetically modified foods. KFDA operates a special expert committee composed by experts from government, universities, research institutes. and consumer's unions. Recently. manufacturers and consumers are interested in the issues on safety and labeling of genetically modified foods, because of increment of imported genetically modified crops and processed foods. Since government and consumers unions have different viewpoints, their positions regarding the issue are different each other. Therefore, the regulation of labeling on genetically modified foods is prepared and should be enforced at July 2000 in Korea. in Korea.

• 한국응용약물학회:학술대회논문집
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• 한국응용약물학회 2006년도 Proceedings of The Convention
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• pp.23-39
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• 2006

The application of the knowledge from the Human Genome Project to clinical medicine will be through both industrial drug development and the application of pharmacogenomics (PG) to patient care. The slow uptake of clinical innovations into clinical practice can be frustrating, but understanding the history of acceptance and sustaining medical innovation is critically important to position PG to succeed. This primarily means that PG tests must have legitimacy; they must be thoroughly validated, must be cost-effective, must be widely accepted by medical practitioners, must be supported by public policy, and must have a way of being easily incorporated into current medical practice. They must also lead to actionalble decisions by health care providers for their patients. Innovative PG assays should be tested in the best US laboratories, and reimbursement for testing must be accepted at the federal and state level. The companies providing these PG tests should be capable of supporting the interpretation and use of the test throughout medical practice. Advances such as the addition of PG information to drug labeling and the routine use of validated biomarkers to determine choice of cancer chemotherapy have been made. The PG research community must pay attention to the principles that have been previously described for acceptance and sustaining medical innovations in order for PG to be widely accepted in clinical medical practice.

• Biomolecules & Therapeutics
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• 제15권1호
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• pp.1-6
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• 2007

The application of the knowledge from the Human Genome Project to clinical medicine will be through both industrial drug development and the application of pharmacogenomics (PG) to patient care. The slow uptake of clinical innovations into clinical practice can be frustrating, but understanding the history of acceptance and sustaining medical innovation is critically important to position PG to succeed. This primarily means that PG tests must have legitimacy; they must be thoroughly validated, must be cost-effective, must be widely accepted by medical practitioners, must be supported by public policy, and must have a way of being easily incorporated into current medical practice. They must also lead to actionalble decisions by health care providers for their patients. Innovative PG assays should be tested in the best US laboratories, and reimbursement for testing must be accepted at the federal and state level. The companies providing these PG tests should be capable of sup-porting the interpretation and use of the test throughout medical practice. Advances such as the addition of PG information to drug labeling and the routine use of validated biomarkers to determine choice of cancer chemotherapy have been made. The PG research community must pay attention to the principles that have been previously described for acceptance and sustaining medical innovations in order for PG to be widely accepted in clinical medical practice.

• Journal of the Korean Academy of Child and Adolescent Psychiatry
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• 제22권2호
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• pp.67-73
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• 2011

The purpose of licensing system is to ensure that the medicines are examined for safety, efficacy and quality. Nevertheless, off-label or unlicensed drug usages in pediatric practice is widespread in Korea and worldwide. Psychotropics are one of the most commonly used off-label or unlicensed drugs. The most valid approach to face this dilemma will be to have more evidences from pediatric pharmacological studies. Clinicians, in addition, need to monitor closely their off-label or unlicensed drug prescriptions to minimize the trial and error in practice. Researchers should publish their experiences and provide guidelines. Pharmaceutical companies, regulatory authorities, and consumer organizations should endeavor altogether for the children's right to get safe and efficacious drugs as adults do. Here, the definition as well as the current status of off-label and unlicensed drug prescriptions will be introduced. Critical issues regarding the off label drugs are discussed. In addition, I will describe the present condition as to the off-label and unlicensed drugs in child and adolescent psychiatry and the authorization process of off-label drug prescription in Korea. Lastly, direction we should like to take in this field will be mentioned.

• 한국임상약학회지
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• 제32권3호
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• pp.226-237
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• 2022

Background: Monoclonal antibodies for the treatment of patients with different types of cancer, such as cetuximab, have been widely used for the past 10 years in oncology. Although drug information package insert contains some representative adverse events which were observed in the clinical trials for drug approval, the overall adverse event patterns on the real-world cetuximab use were less investigated. Also, there have been no published papers that deal with the full spectrums of adverse drug events of cetuximab using national-wide drug safety surveillance systems. Methods: In this study, we detected new adverse event signals of cetuximab in the Korea Adverse Event Reporting System (KAERS) by utilizing proportional reporting ratios, reporting odds ratios, and information components indices. Results: The KAERS database included 869,819 spontaneous adverse event reports, among which 2,116 reports contained cetuximab. We compared the labels of cetuximab among the United States, European Union, Australia, Japan, and Korea to compare the current labeling information and newly detected signals of our study. Some of the signals including hyperkeratosis, tenesmus, folliculitis, esophagitis, neuralgia, disseminated intravascular coagulopathy, and skin/throat tightness were not labeled in the five countries. Conclusion: We identified new signals that were not known at the time of market approval.

• 한국약용작물학회:학술대회논문집
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• 한국약용작물학회 2006년도 Proceedings of The Convention of The Korean Society of Applied Pharmacology
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• pp.23-39
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• 2006

The application of the knowledge from the Human Genome Project to clinical medicine will be through both industrial drug development and the application of pharmacogenomics (PG) to patient care. The slow uptake of clinical innovations into clinical practice can be frustrating, but understanding the history of acceptance and sustaining medical innovation is critically important to position PG to succeed. This primarily means that PG tests must have legitimacy; they must be thoroughly validated, must be cost-effective, must be widely accepted by medical practitioners, must be supported by public policy, and must have a way of being easily incorporated into current medical practice. They must also lead to actionalble decisions by health care providers for their patients. Innovative PG assays should be tested in the best US laboratories, and reimbursement for testing must be accepted at the federal and state level. The companies providing these PG tests should be capable of supporting the interpretation and use of the test throughout medical practice. Advances such as the addition of PG information to drug labeling and the routine use of validated biomarkers to determine choice of cancer chemotherapy have been made. The PG research community must pay attention to the principles that have been previously described for acceptance and sustaining medical innovations in order for PG to be widely accepted in clinical medical practice.

• 약학회지
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• 제56권3호
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• pp.204-209
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• 2012

The purpose of this study was to construct database for a drug safety information website to serve as an access point of up-to-date resources for a wide variety of drug-safety information helping patients and healthcare professionals make well-informed decisions about medication use. All the contents developed were confirmed by the council of advisors who were the experts in drug safety. The detailed contents of database on frequently prescribed drug including 9 NSAIDs, 19 antibiotics, 24 cardiovascular, 21 metabolic, 14 respiratory, 20 digestive, 22 hormonal, 10 genitourinary, 10 anti-allergic, 27 antifungal/antiviral, and 71 neuropsychiatric agents were developed based on the approved drug labeling of the Korean FDA. A separately searchable database of drug-specific safety information for patients and health professionals was constructed for users in need of different depth of knowledge on using medications safely. The safety information on highly prevalent chronic diseases and drug classes was also developed. Finally the most recent global drug safety news was provided. The consumer directed information was developed in layman's terms as means of proving user-friendly information. The creation of this type of website is part of the Korean FDA's ongoing initiative to address and promote the safe use of medications for the public.

• 한국임상약학회지
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• 제31권1호
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• pp.21-26
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• 2021

Background: Pharmacogenomics is the study of how genetic mutations in patients affect their response to drugs. Pharmacogenomic studies aim to maximize drug effects and minimize adverse drug events. The Food and Drug Administration and the European Medicine Agency published guidelines for pharmacogenetics in 2005 and 2006, respectively; the Korean Ministry of Food and Drug Safety followed suit in 2015. Methods: This study analyzed pharmacogenomic information in the Korean Ministry of Food and Drug Safety's integrated drug information system to evaluate whether domestic pharmaceutical products reflect the current research on pharmacogenomic differences. Results: In June 2020, the Korean pharmacogenomic database contained genomic data on 90 compounds. Of these, 45 compounds were classified as "Antineoplastic and immunomodulating agents." The other 45 non-antineoplastic agents were in the following categories: Anti-infectives, Mental & behavior disorder, Hormone & metabolism related diseases, Cardiovascular system, Skin & subcutaneous tissue disease, Genito-urinary system and sex hormones, Blood and blood forming organs, Nervous system, Alimentary tract and metabolism, Musculo-skeletal system, and Other conditions including the respiratory system. In addition, 30 additives unrelated to the main ingredient were associated with genetic precautions. Conclusion: This study showed that antineoplastic and immunomodulating agents accounted for half the drugs associated with pharmacogenetic information. For antitumor and immunomodulatory drugs, genomic tests were recommended depending on the indication; this was in contrast to genomic testing recommendations for non-antineoplastic medications. Genomic tests were rarely requested or recommended for non-antineoplastic medications because the relationships between genotype and efficacy among those drugs were relatively weak.

• Journal of Nutrition and Health
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• 제43권2호
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• pp.181-188
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• 2010

본 연구에서는 가공식품 및 외식업체 메뉴의 영양표시 시행에 대한 소비자들의 인식도를 조사하였다. 본 조사는 전국 20세~59세의 부모 1,507명을 대상으로 하여 전화면담으로 이루어졌다. 전체응답자의 89.8%가 가공식품에 영양표시가 있다는 것을 알고 있었으며, 응답자중 72.3%가 식품 구입시 영양표시를 확인하는 것으로 나타났다. 우선적으로 확인하는 영양표시 항목은 지방 (57.1%), 열량 (56.3%), 나트륨 (49.0%)이었으며, 알기 쉽고 눈에 잘 띄도록 표시되기를 원하는 항목은 트랜스지방 (62.1%), 콜레스테롤 (26.9%), 열량 (23.9%), 나트륨 (21.0%)순이었다. 외식에 영양표시를 시행할 경우 90.6%의 응답자는 영양표시가 메뉴선택에 영향을 미칠 수 있다고 응답하였다. 패스트푸드 이외에 영양표시 시행을 원하는 외식업체는 '피자 및 치킨'이 60.7%로 가장 높았다. 외식영양표시 시행 시우선적으로 표시하기를 원하는 영양성분은 열량 (62.0%), 지방 (60.3%), 나트륨 (50.9%)으로 나타났다. 본 조사결과 소비자들은 외식 영양표시 실시에 대하여 매우 호의적이며, 표시영양성분 중 열량을 가장 중요시 하는 것으로 조사되었다. 따라서 소비자가 현명하게 식품을 선택할 수 있는 제도가 마련되어야 할 필요가 있는 것으로 사료된다.

• 한국임상약학회지
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• 제27권4호
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• pp.221-227
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• 2017

Background: As personalized healthcare industry has attracted much attention, big data analysis of healthcare data is essential. Lots of healthcare data such as product labeling, biomedical literature and social media data are unstructured, extracting meaningful information from the unstructured text data are becoming important. In particular, text mining for adverse drug reactions (ADRs) reports is able to provide signal information to predict and detect adverse drug reactions. There has been no study on text analysis of expert opinion on Korea Adverse Event Reporting System (KAERS) databases in Korea. Methods: Expert opinion text of KAERS database provided by Korea Institute of Drug Safety & Risk Management (KIDS-KD) are analyzed. To understand the whole text, word frequency analysis are performed, and to look for important keywords from the text TF-IDF weight analysis are performed. Also, related keywords with the important keywords are presented by calculating correlation coefficient. Results: Among total 90,522 reports, 120 insulin ADR report and 858 tramadol ADR report were analyzed. The ADRs such as dizziness, headache, vomiting, dyspepsia, and shock were ranked in order in the insulin data, while the ADR symptoms such as vomiting, 어지러움, dizziness, dyspepsia and constipation were ranked in order in the tramadol data as the most frequently used keywords. Conclusion: Using text mining of the expert opinion in KIDS-KD, frequently mentioned ADRs and medications are easily recovered. Text mining in ADRs research is able to play an important role in detecting signal information and prediction of ADRs.