• 한국응용약물학회:학술대회논문집
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• 한국응용약물학회 2002년도 창립10주년기념 및 국립독성연구원 의약품동등성평가부서 신설기념 국재학술대회:생물학적 동등성과 의약품 개발 전략을 위한 국제심포지움
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• pp.97-102
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• 2002

Life Science Research Center of SK Chemicals has developed a 3rd-generation anticancer platinum drug for the first time in the nation′s 100-year-old pharmaceutical industry. The Korea Food and Drug Administration (KFDA) approved the sale of "Sunpla" (code name SKI 2053R, general name : Heptaplatin) on July 14, 1999 for the treatment of advance, metastatic gastric cancer. Cisplatin, the 1 st-generation anticancer drug, which was developed by Bristol-Myers of the United States in 1976, is one of the most potent anticancer drugs and is a major component of combination chemotherapy for a variety of human cancers. However its clinical usefulness has frequently been limited not only by undesirable side effects such as severe renal toxicity, nausea, vomiting, ototoxicity, and neurotoxicity but also by the development of resistance. Carboplatin, the 2nd-generation anticancer platinum drug, which was also developed by Bristol-Myers in 1986, has modified the problems of the renal and gastrointestinal toxicities of cisplatin. Carboplatin, however, has no enhanced therapeutic efficacy over cisplatin and does not possess the property to overcome cross-resistance to cisplatin.

• 한국식품영양과학회지
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• 제26권5호
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• pp.983-992
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• 1997

During pregnancy and lactation, folate status is important because folate requirements increase during the periods as well as maternal folate status influences on pregnancy outcome and human milk folate; especially folate deficiency around periconceptional period may induce neural tube defects(NTDs) of fetus. There have been a plenty of evidences that maternal folate status deteriorates during pregnancy of fetus. There have been a plenty of evidences that maternal folate status deteriorates during pregnancy and lactation if folate needed is not sufficiently provided. The Public health Service of the United States recommends all child-bearing is not sufficiently provided. The Public Health Service of the United States recommends all child-bearing women to intake 0.4mg of folate daily, and the Food and Drug Administration the folate status of child-bearing women and to reduce the rate of occurrence of NTDs. Many authors have insisted that the current recommended dietary allowances of folate for Americans are too low to maintain good folate status. There are little data about Korean folate status including pregant and lactating women. A couple of reports indicated that the folate intakes of Korean pregant and lactating women are below the Korean RDAs of folate and serum folate levels of them are subnormal. The authors pregnant and lactating women. Therefore, it is worth to review the assessment methods of folate status of pregnant and lactating women, folate RDAs for them, the relationships between maternal folate status and pregnancy outcome as well as human milk folate, the methods to increase folate intake, and the problems of large dose of folic acid supplementatiion.

• 보건행정학회지
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• 제34권2호
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• pp.106-119
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• 2024

의약품 부족은 전 세계적으로 보건학적 위험을 초래할 수 있는 문제이다. 본 연구의 목적은 미국, 캐나다, 일부 유럽 국가에서 국가의 의약품 부족에 대응하는 정책을 비교하고, 시사점을 도출하고자 하였다. 본 연구는 'drug shortage'와 'stock-out'와 같은 키워드를 사용하여 검색엔진과 구글학술검색을 통해 검색된 보고서 및 논문들을 검토하였다. 미국은 의약품 제조 중단에 대한 보고시스템을 구축하고, 의약품 공급망 관리의 중요성을 강조하고 있다. 또한 의약품 부족에 대한 대응체계를 마련하고자, 정부부처와 민간기관 간 의약품 부족 테스크포스를 설립했다. 캐나다는 중앙 및 지방 정부, 민간 부문의 대표를 참여시켜 의약품 부족에 관한 이해관계자 운영위원회를 설립하고, 의약품 부족 문제에 대해 단계적 접근방식을 채택하고 있다. 유럽의약품청(European Medicines Agency)은 2019년 유럽 경제 지역(European Economic Area)의 의약품 부족 커뮤니케이션에 대한 지침을 발표하였다. 외국에서는 의약품 부족을 모니터링하고 적시에 대응하기 위해 다양한 이해관계자 간의 의사소통에 중점을 두고 있다는 점을 확인하였다. 국내에서도 의약품 수급불안정 문제가 지속되는 만큼, 전담조직을 구성하고 가이드라인을 마련하며, 정부, 제약사, 의약품 유통사 등 민간부문의 협의와 조정을 통해 문제를 개선하는 것이 필요하다.

• 한국응용과학기술학회지
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• 제25권4호
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• pp.539-555
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• 2008

It is well understood that developing new drugs is one of the highest value-added businesses in a country; however, the current governments' spending in pharmaceutical research and development(R&D) is minimal in Korea. This paper suggests that different governmental bodies should take in charge of different stages of the R&D process in order to maximize the use of limited government research funding. First, during the initial phase of the drug development, including clinical trials, the Ministry of Education, Science and Technology is the most appropriate governmental organization to support the research. For later procedures such as supporting the industries for exporting developed drugs, legislative approvals, and building infrastructure for future clinical trials should be supported by the Ministry of Knowledge and Economy and the Ministry of Health and Welfare along with the Korea Food and Drug Administration(KFDA). The KFDA, which is the main governmental agency approving newly developed drugs in the market, will need to take a crucial responsibility in the initial phase of the pharmaceutical R&D by guiding the industries with timely and proper information. As a first step, it is recommended to set up and operate a center for supporting new drugs, so that the industries can facilitate the development of marketable drugs which meet customers' needs. Later, in order to expedite the process of exporting and getting approvals of the newly developed drugs from foreign countries, it is necessary to develop new approval system, which includes introduction of the Good Manufacturing Practice (GMP), mandatory validation system, and education program for supporting expertise. Lastly, the KFDA needs to take an active role in developing Korean pharmaceutical industries by communicating with other foreign governments with regards to the globalization of the Korean pharmaceutical industries. For example, as a follow up after the Free Trade Agreement(FTA), active discussion on GLP of Mutual Recognition Agreement(MRA) with the United States of America, should be seriously considered.

• 한국식품과학회지
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• 제35권4호
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• pp.748-751
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• 2003

2002년 4월 스웨덴의 국립식품청인 SNFA(Swedish National Food Administration)에서 발암의심 물질인 아크릴아마이드가 식품에서 검출되었다고 보고하였다. 그 후 영국, 노르웨이, 스위스, 독일, 미국, 일본, 캐나다 등에서 가열 처리된 식품 중 아크릴아마이드 생성을 확인하였다. 이에 본 연구에서는 미국 FDA에서 추천하는 Liquid chromatography-tandem mass spectrometry(LC-MS/MS) 방법을 이용하여 국내 식품의 아크릴아마이드 검출양을 모니터링하였다. 모니터링 결과, 원료식품인 생감자와, 쌀을 원료로 하여 가열한 밥에서는 아크릴아마이드가 검출되지 않았으며, 도넛은 <30, 36 ppb 검출되었다. 건빵은 854, 1081 ppb 식빵에서는 <30 ppb, 시리얼은 $51{\sim}283\;ppb$ 검출되었다. 감자칩과 감자스낵은 $598{\sim}1709\;ppb$, 비스킷은 $115{\sim}241\;ppb$, 후렌치 후라이는 $341{\sim}1896\;ppb$ 검출되었다. 커피는 $160{\sim}220\;ppb$, 초코릿은 $47{\sim}63\;ppb$ 검출되었다.

• BMB Reports
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• 제57권1호
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• pp.50-59
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• 2024

The application of gene engineering in livestock is necessary for various reasons, such as increasing productivity and producing disease resistance and biomedicine models. Overall, gene engineering provides benefits to the agricultural and research aspects, and humans. In particular, productivity can be increased by producing livestock with enhanced growth and improved feed conversion efficiency. In addition, the application of the disease resistance models prevents the spread of infectious diseases, which reduces the need for treatment, such as the use of antibiotics; consequently, it promotes the overall health of the herd and reduces unexpected economic losses. The application of biomedicine could be a valuable tool for understanding specific livestock diseases and improving human welfare through the development and testing of new vaccines, research on human physiology, such as human metabolism or immune response, and research and development of xenotransplantation models. Gene engineering technology has been evolving, from random, time-consuming, and laborious methods to specific, time-saving, convenient, and stable methods. This paper reviews the overall trend of genetic engineering technologies development and their application for efficient production of genetically engineered livestock, and provides examples of technologies approved by the United States (US) Food and Drug Administration (FDA) for application in humans.

• 약학회지
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• 제44권4호
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• pp.308-314
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• 2000

Logarithmic transformation of pharmacokinetic parameters is routinely used in bioequivalence studies based on pharmacokinetic and statistical grounds by the United States Food and Drug Administration (FDA), European Committee for Proprietary Medicinal Products (CPMP), and Japanese National Institute of Health and Science (NIHS). Although it has not yet been recommended by the Korea Food and Drug Administration (KFDA), its use is becoming increasingly necessary in order to harmonize with international standards. In the present study, statistical procedures for the analysis of a bioequivalence based on the log transformation and a related SAS procedure were demonstrated in order to aid the understanding and application. The AUC parameters used in this demonstration were taken from the previous bioequivalence study for two aceclofenac tablets, which were performed in a single-dose crossover design. Analysis of variance (ANOVA), statistical power to detect 20% difference between the tablets, minimum detectable difference and confidence intervals were all assessed following log-transformation of the data. Bioequivalence of two aceclofenac tablets was then estimated based on the guideline of FDA. Considering the international effort for harmaonization of guidelines for bioequivalence tests, this approach may require a further evaluation for a future adaptation in the Korea Guidelines of Bioequivalence Tests (KGBT).

• The Korean Journal of Physiology and Pharmacology
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• 제26권6호
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• pp.439-446
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• 2022

The antitumoral effects of valdecoxib (Val), an United States Food and Drug Administration-approved anti-inflammatory drug that was withdrawn due to the side effects of increased risk of cardiovascular adverse events, were investigated in hypopharyngeal squamous cell carcinoma cells by performing a cell viability assay, transwell assay, immunofluorescence imaging, and Western blotting. Val markedly inhibited cell viability with an IC50 of 67.3 µM after 48 h of treatment, and also downregulated cell cycle proteins such as Cdks and their regulatory cyclin units. Cell migration and invasion were severely suppressed by inhibiting integrin α4/FAK expression. In addition, Val activated the cell cycle checkpoint CHK2 in response to excessive DNA damage, which led to the activation of caspase-3/9 and induced caspase-dependent apoptosis. Furthermore, the signaling cascades of the PI3K/AKT/mTOR and mitogen-activated protein kinase pathways were significantly inhibited by Val treatment. Taken together, our results indicate that Val can be used for the treatment of hypopharyngeal squamous cell carcinoma.

• Biomolecules & Therapeutics
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• 제28권1호
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• pp.18-24
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• 2020

Notable progress has been made in the therapeutic and research applications of cyclic peptides since our previous review. New drugs based on cyclic peptides are entering the market, such as plecanatide, a cyclic peptide approved by the United States Food and Drug Administration in 2017 for the treatment of chronic idiopathic constipation. In this review, we discuss recent developments in stapled peptides, prepared with the use of chemical linkers, and bicyclic/tricyclic peptides with more than two rings. These have widespread applications for clinical and research purposes: imaging, diagnostics, improvement of oral absorption, enzyme inhibition, development of receptor agonist/antagonist, and the modulation of protein-protein interaction or protein-RNA interaction. Many cyclic peptides are expected to emerge as therapeutics and biochemical tools.

• Journal of Yeungnam Medical Science
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• 제38권3호
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• pp.175-182
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• 2021

Breast implant-associated anaplastic large-cell lymphoma (BIA-ALCL) is a rare T-cell non-Hodgkin lymphoma characterized as CD30 positive and anaplastic lymphoma kinase (ALK) negative. In 2016, the World Health Organization declared BIA-ALCL as a new disease entity. The first case of BIA-ALCL was reported in 1997, and as of July 2019, the United States Food and Drug Administration had cited a total of 573 United States and global medical device reports of BIA-ALCL, including 33 deaths. In all clinical case reports, except for those with unknown clinical history, the patient had received at least one textured surface breast implant. Although the etiology is not yet clear, chronic inflammation has been proposed as a potential precursor to tumorigenesis. The most common presentation of BIA-ALCL is peri-implant fluid collection following aesthetic or reconstructive implantation with textured surface breast implants. It can be accompanied by breast swelling, asymmetry, pain, skin lesions, lymphadenopathy, and B-type symptoms. Most cases are detected on average 7 to 10 years after implantation. Diagnostic specimens can be obtained with fine-needle aspiration or biopsy. BIA-ALCL is CD30 positive, epithelial membrane antigen positive, and ALK negative. It can be cured with complete surgical excision at the T1-T3 stage.