• Korean Journal of Clinical Laboratory Science
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• v.55 no.4
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• pp.298-305
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• 2023

Burkitt's lymphoma is a distinct subtype of non-Hodgkin's lymphoma originating from B-cells that is notorious for its aggressive growth and association with immune system impairments, potentially resulting in rapid and fatal outcomes if not addressed promptly. Optimizing the use of Food and Drug Administration-approved medications, such as combining known safe drugs, can lead to time and cost savings. This method holds promise in accelerating the progress of novel treatments, ultimately facilitating swifter access for patients. This study explores the potential of a dual-targeted therapeutic strategy, combining the bruton tyrosine kinase-targeting drug Ibrutinib and the epidermal growth factor receptor/human epidermal growth factor receptor-2-targeting drug Lapatinib. Ramos and Daudi cell lines, well-established models of Burkitt's lymphoma, were used to examine the impact of this combination therapy. The combination of Ibrutinib and Lapatinib inhibited cell proliferation more than using each drug individually. A combination treatment induced apoptosis and caused cell cycle arrest at the S and G2/M phases. This approach is multifaceted in its benefits. It enhances the efficiency of the drug development timeline and maximizes the utility of currently available resources, ensuring a more streamlined and resource-effective research process.

• Journal of the Korea Society of Computer and Information
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• v.21 no.3
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• pp.65-71
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• 2016

To reduce the expenses for development a novel drug, systems biology has been studied actively. Target prediction, a part of systems biology, contributes to finding a new purpose for FDA(Food and Drug Administration) approved drugs and development novel drugs. In this paper, we propose a classification model for predicting novel target genes based on relation between target genes and disease related genes. After collecting known target genes from TTD(Therapeutic Target Database) and disease related genes from OMIM(Online Mendelian Inheritance in Man), we analyzed the effect of target genes on disease related genes based on PPI(Protein-Protein Interactions) network. We focused on the distinguishing characteristics between known target genes and random target genes, and used the characteristics as features for building a classifier. Because our model is constructed using information about only a disease and its known targets, the model can be applied to unusual diseases without similar drugs and diseases, while existing models for finding new drug-disease associations are based on drug-drug similarity and disease-disease similarity. We validated accuracy of the model using LOOCV of ten times and the AUCs were 0.74 on Alzheimer's disease and 0.71 on Breast cancer.

• Radiation Oncology Journal
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• v.36 no.4
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• pp.265-275
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• 2018

Cancer is a complex multifaceted illness that affects different patients in discrete ways. For a number of cancers the use of chemotherapy has become standard practice. Chemotherapy is a use of cytostatic drugs to cure cancer. Cytostatic agents not only affect cancer cells but also affect the growth of normal cells; leading to side effects. Because of this, radiotherapy gained importance in treating cancer. Slaughtering of cancerous cells by radiotherapy depends on the radiosensitivity of the tumor cells. Efforts to improve the therapeutic ratio have resulted in the development of compounds that increase the radiosensitivity of tumor cells or protect the normal cells from the effects of radiation. Amifostine is the only chemical radioprotector approved by the US Food and Drug Administration (FDA), but due to its side effect and toxicity, use of this compound was also failed. Hence the use of herbal radioprotectors bearing pharmacological properties is concentrated due to their low toxicity and efficacy. Notably, in silico methods can expedite drug discovery process, to lessen the compounds with unfavorable pharmacological properties at an early stage of drug development. Hence a detailed perspective of these properties, in accordance with their prediction and measurement, are pivotal for a successful identification of radioprotectors by drug discovery process.

• Journal of Pharmaceutical Investigation
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• v.30 no.4
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• pp.299-307
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• 2000

생물학적 동등성 시험은 동일 성분을 동량 함유한 제제가 유사조건에서 투여되었을 경우 그 유효성분이 전신순환혈이나 작용부위에서 유용하게 되는 속도 및 양에 큰 차이가 없음을 입증하는 시험이다. 즉 이미 제조허가 되어 시판중인 의약품과 동일한 품목의 제조허가를 받기 위한 경우이거나 생체이용률이 동일함을 증명하기 위해 실시하는 시험이다. 우리 나라에서는 1989년 1월 1일 이후 허가된 전문의약품으로서 신약과 동일한 의약품, 패취제제, 제제개선을 통해 흡수율을 높이는 경우에 생물학적 동등성 시험을 하도록 의무화하고 있다. 미국 FDA는 1975년 6월 생체이용률, 생물학적 동등성에 관한 규제안을 발표하였고, 우리 나라에서도 1988년 10월에 생물학적 동등성 시험 기준을 제정하였다. 유럽에서는 1991년 12월 CPMP(Committee for Proprietary Medicinal Products)에 의해 최초로 "생체이용률 및 생물학적 동등성에 대한 가이드라인"이 채택되었다. 그후 전문가 회의를 거쳐 규정 전반에 관한 것과 일반적 항목에 대한 검토가 이루어져 최종 개정된 가이드라인이 만들어졌다. 현재 in vivo 생체 이용률을 비교하는 생물학적 동등성 시험의 중요성이 증대되고 있고, 국제적으로도 각 국가별 생물학적 동등성 시험의 평가방법이나 기준설정에 대한 연구가 다양하게 이루어지고 있다. 또한 ICH에서도 생물학적 동등성 시험의 국제적 조화를 위한 시도가 이루어지고 있다. 우리 나라의 현행 생물학적 동등성 기준은 1998년 개정된 것을 사용하고 있으나 국제적 발전 추세에 맞추어 기준의 제고를 모색하고 있다. 그 일환으로 유럽의 "의약품의 생체이용률 및 생물학적 동등성 시험 가이드라인"을 소개하고자 한다., globunlin II의 두 component로 분리(分離)되었고 oryzenin은 시료(試料) 육우(陸羽) 132호(號), 등판(藤坂) 5호(號), 관산(關山) 재건(再建)에서는 oryzenin I, oryzenin II, oryzenin III의 3 component를 분리(分離)하였고 팔달(八達), 진흥(振興), 서광(瑞光), 은방주(銀坊主), 다마금(多摩錦), Pin Galw56의 6시료(試料)에서는 oryzenin II, oryzenin III의 2 component만 분리(分離)하였다. 3. 각(各) fraction을 여지전기영동(濾紙電氣泳動)하여 각(各) component의 농도곡선(濃度曲線)에 의해 함량(含量)을 구(求)한 결과(結果) albumin 0.26%, globulin I, 0.35%, globulin II, 0.32%, prolamin, 0.41%, oryzenin I, 0.30%, oryzenin II, 2.23%, oryzenin III, 2.66%이었다.미국의 경우 3일 이내 전화나 FAX로 보고하고, 10일이내 문서로써 보고하도록 되어 있다. 이러한 임상적 안전성 자료 관리에 대한 신속 보고 정의 및 기준에 대해서는 ICH에서도 논의가 되어 Step 4까지 다다르고 있으므로 앞으로 각 국에서의 적용만 남아있는 상태이고 보면 신약의 개발과 더불어 임상시험에서의 부작용등의 안전성 자료 관리에 대한 중요성은 더욱 강조될 것이다.공하는 음식의 섭취정도에도 영향을 주고 있으므로 학생들에게 학부모와 전담교사 및 학교영양사는 학생들에게 이상적인 아침식사에 대한 교육은 물론이고 아침식사를 실천할 수 있도록 다양한 방안에 대해 함께 연구해야 하겠다. 정부차원에서 학교급식에 아침식사 프로그램을 도입할

• Bulletin of the Korean Chemical Society
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• v.33 no.7
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• pp.2163-2167
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• 2012

A rapid, specific, and reliable LC-MS/MS-based bioanalytical method was developed and validated in rat plasma for the simultaneous quantitation of amitriptyline and its metabolite nortriptyline. Chromatographic separation of these analytes was achieved on a Gemini C18 column ($50{\times}4.60mm$, $5{\mu}m$) using reversed-phase chromatography. The mobile phase was an isocratic solvent system consisting of 1% formic acid in water and methanol (10:90, v/v), at a flow rate of 0.2 mL/min. The analytical range was set as 0.1-500 ng/mL for amitriptyline and 0.08-500 ng/mL for nortriptyline using a $200{\mu}L$ plasma sample. The accuracy and precision of the assay were in accordance with FDA regulations for the validation of bioanalytical methods. The validated method was successfully applied to a pharmacokinetic study in six rats after oral administration of amitriptyline (15 mg/kg). This method allows laboratory scientists to rapidly determine amitriptyline and nortriptyline concentrations in plasma.

• Microbiology and Biotechnology Letters
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• v.42 no.1
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• pp.1-10
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• 2014

Most microorganisms have been used for foods for such a long period of time with no question posed for their safety. However, the progress of food processing technology has activated international food trades, and the consumers and authorities of import countries have come to question the safety of microorganisms used in foods. At present, the most widely known safety standards are Generally Recognized as Safe (GRAS) status from the US Food and Drug Administration (FDA) and Qualified Presumption of Safety (QPS) status by the European Food Safety Authority (EFSA). GRAS status is not for the safety of microorganisms themselves but for the permissibility of strains or cultures in specific food uses. QPS provides a qualified generic approval to a defined taxonomic unit. The increase of commercialized traditional fermented foods in Korea has spurred the starter development for traditional food fermentations. However, starter development in Korea has been carried out based on the technological properties of microorganisms with no research on developing a standardized tool for safety assessment. In the globalization of traditional Korean fermented foods, technological properties as well as safety of future starters should be guaranteed, and establishment of the safety assessment regulation for microorganisms used for foods is necessary.

• Journal of Microbiology and Biotechnology
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• v.21 no.9
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• pp.954-959
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• 2011

There have been a number of studies conducted in order to compare the efficiencies of recovery rates, utilizing different protocols, for the isolation of L. monocytogenes. However, the severity of multiple cell injury has not been included in these studies. In the current study, L. monocytogenes ATCC 19112 was injured by exposure to extreme temperatures ($60^{\circ}C$ and $-20^{\circ}C$) for a one-step injury, and for a two-step injury the cells were transferred directly from a heat treatment to frozen state to induce a severe cell injury (up to 100% injury). The injured cells were then subjected to the US Food and Drug Administration (FDA), the ISO-11290, and the modified United States Department of Agriculture (mUSDA) protocols, and plated on TSAyeast (0.6% yeast), PALCAM agar, and CHROMAgar Listeria for 24 h or 48 h. The evaluation of the total recovery of injured cells was also calculated based on the costs involved in the preparation of media for each protocol. Results indicate that the mUSDA method is best able to aid the recovery of heat-injured, freeze-injured, and heat-freeze-injured cells and was shown to be the most cost effective for heat-freeze-injured cells.

• Bulletin of Food Technology
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• v.12 no.4
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• pp.36-44
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• 1999

기존의 미국 식품의약국(FDA, Food and Drug Administration)규정에 따르면 어떤 식품첨가물의 기능과 안정성을 평가하는 방법은 그때 그때 각각의 경우에 맞게 설정하여 실시하게 되어 있다. 이런 평가 방법은 포괄적이기는 하지만 과잉의 기능과 안정성 시험을 실시하는 결과를 초래해 왔다. 여기서는 새로운 식품 첨가물에 대한 안정성 시험 시 그 첨가물이 사용되는 실제 조건 하에서 체계적이고 과학적인 접근 방법에 따라 시험이 되도록 할 것을 제안하고자 한다. 체계적인 방법으로 시험하기 위해서는 새로 개발된 식품첨가물들이 사용하게 될 적용 대상 식품의 여러가지조건(pH, 수분, 가공 및 저장 온도)에서 그 첨가물의 안정성에 영향을 미치는 화학적, 물리적 주요 요인들이 먼저 결정되어야 한다. 그 다음 기능성과 안전성에 관련된 요소들이 하나의 모델 시스템으로 조직화되어 주요요인들의 측정 범위가 정해져야 한다. 마지막으로 설정된 모델 시스템은 첨가물이 실제 적용받게 되는 가공,운송, 저장 조건 하에서의 사용 조건을 고려한 상태에서 첨가물을 시험하여 기능과 안정성이 입증되어야 한다. 일단 증명이 되면 그 모델 시스템은 사용 가능성이 있는 적용 범위에까지도 그 첨가물의 기능성과 안정성을 평가할 수 있게 해준다. 이 논문에서는 식품첨가물 시험방법에 대한 체계적인 접근 방법을 설명하고 아스파탐의 예를 들어서 그 방법을 조명해 보고자 한다.

• Korean Journal of Clinical Pharmacy
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• v.22 no.1
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• pp.21-29
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• 2012

Modern biologics are biotechnology-derived therapeutics, including recombinant therapeutic proteins like monoclonal antibodies, cytokines and tissue growth factors. Although the pharmacokinetics of therapeutic biologics should be evaluated based on the same general principles as small molecules, careful considerations should be given to bioanalytics and pharmacokinetics when designing pharmacokinetic studies of biologics during their drug development, due to their different physicochemical properties compared with small molecules. The aim of this study was to develop a draft guidance on pharmacokinetic studies of therapeutic biologics in clinical studies. All the elements outlined in the current Food and Drug Administration (FDA), European Medicinal Agency (EMEA), and International Conference on Harmonisation (ICH) guidelines and regulations, and the related literatures previously published were searched and evaluated. In this draft guidance, the specific problems related to the pharmacokinetics of therapeutic biologics that need special consideration during drug development process were addressed, and differences in pharmacokinetic characteristics between biologics and small molecules affecting the content of the development programme were presented.

• Journal of Dental Anesthesia and Pain Medicine
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• v.23 no.5
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• pp.287-291
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• 2023

Sugammadex has shown faster reversal of steroidal neuromuscular blockade (NMB) than neostigmine, a traditional reversal agent for NMB, even in the intense block phase. This efficiency is possible because of the unique mechanism of action by encapsulating the NMB molecules. Therefore, with the use of sugammadex, we can also expect to avoid direct interactions with the cholinergic system and its subsequent side effects, which are disadvantages of traditional drugs. However, despite these benefits and US Food and Drug Administration (FDA) approval in 2015, rare adverse events associated with sugammadex have been reported. Herein, we report a case of bronchospasm that developed immediately after sugammadex administration.