• 한국환경보건학회지
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• 제50권2호
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• pp.125-137
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• 2024

Background: The Korea Risk Information Surveillance System (K-RISS) was developed to enable the early detection of food and drug safety-related issues. Its goal is to deliver real-time risk indicators generated from ongoing food and drug risk monitoring. However, the existing K-RISS system suffers under several limitations. Objectives: This study aims to augment K-RISS with more detailed indicators and establish a severity standard that takes into account structural changes in the daily time series of K-RISS values. Methods: First, a Delphi survey was conducted to derive the required weights. Second, a control chart, commonly used in statistical process controls, was utilized to detect outliers and establish caution, attention, and serious levels for K-RISS values. Furthermore, Bai and Perron's method was employed to determine structural changes in K-RISS time series. Results: The study incorporated 'closeness to life' and 'sustainability' indicators into K-RISS. It obtained the necessary weights through a survey of experts for integrating variables, combining indicators by data source, and aggregating sub K-RISS values. We defined caution, attention, and serious levels for both average and maximum values of daily K-RISS. Furthermore, when structural changes were detected, leading to significant variations in daily K-RISS values according to different periods, the study systematically verified these changes and derived respective severity levels for each period. Conclusions: This study enhances the existing K-RISS system and introduces more advanced indicators. K-RISS is now more comprehensively equipped to serve as a risk warning index. The study has paved the way for an objective determination of whether the food safety risk index surpasses predefined thresholds through the application of severity levels.

• 한국임상약학회지
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• 제34권1호
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• pp.39-61
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• 2024

Background: The Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the Ministry of Food and Drug Safety (MFDS) have been implementing the expedited programs that promote the innovative approval of new medications to be used for serious diseases. The authors comprehensively investigated, analyzed, and compared the regulations and guidelines associated with the expedited programs. Methods: The expedited programs for innovative drug development and approval were searched from the homepages of FDA, EMA and MFDS. The detailed information on the regulations and guidelines associated with the programs was comprehensively extracted from various electronic repositories of each regulatory authority. The information on each program was analyzed, categorized, and compared from the points of benefits, applicability with scientific rationale, application procedure, and maintenance. Results: FDA's programs include Fast Track Designation, Breakthrough Therapy Designation, Priority Review Designation, and Accelerated Approval. EMA's regulation implements PRIority MEdicines (PRIME), Accelerated Assessment, Marketing Authorization under Exceptional Circumstances (MAEC), and Conditional Marketing Authorization (CMA). MFDS has a single Expedited Program. These programs are broadly categorized into those that 1) facilitate early and proactive communication with regulatory authorities, 2) shorten the review time after submitting a marketing application, and 3) temporarily approve a marketing authorization under certain conditions. Conclusion: Each expedited program requires a different level and amount of safety and efficacy evidence to be submitted to each regulatory authority. This article will likely provide the comprehensive information on which program provides scientific and regulatory advantages to be taken for innovative medication development.

• Journal of Evidence-Based Herbal Medicine
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• 제1권1호
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• pp.29-34
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• 2008

Good Laboratory Practice(GLP) is becoming more and more important in the research and development of Oriental Pharmacy(OP) and its globalization. If a OP product is to be registered as Over-the-Counter(OTC) drug and enter international markets, the safety and efficacy studies conducted according to GLP requirements is necessary. The article introduces the content of GLP requirements and the recent development of GLP. The safety and efficacy assessment for OP or herbal medicines under GLP are also covered. This paper also briefly describes the areas that should be covered by GLP regulation and the areas that do not need to follow GLP requirements.

• 한국식품위생안전성학회지
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• 제34권3호
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• pp.219-226
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• 2019

이 연구는 식품 중 잔류농약에 대한 국내 모니터링 프로그램의 전반적인 현황을 이해하기 위해 수행되었으며 더 나아가 개선이 필요한 사항이 제안되었다. 이 연구로 부터 국내 잔류농약 모니터링 프로그램 현황은 다음과 같이 요약될 수 있었다. 국내에서는 식품의약품안전처가 잔류농약 모니터링을 총괄한다. 그리고 모니터링 시점(유통 또는 생산단계에서 시료수집)에 따라 모니터링 책임 기관이 다른데, 유통단계의 식품에 대해서는 식품의약품안전처, 지방식품의약품안전청, 지방자치단체가, 생산단계에서는 국립농산물품질관리원(NAQS)과 지방자치단체가 모니터링을 실시한다(부분적으로 판매와 유통단계에서도 실시). 국내의 모니터링 프로그램을 목적에 따라 구분하면 위해평가 모니터링(monitoring for risk assessment)으로 MFDS의 "잔류실태조사"와 NAQS의 "국가잔류조사"가 있고, 지방식품의약품안전청과 지방자치단체에서는 주로 규제 모니터링(monitoring for regulation)을 실시하고 있었다. 수입식품의 경우 통관단계(지방식품의약품안전청 책임)와 유통단계 모두에서 모니터링이 실시되어야 한다. 유통단계 수입식품 모니터링은 MFDS, 지방식품의약품안전청, 지방자치단체가 담당하고 있는 데 아직 체계적이고 지속적인 국가수준의 모니터링 프로그램이 실시되고 있지 않는 것으로 보인다. 국내 잔류농약 모니터링 프로그램과 관련하여 앞에서 기술한 내용과 더 상세한 내용을 토대로 모니터링 프로그램의 개선을 위해 i) 모니터링 프로그램의 목적에 대한 명확성 제고, ii) 수입식품에 대한 모니터링 프로그램의 강화 iii) 일반국민에게 모니터링 결과의 공개(연간보고서와 데이터베이스 발간)를 제안하였다. 식품의 안전성을 확보고 시행하기 시작한 농약 허용물질목록 관리제도(positive list system, PLS)가 성공을 거두기 위해서는 잔류농약 모니터링 프로그램에 대한 철저한 검토와 개선을 위한 노력이 필요한 것으로 생각된다.

• Toxicological Research
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• 제29권3호
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• pp.217-219
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• 2013

Hypertension is a serious health problem due to high frequency and concomitant other diseases including cardiovascular and renal dysfunction. Olmesartan cilexetil is a new antihypertensive drug associated with angiotensin II receptor antagonist. This study was conducted to evaluate the mutagenicity of olmesartan cilexetil by bacterial reverse mutation test using Salmonella typhimurium (TA100, TA1535, TA98, and TA1537) and Escherichia coli (WP2 uvrA). At the concentrations of 0, 62, 185, 556, 1667, and 5000 ${\mu}g$/plate, olmesartan cilexetil was negative in both Salmonella typhimurium and Escherichia coli regardless of presence or absence of metabolic activation system (S9 mix). These results demonstrate that olmesartan cilexetil does not induce bacterial reverse mutation.

• 약학회지
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• 제46권3호
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• pp.179-184
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• 2002

The abuse of dextromethorphan has been prevalent for 15 years in Korea and its fatal cases were reported even though it has proved to be very safe. In this study, to investigate the safety and tolerance assessment of dextromethorphan, the metabolic phenotyping and genotype of dextromethorphan were studied. After a single 30 mg of dextromethorphan oral administration to 74 volunteers, concentration of dextromethorphan and its metabolites, dextrorphan, hydroxymorphinan and methoxymorphinan were measured in urine which collected during 8hrs after the drug administration. CYP2D6 phenotype was determined from the ratio of dextromethorphan to dextrorphan. GC/MS was used to quantify dextromethorphan and its metabolites. For genotyping, mutant alleles of the CYP2D6 gene were identified. 24 subjects (32.4％) were homozygous for CYP2D6＊10B, 29 subjects (39.2％) were heterozygous for this allele, while in 21 subjects (28.4％) no exon 1 mutation could be found. The frequency of CYP2D6＊10B-allele containing the 188C T mutation was 54％ of total subjects studied.

• 한국식품위생안전성학회지
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• 제23권1호
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• pp.80-84
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• 2008

유해물질의 식품기준은 위해성이 인정될 때 정하는 것을 원칙으로 한다. 위해평가의 절차에 거쳐 정량적 수치로 인정되는 위해성은 정부의 관리방향을 설정하는데 중요한 정보를 제공한다. 대표성 있는 모니터링자료가 확보되어야 정확한 위해평가를 수행할 수 있으므로 만성적 건강영향을 나타내는 유해물질의 경우 장기적 모니터링결과를 확보하는 것이 필요하다. 과거에는 대다수 인구집단의 안전에 초점을 두었으나, 최근에는 고섭취에 의한 유해물질 고노출그룹, 동일노출 수준에서도 유해영향을 크게 나타내는 민감그룹, 노약자, 임산부 등의 안전까지도 검토 후 소수그룹까지 안전할 수 있는 기준을 설정하는 추세이다. 유해물질 기준검토를 위하여 최신의 독성정보, 통계정보, 분석기술정보, 낮출 수 있는 한 낮출 수 있는 ALARA(as low as reasonably achievable)정보들이 필요하다.

• 한국축산식품학회지
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• 제31권6호
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• pp.960-965
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• 2011

훈제식육식품을 통한 polycyclic aromatic hydrocarbons(PAHs)의 대표독성물질인 benzo[a]pyrene의 위해도를 판단하기위해 시중에 유통되는 69개의 훈제식육식품을 통한 위해성을 평가하였다. 사용된 훈제식육식품은 훈제 치킨, 오리, 칠면조, 돼지 등이며 benzo[a]pyrene의 검출범위는 불검출-2.87 ${\mu}g$/kg이었고 평균 농도는 0.42 ${\mu}g$/kg로 나타났다. 2005 국민건강영양조사를 참고하여 만성1일인체노출량을 평가한 결과 훈제식육식품을 통한 노출량은 총 0.187 ng/kg B.W./d로 나타났다. 위해도 산출을 위하여 benzo[a]pyrene의 위상부암에 대한 BMDL값인 0.31-0.74 mg/kg B.W./d와 만성1일인체노출량을 이용하여 MOE를 구한결과 MOE는 1,657,754-3,957,219 수준으로 나타났다. Benzo[a]pyrene의 오염도는 식품의약품안전청에서 제시하는 기준규격인 5 ${\mu}g$/kg 이하로 나타나 훈제식육식품을 통한 benzo[a]pyrene의 노출정도는 안전한것으로 판단된다.

• 한국응용약물학회:학술대회논문집
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• 한국응용약물학회 1995년도 제3회 추계심포지움
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• pp.135-136
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• 1995

Resent advances in computer technology have introduced a sophisticated capability for computing the biological fate of toxicants in a biological system. This methodology, which has drastically altered risk assessment skill in toxicology, is designed using all the mechanistic information, and all claim better accuracy with extrapolating capability Iron animal to people than conventional pharmacokinetic methods. Biologically based mathematical models in which the specific mechanistic steps governing tissue disposition(pharmacokinetics) and toxic action (pharmacodynamics) of chemicals are constructed in quantitative terms by a set of equations loading to prediction of the outcome of specific toxicological experiments by computer simulation. pharmacokinetic and pharmacodynamic models are useful in risk assessment because their mechanistic biological basis permits the high-to-low dose, route to route and interspecies extrapolation of the tissue disposition and toxic action of chemicals.

• Journal of Veterinary Science
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• 제25권1호
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• pp.18.1-18.27
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• 2024

Mastitis is one of the most widespread infectious diseases that adversely affects the profitability of the dairy industry worldwide. Accurate diagnosis and identification of pathogens early to cull infected animals and minimize the spread of infection in herds is critical for improving treatment effects and dairy farm welfare. The major pathogens causing mastitis and pathogenesis are assessed first. The most recent and advanced strategies for detecting mastitis, including genomics and proteomics approaches, are then evaluated. Finally, the advantages and disadvantages of each technique, potential research directions, and future perspectives are reported. This review provides a theoretical basis to help veterinarians select the most sensitive, specific, and cost-effective approach for detecting bovine mastitis early.