ABSTRACT
Background@#The need for regulatory science development to evaluate advanced regulatory products is gradually increasing without hindering the technological development. Creating a research environment and fostering experts through the establishment of regulatory agency-led policies are essential for the development of regulatory science. Method: This is a comparative study of the United States, Japan, Singapore, and Korea. The literature and websites of each regulatory agency were reviewed, and the focus was on advantages and comparing advantages based on definition, development trends, and expert training projects. @*Results@#The United States is striving to develop regulatory science in response to changes in the new pharmaceutical industry through the regulatory science report, and to foster expert both inside and outside the Food and Drug Administration (FDA). Japan is promoting regulatory science centered on regulatory science centers, and is focusing on researching work-related regulatory science within the Pharmaceuticals and Medical Devices Agency (PMDA) and improving employees’ ability to make regulatory decisions. Singapore was aiming to improve Southeast Asia’s regulatory capabilities under the leadership of Centre of Regulatory Excellence (CoRE) within Duke-NUS University. In 2021, Korea is in its early stages, starting to run a university's degree program related to regulatory science this year. @*Conclusion@#Regulatory science should be developed with the aim of improving the regulatory ability of the Ministry of Food and Drug Safety with Korea’s independent concept of regulatory science.
ABSTRACT
Background@#Need for regulatory science is emerging with the development of pharmaceutical industry. It is essential to train regulatory science experts to meet the needs of technology and regulations to evaluate advanced products. Major regulatory science countries are conducting the regulatory science activities and fostering the experts. @*Methods@#Published literature and the relevant website of European Union (EU) were reviewed and criteria were developed. In particular, we focused on in depth descriptions of the Innovative Medicines Initiative program, which was conducted twice. @*Results@#EU is striving to provide funding and training experts for the development of the regulatory science by horizon 2020 and regulatory science to 2025. Innovative medicines initiative (IMI) is a public-private partnership aimed at the development of the pharmaceutical industry, including the regulatory science. IMI education and training projects have provided various education and training course including short-term curriculum and master and doctoral course. The difference between South Korea’s regulatory science expert training project in 2021 and the EU’s IMI education and training projects is participation of pharmaceutical companies. While the pharmaceutical companies participate in the IMI project to select project topics and form a community, South Korea’s project is focused on the Ministry of Food and Drug Safety and universities. @*Conclusion@#Through successful active networks with regulatory party, pharmaceutical companies, and universities, a great innovative advance of regulatory science in South Korea is expected.
ABSTRACT
Background@#Need for regulatory science is emerging with the development of pharmaceutical industry. It is essential to train regulatory science experts to meet the needs of technology and regulations to evaluate advanced products. Major regulatory science countries are conducting the regulatory science activities and fostering the experts. @*Methods@#Published literature and the relevant website of European Union (EU) were reviewed and criteria were developed. In particular, we focused on in depth descriptions of the Innovative Medicines Initiative program, which was conducted twice. @*Results@#EU is striving to provide funding and training experts for the development of the regulatory science by horizon 2020 and regulatory science to 2025. Innovative medicines initiative (IMI) is a public-private partnership aimed at the development of the pharmaceutical industry, including the regulatory science. IMI education and training projects have provided various education and training course including short-term curriculum and master and doctoral course. The difference between South Korea’s regulatory science expert training project in 2021 and the EU’s IMI education and training projects is participation of pharmaceutical companies. While the pharmaceutical companies participate in the IMI project to select project topics and form a community, South Korea’s project is focused on the Ministry of Food and Drug Safety and universities. @*Conclusion@#Through successful active networks with regulatory party, pharmaceutical companies, and universities, a great innovative advance of regulatory science in South Korea is expected.
ABSTRACT
Human gut microbial community is playing a critical role in human health and associated with different human disease. In parallel, probiotics, antibiotics, and antipyretic analgesics (AAs) were developed to improve human health or cure human diseases. We therefore examined how probiotics, antibiotics, and AAs influence to the gut microbiota. Three independent case/control studies were designed from the cross-sectional cohort data of 1,463 healthy Koreans. The composition of the gut microbiota in each case and control group was determined via 16S ribosomal RNA Illumina next-generation sequencing. The correlation between microbial taxa and the consumption of each drug was tested using zero-inflated Gaussian mixture models, with covariate adjustment of age, sex, and body mass index (BMI). Probiotics, antibiotics, and AAs consumption yielded the significant differences in the gut microbiota, represented the lower abundance of Megasphaera in probiotics, the higher abundance of Fusobacteria in antibiotics, and the higher abundance of Butyrivibrio and Verrucomicrobia in AAs, compared to each control group. The reduction of Erysipelotrichaceae family was common in three drugs consumption.
Subject(s)
Humans , Analgesics , Anti-Bacterial Agents , Body Mass Index , Butyrivibrio , Cohort Studies , Fusobacteria , Gastrointestinal Microbiome , Megasphaera , Probiotics , RNA, Ribosomal, 16S , VerrucomicrobiaABSTRACT
BACKGROUND: It has been suggested that bilirubin has an inverse association with cardiovascular disease (CVD) due to its antioxidant properties. However, there are few data regarding the relationship between serum total bilirubin (sTB) and risk factors for CVD in Koreans. This study aimed to evaluate the relationship between sTB and high sensitivity C-reactive protein (hsCRP), which is an independent risk factor for CVD. METHODS: We performed a cross sectional study in 6,800 men who were examined at a health promotion center at a university hospital in Korea between May 2005 and June 2006. We grouped the subjects according to values of serum hsCRP (above or below 1.0 mg/L) and compared the characteristics of the two groups. To evaluate the relationship between sTB and hsCRP, we classified the subjects according to quartile values of sTB. Multivariate logistic regression analyses were used to analyze the relationship of levels of sTB and hsCRP after adjusting for known risk factors for CVD. RESULTS: Serum hsCRP was significantly associated with body mass index (BMI), smoking, diabetes, hypertension, fasting plasma glucose, systolic blood pressure, alanine aminotransferase, and total cholesterol/high density lipoprotein (TC/HDL-C) ratio, but not with age or alcohol use. As levels of sTB increased, there was a decrease in age, numbers of smokers, BMI, and TC/HDL ratio. Compared to the lowest quartile of sTB, levels of hsCRP decreased with odds ratios of 0.82 (95% CI, 0.71 to 0.96), 0.75 (95% CI, 0.65 to 0.88), and 0.63 (95% CI, 0.54 to 0.74) in the 2nd, 3rd, and 4th quartiles of bilirubin, respectively. CONCLUSION: Bilirubin may be inversely associated with hsCRP