• Korean Journal of Clinical Pharmacy
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• v.16 no.2
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• pp.123-130
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• 2006

The study was aimed to recommend the ways for improving regulatory system of quasi-drugs in governmental authority by comparing with other countries. According to the regulations, the scope of quasi-drugs includes 3 categories of 1) the health aids made of textile, rubber and paper, 2) the health aids which have very minimal effects or no any effects on humans, and 3) disinfectants and pesticides. In US, these quasi-drugs in Korea are classified into 5 categories of medical device, cosmetics, OTC drugs, dietary supplements and pesticides. To improve quasi-drugs administration in Korea, it is concluded that several measures should be implemented : 1) establish clear criteria for classifying into quasi-drugs and more detailed guidelines on designation of quasi-drugs, 2) reform current regulations to meet 3-categories characteristics, supplement detailed guidelines on quasi-drugs administration for effective application process, and update relevant regulations for efficacy, safety and quality, 3) update quasi-drug monographs, 4) re-evaluate current classification of individual quasi-drugs, 5) develop comprehensive list by ingredients, 6) reform post-marketing management system for safety and quality, 7) strengthen the review agency function by increasing the number of experts, 8) develop the database for quasi-drugs for effective information management.

• Proceedings of the Korean Society of Applied Pharmacology
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• 2007.11a
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• pp.19-27
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• 2007

An important potential of metabolomics-based approach is the possibility to develop fingerprints of diseases or cellular responses to classes of compounds with known common biological effect. Such fingerprints have the potential to allow classification of disease states or compounds, to provide mechanistic information on cellular perturbations and pathways and to identify biomarkers specific for disease severity and drug efficacy. Metabolic profiles of biological fluids contain a vast array of endogenous metabolites. Changes in those profiles resulting from perturbations of the system can be observed using analytical techniques, such as NMR and MS. $^1H$ NMR was used to generate a molecular fingerprint of serum or urinary sample, and then pattern recognition technique was applied to identity molecular signatures associated with the specific diseases or drug efficiency. Several metabolites that differentiate disease samples from the control were thoroughly characterized by NMR spectroscopy. We investigated the metabolic changes in human normal and clinical samples using $^1H$ NMR. Spectral data were applied to targeted profiling and spectral binning method, and then multivariate statistical data analysis (MVDA) was used to examine in detail the modulation of small molecule candidate biomarkers. We show that targeted profiling produces robust models, generates accurate metabolite concentration data, and provides data that can be used to help understand metabolic differences between healthy and disease population. Such metabolic signatures could provide diagnostic markers for a disease state or biomarkers for drug response phenotypes.

• Journal of Society of Preventive Korean Medicine
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• v.22 no.3
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• pp.11-19
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• 2018

Objectives : The aim of this study is to investigate the current research trend of herbal medicine based on the published articles in pharmacoepidemiologic journals. Methods : A total of 3 electronic journals, Pharmacoepidemiology and Drug Safety(PDS), Drug Safety and Journal of Pharmacoepidemiology and Risk Management(JPERM) from January 2013 to August 2018 were used for searching articles about herbal medicine. Selected articles were reviewed and classified under 5 categories-collection of adverse events in herbal medicine, statistical modeling and methodology, pharmaco-epidemiologic outcome study, drug utilization review(DUR), risk management system and regulation. Results : A total of 8 articles were finally included for analysis. 2 articles were categorized in collection of adverse events in herbal medicine, 1 was statistical modeling and methodology, 2 were pharmacoepidemiologic outcome study and 3 were risk management system and regulation. There was no article in DUR. And then pharmacoepidemiologic research trends of herbal medicine were summarized in classification of 5 categories. Conclusions : To sum up with these 8 articles of herbal medicine in pharmacoepidemiologic journals, herbal medicine was of interesting concern among researchers. The need for research on safety and risk management of herbal medicine is steadily increasing, pharmacoepidemiologic research about herbal medicine must be activated in Korea.

• The Korea Journal of Herbology
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• v.27 no.6
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• pp.15-21
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• 2012

Objective : Lonicera japonica THUNB. a traditional herbal medicine, has been commonly used anti-inflammatory disease. It has been very complicated with respect to its sources on the market. The significant selection of medicine depends on its origin. However, it is difficult to discrimination criteria for confirming L. japonica authenticity using the senses. This study was performed to determine the discriminant analysis of L. japonica and L. confusa. Methods : The identification of L. japonica and L. confusa were performed by the classification and identification committee of the national center for standardization of herbal medicines. And we examined its differences using HPLC and genetic marker analysis. Results : The analytical pattern of High Performance Liquid Chromatography was determined from the corresponding peak curves ((E)-aldosecologanin, chlorogenic acid, luteolin 7-O-glucoside, sweroside). For L. japonica, additional unknown peaks were detected at 13.8 min, 20.6 min, and 36.9 min. And, we developed genetic marker using the the tRNA-Leu gene, trnL-trnF intergenic spacer and tRNA-Phe region of chloroplast DNA. By the method, 164 bp PCR product amplified from L. confusa was distinguished into L. japonica and L. confusa efficiently. Conclusion : Base on these results, two techniques provide effective approaches to distinguish L. japonica from L. confusa.

• Journal of Pharmaceutical Investigation
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• v.34 no.3
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• pp.229-254
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• 2004

The objective of this study was to scrutinize the rationale of SUPAC-MR and its application in processing postapproval changes to modified release solid oral dosage forms. The types of postapproval changes that were primarily covered with SUPAC-MR included variations in the components and composition, the site of manufacturing, batch size, manufacturing equipment, and manufacturing process. SUPAC-MR defined levels of postapproval changes that the industry might make. Classification of such categories was based on the likelihood of risk occurrence and potential impact of changes upon the safety and efficacy of approved drug products. In most cases, the changes could be classified into 3 levels. It described what chemistry, manufacturing, and control tests should be conducted for each change level. The important tests specified in SUPAC-MR were batch release, stability, in vitro dissolution, and in vivo bioequivalence tests. It then suggested what type of a filing report should be submitted to the FDA for each change level. In general, level 1 changes could be reported in an annual report, whereas level 2 and/or 3 changes could be submitted in changes-being-effected or prior approval supplements. It could be understood that the purpose of SUPAC-MR was to maintain the safety and quality of approved modified release solid oral dosage forms undergoing certain changes. At the same time, it contributed to providing a less burdensome regulatory process with the manufacturers when they wanted to make postapproval changes. European regulatory agencies also implemented SUPAC-like regulations in handling such changes to drug products. Therefore, in this study a recommendation was made for KFDA and the Korean industry to evaluate thoroughly the usefulness of these guidances and regulations in dealing with postapproval changes to modified release solid oral dosage forms.

• Korean Journal of Veterinary Service
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• v.15 no.2
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• pp.134-143
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• 1992

The present study was conducted to investigate the biochemical characteristics and anti-biotic resistance of Escherichia coli(E. coli) isolated from piglets with diarrhea in Kyongbuk province during the Period from February to November 1991. 368 E. coli strains were isolated from 382 piglets with diarrhea and the biochemical and cultural reaction were compared with the classification criteria of Edwards and Ewing. Tetracycline and sulfadimethoxine were found to be highly ineffective at in vitro inhibition of the E. coli of piglets origin. The majority of E. coli were susceptible to amikacin, chloramphenicol and gentamicine. 89 (89.0%) of 100 strains of E. coil were resistant to one or more drugs. The organisms resistant to 20 or 3 drugs were 54(60.6%) of 89 strains, whereas 16(17.9%) strains were found to be resistant to one drug. 55(61.8%) out of 89 drug resistance strains carried R factors($R^+$) which were transfer-able to the recipients by conjugation.

• Journal of Food Hygiene and Safety
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• v.34 no.2
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• pp.212-218
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• 2019

The process of establishing domestic standards on hazardous substances in food safety regulations requires harmonization with standards from the Codex Alimentarius Commission (CAC). For this purpose, food classification by the CAC (Codex Classification of Foods and Animal Feeds) also needs to be clearly understood. Therefore, this paper aimed to introduce the Codex Classification on cereal grains, nuts/seeds and herbs/spices because revisions of the Codex were completed in 2017 for cereal grains and in 2018 for nuts/seeds and herbs/spices. The revised Codex Classification on those foods is briefly summarized as follows. Cereal grains in the domestic food classification by the Ministry of Food and Drug Safety, Korea (MFDS) corresponds to the Codex Group 020 cereal grains with six subgroups. The MFDS's nuts and seeds classification corresponds to three groups in the Codex, namely, Group 022 (tree nuts with no subgroups), Group 023 (oilseeds and oilfruits with 5 subgroups), and Group 024 (seeds for beverages and sweets with no subgroups). The food commodities of herbs and spices are included in two Codex groups, Group 027 (with 3 subgroups) and Group 028 (with 9 subgroups). The number of Codex commodity codes assigned to food commodities was 27 for Group 020, 32 for Group 022, 46 for Group 023, 4 for Group 024, 127 for Group 027 and 138 for Group 028. In between the Codex Classification and the MFDS's classification, some differences are shown. For example, the MFDS did not create a subgroup under groups of cereal grains and herbs. The MFDS classified peanuts into the nut group, though a separate group for oilseeds is present, while the Codex classified peanuts into the oilseed and oilfruit group. In addition, there is also a separate group of "plants, others" present in the MFDS's classification. Therefore, care is needed in using the Codex Classification.

• The Korean Journal of Applied Statistics
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• v.22 no.5
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• pp.1097-1102
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• 2009

Classification of subjects with unknown distribution in small sample size setup may involve order-restricted constraints in multivariate parameter setups. Those problems makes optimality of conventional likelihood ratio based statistical inferences not feasible. Fortunately, Roy (1953) introduced union-intersection principle(UIP) which provides an alternative avenue. Redescending M-estimator along with that principle yields a considerably appropriate robust testing procedure. Furthermore, conditionally distribution-free test based upon exact permutation theory is used to generate p-values, even in small sample. Applications of this method are illustrated in simulated data and read data example (Lobenhofer et al., 2002)

• Neonatal Medicine
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• v.16 no.1
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• pp.1-9
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• 2009

Seizures are the most common clinical manifestation of a neurologic insult during the neonatal period. Neonatal seizures continue to present a diagnostic and therapeutic challenge to pediatricians because the recognition and classification of neonatal seizures remains problematic, particularly when clinicians rely only on clinical criteria. Neonatal seizures can permanently disrupt neuronal development, induce synaptic reorganization, alter plasticity, and "prime" the brain to increased damage from seizures later in life. Since neonatal seizures, particularly status epilepticus, predict an increased risk for later epilepsy and other neurologic sequelae, accurate diagnoses are needed for aggressive antiepileptic drug use. The present review summarizes the pathophysiology, etiology, and diagnosis of neonatal seizures.

• Korean Journal of Pharmacognosy
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• v.22 no.3
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• pp.145-155
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• 1991

Peroxides in natural products have been recently received a considerable attention due to their various biological and pharmacological properties. Nearly 300 peroxides have been isolated and structually characterized from natural sources, mainly as constituents of Compositae and marine sponge, and occur randomly in about 10 other plant families. Among peroxides studied, sesquiterpene endoperoxide, quinghaosu, has been already clinically applied as a new antimalarial drug. Based on the peroxides reported, structural classification, natural distribution and biological and pharmacological activities are reviewed. Color reagent and spectroscopic identification of peroxide are also described.