• Journal of the Korea Organic Resources Recycling Association
• /
• v.5 no.1
• /
• pp.15-23
• /
• 1997

Commercial inocula and mature compost were added separately to food wastes in order to compare the inoculating effect on garbage decomposition. Among commercial inocula available in the market, GM (Green Microorganisms) and EM (Effective Microorganisms) were selected as test inocula. Garbage decompostion were evaluated in Volatile Solid (VS) reduction and FDA (Fluorescein DiAcetate) hydrolysis activity. VS reduction with mature compost experiment was higher than that with GM-added one. VS reduction rates were about 32% with mature compost and 27% with GM. When food wastes were treated with GM and EM based on the manufacturer's specifications, GM-added and EM-added food wastes showed only 8% and 9% of VS reduction respectively, which are much lower than those with the mature compost. FDA hydrolysis activity increased during the first 10 days of active composting periods for the composting experiments, while it decreased continuously for the experiments based on manufacturer's specifications.

• The Korean Journal of Cytopathology
• /
• v.18 no.1
• /
• pp.1-12
• /
• 2007

Approximately 70% of cervical cancers are caused by HPV types 16/18 and thus the implementation of vaccination programmes with vaccines against HPV types 16/18 will have a major impact on the incidence of cervical cancer worldwide. However, this reduction will not be seen until several decades after full implementation of such vaccination programmes since the vaccines must be given to young adolescents before exposure to the virus and women who are already sexually active are not likely to be protected. Both GSK and Merck insist that even vaccinated women must continue to participate in regular cervical screening by the most sensitive method available since the vaccine can only give protection against up to 70% of cervical cancers. It is unlikely that the current vaccines will be modified to include additional high risk HPV types in the foreseeable future. While HPV testing is highly sensitive, it is not recommended for women under 30 years of age nor for vaccinated women. Additionally, HPV testing has poor specificity. The Digene Hybrid Capture 2 test is licensed for use only in conjunction with a cytology test, not as a stand-alone test, and the high risk panel has recognised cross reactivity with low risk HPV types. None of the other HPV test methods currently commercially available are FDA approved and all must be internally validated before use. This makes comparison of test results between laboratories difficult. The most sensitive and specific screening test currently available for women of all ages is the Cytyc ThinPrep System consisting of the ThinPrep Pap Test (TPPT) and the ThinPrep Imaging System (Imager). The TPPT was the first LBC system approved by the US FDA in 1996 and there are about 4,000 processors in use worldwide. The Imager was FDA approved in 2003 and over 350 systems are in routine use, mainly in the US. 40% of TPPT in the US are processed on Imager. There is clear evidence in peer reviewed literature that the Imager increases laboratory productivity by 100% and growing evidence that Imager detects more high grade SIL than the conventional smear or manual evaluation of TPPT. This aspect is particularly important since the number of cytological abnormalities will decrease as vaccination programmes are implemented. Cytotechnologists will see fewer and fewer abnormal smears and their skills will be put at risk. By doubling throughput, Imager will allow cytotechnologists to maintain their skills.

• Korean Journal of Animal Reproduction
• /
• v.12 no.2
• /
• pp.84-90
• /
• 1988

This study was done with mouse embryos to determine effects of the freezing media with or without 10% sucrose, and seeding methods (pincette, no seeding, liquid nitrogen gas phase and copper wire coiled straw) on embryo survival were determined using the FDA test. The summarized results are the following. 1. The FDA score found with copper wire coiled straw, no seeding, pincette and liquid nitrogen gas phase was 3.6, 3.6, 3.3 and 3.0, respectively. There were no significant differences. 2. The embryo score shows higher (P<0.05) survival rate using a freezing medium with sucrose than the one without it. Among the seeding procedure, better resutls are copper wire coiled straw and no seeded. 3. The results suggest that copper wire coiled seeding no seeding be as good as seeding when the mouse embryos were frozen in a liquid nitrogen container using both the freezing and dilution media containing 10% sucrose.

• Korean Journal of Animal Reproduction
• /
• v.12 no.2
• /
• pp.77-83
• /
• 1988

This study was done with mouse embryo to assess effects of freezing media containing sucrose, freezing metods(1-F, 0.3$^{\circ}C$/min;2-F, 3-5$^{\circ}C$/min;3-F, 15$^{\circ}C$min;4-F, LN2 vapour) and cell freezers on the embryo survival determined using the FDA test. The results are summarized as follows. 1. The FDA score obtained with 1, 2, 3 and 4-F was 3.8, 3.6, 3.2 and 3.2, respectively. There was a significant difference(P<0.05) between 1-F, 3-F and 2-F, 4-F. 2. The score at the morular stage(3.8) higher(P<0.005) than the blastocyst stage of embryos(3.2). 3. No difference (P>0.05) was found between the score obtained with a automatic embryo freezer(4.0) and a liquid nitrogen container(3.7).

• Korean Journal of Food Science and Technology
• /
• v.10 no.2
• /
• pp.250-257
• /
• 1978

Functional additives such as methyl silicone, TBHQ and BHA/BHT have been evaluated for their effects on storage and frying stabilities of the vegetable salad oil. All test results strongly suggest that methyl silicone improved the frying stability and TBHQ improved the storage stability. BHA/BHT improved neither storage stability, nor frying stability of the vegetable saladoil. Based on the test results, it is recommended that methyl silicone in the range of $1.0{\pm}0.5ppm$ and TBHQ in the range of 200ppm be added to the vegetable salad oil for the improvement of frying and storage stabilities.

• Proceedings of the Korea Society of Environmental Toocicology Conference
• /
• 2002.10a
• /
• pp.107-116
• /
• 2002

GLP regulations were initially “promulgated to address assuring the validity of data in the wake of investigations by EPA and FDA during the mid -1970's which revealed that some studies submitted to the agencies had not been conducted in accordance with acceptable laboratory practices.” [1] In the early 1970s, results of an investigation by the FDA in about 40 laboratories revealed many cases of badly managed studies, poor training of personnel and some cases of deliberate fraud. The general findings were that there were poorly trained study directors and study personnel, poorly designed protocols, protocols not followed, procedures not conducted as described, raw data badly collected, data not correctly identified, data without traceability, data not verified and approved by responsible persons, lack of standardised procedures, poor animal husbandry, inadequate characterisation of test items and test systems, inadequate resources, equipment poorly calibrated or otherwise qualified, reports not sufficiently verified, not an accurate account of the actual study, not a proper reflection of raw data and inadequate archiving of data. These problems are not just past history, since they resurface time and time again, even in quite recent times as the experience of GLP inspectors shows [1]. The GLPs specify minimum practices and procedures in order to ensure the quality and integrity of data submitted in accordance with a regulatory requirement

• Korean Journal of Clinical Laboratory Science
• /
• v.50 no.1
• /
• pp.20-28
• /
• 2018

Tuberculosis (TB) is a bacterial infection disease caused by members of the species Mycobacterium tuberculosis (MTB) complex. Approximately one third of the world's population is infected with TB. In Korea, approximately 40,000 new patients are identified each year. Moreover, infections from non-tuberculous mycobacteria (NTM) have also increased. In the diagnosis of TB and NTM, traditional bacterial cultures are required for 3 to 4 weeks. Therefore, rapid and accurate diagnostic tests for TB and NTM are needed. To distinguish between TB and NTM, a range of diagnostic methods have been developed worldwide. In vitro diagnostic assays are constantly being developed to meet the increasing need for the rapid and accurate identification for TB and NTM. On the other hand, the performance evaluations of in vitro diagnostic reagents for TB and NTM are lacking. Recently, the Korea Food and Drug Administration (KFDA) issued a guideline for in vitro diagnostic reagents for MTB and NTM. Here, this study analyzed the performance of currently developed in vitro diagnostic reagents for TB and NTM in the US FDA. This analysis of US FDA approved molecular assays could serve as a useful reference for an evaluation of the reagent performance of TB and NTM.

• Journal of the Korea Academia-Industrial cooperation Society
• /
• v.16 no.6
• /
• pp.4328-4334
• /
• 2015

We determined a method to determine marine planktonic organism viability using Evan's blue, Aniline blue, and 5-choromethyfluorescein diacetate (CMFDA). The Evan's blue and Aniline blue methods produced bright blue light for dead phytoplankton and zooplankton and were the best dyes to detect dead cells. The staining efficiency of Evan's blue and Aniline blue were ${\geq}90%$ of the original field sample. However, it was difficult to test the efficiency of a ship's ballast water treatment system because detection of living cells. In contrast, the CMFDA method, which is based on measuring cell esterase activity using a fluorimetric stain, was the best dye to detect live cells of almost all phytoplankton species, and staining efficiency was 70%. The CMFDA method is similar to the fluorescein diacetate (FDA) staining method. Therefore, we estimated viability of phytoplankton species using a double-staining method by combining CMFDA and FDA to determine optimum staining efficiency. As a result, the frequency of dying cells based on the double-staining method was 95%, which was significantly higher than that of single CMDFA staining. Our results suggest that a CMDFA + FDA assay is more effective to determine survival of marine plankton and that this method was applicable to investigate the efficacy of a ship's ballast water treatment system.

• Journal of the Korea Academia-Industrial cooperation Society
• /
• v.21 no.10
• /
• pp.471-479
• /
• 2020

In this paper, we analyze features of radical innovative businesses using their patents. Although patents have been used to evaluate outcomes of businesses from the 1980s, it is challenging to use patents for radical innovations. We examined the possibility of taking advantage of patents for an indicator that represents a radical innovation in pharmaceutical industry. To this end, we collected FDA approval data from the U.S. Food and Drug Administration and patent data of 18 pharmaceutical companies. For analysis, we utilized the network centrality analysis and Wilcoxon signed ranked test, which is a non-parametric statistical hypothesis test used to compare two related samples. We observed that a radical innovative company typically cooperates with other research groups, such as universities and companies, and acts as a hub for connectivity in pharmaceuticals. Also, we found that there are differences in centrality between radical firms and non-radical firms. Thus, we expect that the results of this study will help in developing strategies for research and development of pharmaceutical companies and identifying factors affecting radical innovation in the future.

• Toxicological Research
• /
• v.27 no.3
• /
• pp.133-135
• /
• 2011

The FDA guidance focuses on the use of the NOAEL to establish the maximum recommended starting dose. The majority of NOAEL has been described inaccurately or incompletely in final reports for 90-days repeated dose toxicity test based on GLP (good laboratory practice) regulation. This is the most serious one of reasons for why most pharmaceutical companies targeting global markets have disregarded the final report produced from GLP facilities in Korea. The problems in deciding NOAEL reflected in the final reports are mainly due to the followings; 1) Inaccurate description or use of NOEL, NOAEL and LOAEL, 2) Insufficient and inappropriate interpretations in findings from toxicity test. This paper is intended to provide the insight into distinguishing NOAEL from NOEL and LOAEL, and into classifying findings from toxicity test. Here, the three step method is newly suggested by applying the weight-based classification to the NOEL, NOAEL and LOAEL based on the findings.