• Toxicological Research
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• v.1 no.1
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• pp.31-41
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• 1985

The Japanese Good Laboratory Practice (GLP) Standard on Drugs was finalized as a guideline and implemented in April, 1983. This standard is intended to ensure the quality and integrity of the data from nonclinical toxicity studies submitted to the Ministry of Health and Welfare in support of applications for approval to manufacture or import new drugs or to be used in the reevaluation of previously approved drugs. The standard includes a guideline for organizational matters, personnel, facility, equipment, testing operation, documentation and conduct of studies. Principles and influences of implementation of Japanese GLP will be discussed briefly in comparison with foreign GLPs.

• Journal of the Korean Applied Science and Technology
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• v.41 no.2
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• pp.172-187
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• 2024

In good laboratory practice (GLP), analytical method validation prior to toxicity testing is important in terms of concentration setting and sample preparation. The testing agency performed validation of the two requested test substances using high-performance liquid chromatography (HPLC), and as a result, the analysis satisfied the criteria for specificity, system suitability, linearity, intra-day reproducibility, homogeneity, stability, concentration analysis, and quality control. The method was established and validated. However, the content of standard substances in the test report of the requesting institution was found to be 1.34 and 1.17 times higher than the results of the testing institution, confirming that deriving results through validation of analysis methods suitable for GLP is important in terms of securing reliability and stability.

• Journal of Intelligence and Information Systems
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• v.10 no.3
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• pp.39-57
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• 2004

Many dairy producers periodically receive information about their bulk tank milk with reference to bulk tank somatic cell counts, standard plate counts, and preliminary incubation counts. This information, when collected over a period of time, in combination with bulk tank mastitis culture reports can become a significant knowledge base. Several guidelines have been proposed to interpret farm bulk tank milk bacterial counts. However many of the suggested interpretive criteria lack validation, and provide little insight to the interrelationship between different groups of bacteria found in bulk tank milk. Also the linguistic terms describing bulk tank milk quality or herd management status are rather vague or fuzzy such as excellent, good or unsatisfactory. The objective of this paper was to develop a set of fuzzy descriptors to evaluate bulk tank milk quality and herd's milking practice based on bulk tank milk microbiology test results. Thus, fuzzy logic based reasoning methodologies were developed based on fuzzy inference engine. Input parameters were bulk tank somatic cell counts, standard plate counts, preliminary incubation counts, laboratory pasteurization counts, non agalactiae-Streptococci and Streptococci like organisms, and Staphylococcus aureus. Based on the input data, bulk tank milk quality was classified as excellent, good, milk cooling problem, cleaning problem, environmental mastitis, or mixed with mastitis and cleaning problems. The results from fuzzy reasoning would provide a reference regarding a good management practice for milk producers, dairy health consultants, and veterinarians.

• The Journal of Korea Institute of Information, Electronics, and Communication Technology
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• v.15 no.6
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• pp.477-484
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• 2022

In this study, the cartridge part of the focused ultrasound stimulation system was used as a sample to conduct a skin irritation test and a skin sensitization test through animal experiments among the tests related to GLP (Good Laboratory Practice), a medical device safety evaluation standard. The test was conducted after IACUC approval using 6 female New Zeland White Rabbits. The polar and non-polar stimulation indices were all '0.0'. In addition, in the case of skin sensitization evaluation, 30 guinea pigs approved by IACUC were divided into control and experimental groups, and all induction and induction steps were applied using the eluate itself without separate dilution of the test sample and blank test solution. As a result of the experiment, the skin reaction grade of the control animal was 0 grade, and there was no animal showing more than 1 grade in the skin reaction of the test animal. As a result of both tests, no abnormal skin symptoms were observed, and when applied to the human body to treat patients, the test materials used in the tests will investigate the stability of whether any diseases that cause skin abnormal symptoms will occur.

• Clinical and Experimental Reproductive Medicine
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• v.48 no.4
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• pp.273-282
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• 2021

Since December 2019, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has spread rapidly, resulting in a pandemic. The virus enters host cells through angiotensin-converting enzyme 2 (ACE2) and transmembrane protease serine subtype 2 (TMPRSS2). These enzymes are widely expressed in reproductive organs; hence, coronavirus disease 2019 (COVID-19) could also impact human reproduction. Current evidence suggests that sperm cells may provide an inadequate environment for the virus to penetrate and spread. Oocytes within antral follicles are surrounded by cumulus cells, which rarely express ACE2 and TMPRSS2. Thus, the possibility of transmission of the virus through sexual intercourse and assisted reproductive techniques seems unlikely. Early human embryos express coronavirus entry receptors and proteases, implying that human embryos are potentially vulnerable to SARS-CoV-2 in the early stages of development. Data on the expression of ACE2 and TMPRSS2 in the human endometrium are sparse. Moreover, it remains unclear whether SARS-CoV-2 directly affects the embryo and its implantation. A study of the effect of SARS-CoV-2 on pregnancy showed an increase in preterm delivery. Thus, vertical transmission of the virus from mother to fetus in the third trimester is possible, and further data on human reproduction are required to establish this possibility. Based on analyses of existing data, major organizations in this field have published guidelines on the treatment of infertility. Regarding these guidelines, despite the COVID-19 pandemic, reproductive treatment is crucial for the well-being of society and must be continued under suitable regulations and good standard laboratory practice protocols.

• Journal of Pharmacopuncture
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• v.12 no.4
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• pp.33-50
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• 2009

Objectives : This study was conducted to confirm validation and stability of concentration analysis method of pure melittin (Sweet Bee Venom-Sweet BV) extracted from the bee venom by utilizing protein isolation method of gel filtration. Methods : All experiments were conducted at Biotoxtech, a non-clinical studies authorized institution, under the regulations of Good Laboratory Practice (GLP). Standard solutions of melittin (SIGMA, USA) and test substances were dispensed and were analyzed with HPLC for Sweet BV to secure the validation of analysis. Results : 1. Measurement of system suitability of Sweet BV satisfied criterion of below 3%. 2. Confirming Linearity of Sweet BV in 10-200${\mu}g/m\ell$ solution yielded correlation coefficient (r) of 0.995 and accuracy of 85-115% which satisfy criterion. 3. Measurement of Specificity of Sweet BV didn't yield any substance affecting the peak of test substances, but detected at 21.22min verified as the test substance. 4. Confirming Intra-day of Sweet BV, accuracy and precision of 0.1, 100${\mu}g/m\ell$ were 105.70, 95.81 and 0.66, 0.73, respectively, satisfying both criteria of accuracy (85-115%) and precision (within 10%). 5. To measure Stability in autosampler, all samples used in Intra-day reproducibility sat in the autosampler for five hours and were re-analyzed. Both variability and precision satisfied the criteria. 6. Homogeneity of Sweet BV (0.1, 100${\mu}g/m\ell$) at upper, middle, and lower layers all satisfied the accuracy and precision criteria. 7. Stability of Sweet BV (0.1, 100${\mu}g/m\ell$) at room temperature for four hours and refrigerated for 7 days all satisfied the criterion. 8. For the measurement of Quality control, QC samples measured on the first and eighth day all satisfied accuracy and precision criteria. Conclusion : Above experiment data satisfies validation and stability of concentration analysis method of Sweet BV.

• Tuberculosis and Respiratory Diseases
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• v.83 no.3
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• pp.211-217
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• 2020

The gold standard method for diagnosis of tuberculosis is the isolation of Mycobacterium tuberculosis through culture, but there is a probability of cross-contamination in simultaneous cultures of samples causing false-positives. This can result in delayed treatment of the underlying disease and drug side effects. In this paper, we reviewed studies on false-positive cultures of M. tuberculosis. Rate of occurrence, effective factors, and extent of false-positives were analyzed. Ways to identify and reduce the false-positives and management of them are critical for all laboratories. In most cases, false-positive is occurring in cases with only one positive culture but negative direct smear. The three most crucial factors in this regard are inappropriate technician function, contamination of reagents, and aerosol production. Thus, to reduce false-positives, good laboratory practice, as well as use of whole-genome sequencing or genotyping of all positive culture samples with a robust, extra pure method and rapid response, are essential for minimizing the rate of false-positives. Indeed, molecular approaches and epidemiological surveillance can provide a valuable tool besides culture to identify possible false positives.

• Journal of the Korean Geotechnical Society
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• v.35 no.5
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• pp.5-19
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• 2019

Considering the natural phenomenon in which steep slopes ($65^{\circ}{\sim}85^{\circ}$) consisting of rock mass remain stable for decades, slopes steeper than 1:0.5 (the standard of slope angle for blast rock) may be applied in geotechnical conditions which are similar to those above at the design and initial construction stages. In the process of analysing the stability of a good to fair continuum rock slope that can be designed as a steep slope, a general method of estimating rock mass strength properties from design practice perspective was required. Practical and genealized engineering methods of determining the properties of a rock mass are important for a good continuum rock slope that can be designed as a steep slope. The Genealized Hoek-Brown (H-B) failure criterion and GSI (Geological Strength Index), which were revised and supplemented by Hoek et al. (2002), were assessed as rock mass characterization systems fully taking into account the effects of discontinuities, and were widely utilized as a method for calculating equivalent Mohr-Coulomb shear strength (balancing the areas) according to stress changes. The concept of calculating equivalent M-C shear strength according to the change of confining stress range was proposed, and on a slope, the equivalent shear strength changes sensitively with changes in the maximum confining stress (${{\sigma}^{\prime}}_{3max}$ or normal stress), making it difficult to use it in practical design. In this study, the method of estimating the strength properties (an iso-angle division method) that can be applied universally within the maximum confining stress range for a good to fair continuum rock mass slope is proposed by applying the H-B failure criterion. In order to assess the validity and applicability of the proposed method of estimating the shear strength (A), the rock slope, which is a study object, was selected as the type of rock (igneous, metamorphic, sedimentary) on the steep slope near the existing working design site. It is compared and analyzed with the equivalent M-C shear strength (balancing the areas) proposed by Hoek. The equivalent M-C shear strength of the balancing the areas method and iso-angle division method was estimated using the RocLab program (geotechnical properties calculation software based on the H-B failure criterion (2002)) by using the basic data of the laboratory rock triaxial compression test at the existing working design site and the face mapping of discontinuities on the rock slope of study area. The calculated equivalent M-C shear strength of the balancing the areas method was interlinked to show very large or small cohesion and internal friction angles (generally, greater than $45^{\circ}$). The equivalent M-C shear strength of the iso-angle division is in-between the equivalent M-C shear properties of the balancing the areas, and the internal friction angles show a range of $30^{\circ}$ to $42^{\circ}$. We compared and analyzed the shear strength (A) of the iso-angle division method at the study area with the shear strength (B) of the existing working design site with similar or the same grade RMR each other. The application of the proposed iso-angle division method was indirectly evaluated through the results of the stability analysis (limit equilibrium analysis and finite element analysis) applied with these the strength properties. The difference between A and B of the shear strength is about 10%. LEM results (in wet condition) showed that Fs (A) = 14.08~58.22 (average 32.9) and Fs (B) = 18.39~60.04 (average 32.2), which were similar in accordance with the same rock types. As a result of FEM, displacement (A) = 0.13~0.65 mm (average 0.27 mm) and displacement (B) = 0.14~1.07 mm (average 0.37 mm). Using the GSI and Hoek-Brown failure criterion, the significant result could be identified in the application evaluation. Therefore, the strength properties of rock mass estimated by the iso-angle division method could be applied with practical shear strength.