• 한국독성학회:학술대회논문집
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• 한국독성학회 2006년도 추계학술대회
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• pp.80-86
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• 2006

Bioequivalence is a term in pharmacokinetics used to access the expected in vivo biological equivalence of two proprietary preparations of a drug. Bioequivalence studies are usually performed for generic drugs. Two pharmaceutical products are bioequivalent if they are pharmaceutically equivalent and their bioavailabilioes after administration in the same molar dose are similar. Bioequivalence is usually accessed by single dose in vivo studies in healthy volunteers and the reference product is usually the innovator product that is marketed. Regulatory definition of bioequivalence is based on the statistical analysis of thebioavailability of the reference and test product. In general, two products are evaluated as bioequivalent if the 90% confidence interval of the relative mean Cmaxand AUC of the test to reference product are within 80.00% to 125.00% in the fasting state. Key process in bioequivalence study is development and validation of bioanalytical method, determination of the drug concentration in the biosamples (usually plasma or serum) obtained from volunteers, calculation of the pharmacokinetic parameters and statistical analysis of the pharmacokinetic parameters. Although current guidelines and regulations do not require the bioequivalence studies to be done under good laboratory practice (CLP), the issues to perform the bioequivalence studies under GLP environment is emerged both from the regulatory and industry side. GLP perspectives of bioequivalence studiesare needed to be discussed in respect to achieve quality assurance in bioequivalence studies.

• 대한약침학회지
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• 제14권3호
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• pp.47-53
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• 2011

Objectives: This study was performed to analyse the effects of Sweet Bee Venom(SBV-purified melittin supported by G&V Co., the major component of honey bee venom) on the respiratory system in rats. Methods: All experiments were conducted at Biotoxtech Company, a non-clinical studies authorized institution, under the regulations of Good Laboratory Practice(GLP). Male rats of 5 weeks old were chosen for this study and after confirming condition of rats was stable, SBV was administered in thigh muscle of rats in 0.175, 0.35 and 0.7 mg/kg dosage. And checked the effects of SBV on the respiratory system using the whole body plethysmography. And respiratory rate, tidal volume and minute volume of rats were checked after administered SBV (melittin). Results: 1. In the measurement of respiratory rate, there were not observed any significant differences compared with control group. 2. In the measurement of tidal volume, there was not observed any significant differences compared with control group. 3. In the measurement of minute volume, 0.35mg/kg dosage group showed significant differences compared with control group. But we estimated that this result was caused by individual differences. Conclusions: Above findings suggest that SBV seems to be safe treatment in the respiratory system of rats. And further studies on the subject should be conducted to yield more concrete evidences.

• Clinical and Experimental Reproductive Medicine
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• 제48권4호
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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.

• Biomedical Engineering Letters
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• 제8권4호
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• pp.373-382
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• 2018

Since epileptic seizure is unpredictable and paroxysmal, an automatic system for seizure detecting could be of great significance and assistance to patients and medical staff. In this paper, a novel method is proposed for multichannel patient-specific seizure detection applying the earth mover's distance (EMD) in scalp EEG. Firstly, the wavelet decomposition is executed to the original EEGs with five scales, the scale 3, 4 and 5 are selected and transformed into histograms and afterwards the distances between histograms in pairs are computed applying the earth mover's distance as effective features. Then, the EMD features are sent to the classifier based on the Bayesian linear discriminant analysis (BLDA) for classification, and an efficient postprocessing procedure is applied to improve the detection system precision, finally. To evaluate the performance of the proposed method, the CHB-MIT scalp EEG database with 958 h EEG recordings from 23 epileptic patients is used and a relatively satisfactory detection rate is achieved with the average sensitivity of 95.65% and false detection rate of 0.68/h. The good performance of this algorithm indicates the potential application for seizure monitoring in clinical practice.

• 대한한의학회지
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• 제44권3호
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• pp.29-38
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• 2023

Objectives: This study aimed to investigate the acute oral toxicity of 77 herbal formulas and performed in male and female Sprague-Dawley (SD) rats as per the guidelines mentioned in Ministry of Food and Drug Safety. Methods: Each sex of SD rat were administered a single dose (2000 or 5000 mg/kg) of 77 herbal formulas via oral gavage; the control group received vehicle only. After administration, the mortality, clinical signs, gross findings, and body weight were followed up for 15 days. Results: After administration of 77 herbal formulas, mortality, clinical signs, body weight changes, and gross findings related to the test substances were not observed in both male and female groups. Conclusion: Our results demonstrate the single-dose oral administration of 77 herbal formulas produced no mortality indicating the approximate lethal dose is greater than 2000 or 5000 mg/kg body weight.

• Environmental Analysis Health and Toxicology
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• 제31권
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• pp.2.1-2.4
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• 2016

Objectives In this study, we investigated the biodegradation features of 4 perfluorooctanesulfonate (PFOS) alternatives developed at Changwon National University compared to those of PFOS. Methods Biodegradation testing was performed with microorganisms cultured in the good laboratory practice laboratory of the Korea Environment Corporation for 28 days following the Organization for Economic Cooperation and Development guidelines for the testing of chemicals (Test No. 301 C). Results While $C_8F_{17}SO_3Na$, PFOS sodium salt was not degraded after 28 days, the 4 alternatives were biodegraded at the rates of 20.9% for $C_{15}F_9H_{21}S_2O_8Na_2$, 8.4% for $C_{17}F_9H_{25}S_2O_8Na_2$, 22.6% for $C_{23}F_{18}H_{28}S_2O_8Na_2$, and 23.6% for $C_{25}F_{17}H_{32}O_{13}S_3Na_3$. Conclusions $C_{25}F_{17}H_{32}S_3O_{13}Na_3$, $C_{23}F_{18}H_{28}S_2O_8Na_2$, and $C_{15}F_9H_{21}S_2O_8Na_2$ were superior to PFOS in terms of biodegradation rates and surface tension, and thus they were considered highly applicable as PFOS alternatives. Environmental toxicity, human toxicity, and economic feasibility of these compounds should be investigated prior to their commercialization.

• International Journal of Industrial Entomology and Biomaterials
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• 제32권1호
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• pp.12-25
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• 2016

Recently, research investment in the improvement of food safety as a food source and specializing of nutritional source of edible insects is being actively conducted. Cricket especially has been attracting considerable interest in entomophagy; however, research on the safety assessment of cricket is limited. This study investigated the effects of cricket ethanol extract when orally administrated in Sprague-Dawley rats. Here, we performed a 4 wk repeated oral dose toxicity test in Sprague-Dawley rats following the Organization for Economic Cooperation and Development test guidelines 407 under Good Laboratory Practice regulation. Rats were randomly allocated 4 groups: vehicle control, 250, 500, 1,000 mg/kg test groups and administrated based on body weight for 28 d. The animals were observed for mortalities and clinical signs, body weight changes, food and water consumption. At the end of treatment period, blood and urine were collected and analyzed. Subsequently, the animals were sacrificed and subjected to gross pathological examination and organ weight measurement. The organs were preserved for histopathological examination. The results showed that there were no systemic toxicological effects related with the cricket ethanol extract in the 4 wk oral repeated dose toxicity study. It is considered that NOAEL of cricket ethanol extract is greater than 1,000 mg/kg/d and there was no target organ detected.

• 대한치과기공학회지
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• 제20권1호
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• pp.121-138
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• 1998

With 1002 students around 8 colleges nationwide joining, the survey was on their knowledge before entering their school, and thereafer, the degree of their satisfaction in their major and professors & lectures. 1. When they chose their major, the most influential was their parents and relatives, the largest number of 435(43.5%) replied, About the motivation for selection their jajor, 454(45.4%) answered the most it seemed to be a bright future specialty. On that question, more freshmen(51.0%) answered theyu expected good trend than sophomores and juniors and more women students(48.8%) did so than men ones.(P<.05) 2. While 619(61.8%) were familiar with major before applying, only 68(6.85%) knew their major very well at that time. More freshmen(62.5%) applied in the state of well-knowing what their major is than sophomores and juniors did.(P<.01) More women students(40.9%) applied not knowing it than the counterpart. About the time for choice, 795(79.5%) answered the most one of application days. More women students(81.0%) chose their major during the application time(P<.01) 3. The satisfaction survey shows 438(43.8%) are satisfied and 165(16.5%) are not. More men students(47.2%) are satisfied.(P<.01) The factor their satisfaction is their major come together with aptitude(44.7%), 196ppl), and the dissatisfaction factor is the difficulty of the theory and practice.(30.8%, 171ppl) 4. If they could change their major, 454(46.6%) wouldn't do so, while 541(54.4%) would shift their major to other fields. More freshmen(49.5%) wouldn't change than sophomores and juniors. Neither did more men students(4938%) than women. Within the same grade, there's no meaninful difference.(P<.01) 5. On the satisfaction in the lectures of the professors of their major, 464(46.5%) said the lecutres are excellent, 102(10.2%), they are not. About the lectures of the liberal subjects, 193(19.4%) said are excellent, 365(36.6%) are not.

• 대한약침학회지
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• 제21권2호
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• pp.104-111
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• 2018

Objective:This study is to evaluate both the single-dose intravenous injection toxicity and the approximate lethal dose of Water-soluble Danggui Pharmacopuncture (WDP) in Sprague-Dawley (SD) rats. Methods: Toxicity experiments were conducted at Good Laboratory Practice (GLP) laboratory in Biotoxtech Co., according to the regulations of GLP. WDP injection of dose 0.125, 0.25, and 0.5 mL/animal were experimental groups and normal saline injection group was control group. WDP and normal saline were injected once to 6- week old 5 male and 5 female SD rats at the tail veins at approximately 2 mL/min. During 14 days after the injection, general symptoms were observed and weight were measured. After the observation period, hematological and blood biochemical examination, macroscopic autopsy, topical resistance test at the injection area were performed. Results: RThe WDP 0.5 mL/animal injection group in 4 cases of male rats and all cases of female rats showed hematuria 30 minutes after the administration. However, after 1 hour, no more abnormal general symptoms were observed. The WDP did not affect weight, hematological and blood biochemical examination, macroscopic autopsy, and topical resistance test at the injection area. Conclusion: WDP single dose intravenous injection results showed that WDP have no toxic effects and a lethal dose of WDP should be over 0.5 mL/animal in male and female rats under the study condition. So WDP may be safe.

• 대한약침학회지
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• 제18권2호
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• pp.42-50
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• 2015

Objectives: The aims of the study were to test the single- dose intravenous toxicity of Daebohwalryeok pharmacopuncture (DHRP) in Sprague-Dawley (SD) rats and to estimate the crude lethal dose. Methods: The experiments were conducted at Biotoxtech Co., a Good Laboratory Practice (GLP) laboratory, according to the GLP regulation and were approved by the Institutional Animal Care and Use Committee of Biotoxtech Co. (Approval no: 110156). The rats were divided into three groups: DHRP was injected into the rats in the two test groups at doses of 10 mL/kg and 20 mL/kg, respectively, and normal saline solution was injected into the rats in the control group. Single doses of DHRP were injected intravenously into 6 week old SD rats (5 male and 5 female rats per group). General symptoms were observed and weights were measured during the 14 day observation period after the injection. After the observation period, necropsies were done. Then, histopathological tests were performed. Weight data were analyzed with a one-way analysis of variance (ANOVA) by using statistical analysis system (SAS, version 9.2). Results: No deaths and no statistical significant weight changes were observed for either male or female SD rats in either the control or the test groups during the observation period. In addition, no treatment related general symptoms or necropsy abnormalities were observed. Histopathological results showed no DHRP related effects in the 20 mL/kg DHRP group for either male or female rats. Conclusion: Under the conditions of this study, the results from single-dose intravenous injections of DHRP showed that estimated lethal doses for both male and female rats were above 20 mL/kg.