• 한국응용약물학회:학술대회논문집
• /
• 한국응용약물학회 2006년도 Proceedings of The Convention
• /
• pp.139-145
• /
• 2006

Kaneka Corporation (Kaneka) has been manufacturing CoQ10 under GMP regulation since 1977. Kaneka has a sophisticated quality control system and has been supplying high quality CoQ10 materials to the worldwide customers (Kaneka CoQ10) for about 30 years. Kaneka CoQ10 is characterized by a lot of safety data, which are derived from clinical trials with healthy volunteers (single-dose and 4-week multi-dose safety studies), animal studies (13-week sub-chronic study in dogs and 52-week chronic study in rats), three types of mutagenicity test, six type of skin irritation test (for cosmetics), and others. The risk assessment of CoQ10 was performed by Council for Responsible Nutrition (USA). They reviewed many of available clinical data including clinical trials using Kaneka Q10, and concluded that the upper level for supplements (ULS) of CoQ10 is 1,200 mg/day (Hathcock and Shao. 2006, Regulatory Toxicology and Pharmacology, 45, 282 - 288).

• 대한약학회:학술대회논문집
• /
• 대한약학회 2003년도 Proceedings of the Convention of the Pharmaceutical Society of Korea Vol.1
• /
• pp.172.1-172.1
• /
• 2003

3-Monochloro-1 ,2-propanediol (3-MCPD) produced during the acid hydrolysis of vegetable proteins (ex. soybean products) is food-contaminant material detected in acid-hydrolysed soy, bread, water, et al. 3-MCPD is currently being a matter of concern to safety. The nephrotoxicity of 3-MCPD and 3-MCPD metabolites has been reported to result from accumulating of metabolites in kidney tubules and inhibiting of renal metabolism of glucose and lactate. (omitted)

• 대한한의학방제학회지
• /
• 제20권2호
• /
• pp.55-63
• /
• 2012

Objectives : This study was conducted to investigate the safety of Bangpungtongsung-san in rats. Methods : The safety of this prescription on acute toxicity was evaluated by single dose toxicity study. Rats were orally administrated in a single dose of 0 and 2,000 mg/kg(limited dose) Bangpungtongsung-san. There were 7 rats in each groups. All animals were sacrificed after 14 days of treatment. After single administration, mortality, clinical signs, and body weight changes were observed for 14 days. Three parameters(autopsy finding, clinical chemistry, and hematology) were tested on the last day. Results : In this study with rats, Bangpungtongsung-san treatment did not show any acute toxicity. No mortality was noted for 14 days of treatment. There were no adverse effects on clinical signs, body weight changes, and autopsy finding at all treatment groups. The clinical chemistry parameters attesting to liver and kidney functions as well as the hematological parameters were within the normal ranges. Conclusions : It is considered that $LD_{50}$ of Bangpungtongsung-san is over 2,000 mg/kg in oral administration by rats. This finding of the safety of Bangpungtongsung-san is expected to strengthen the position of this prescription as nontoxic medicine.

• Clinical and Experimental Pediatrics
• /
• 제60권2호
• /
• pp.50-54
• /
• 2017

Purpose: The aims of this study were to evaluate the safety and pharmacokinetics of levetiracetam (LEV) in neonates with seizures and to establish a population pharmacokinetics (PPK) model by using the software NONMEM. Methods: A retrospective analysis of 18 neonatal patients with seizures, who were treated with LEV, including 151 serum samples, was performed. The mean loading dose was 20 mg/kg, followed by a mean maintenance dose of 29 mg/kg/day. Results: Seventeen neonates (94%) had seizure cessation within 1 week and 16 (84%) remained seizure-free at 30 days under the LEV therapy. The mean serum concentration of LEV was $8.7{\mu}g/mL$. Eight samples (5%) were found above the therapeutic range. No serious adverse effects were detected. In the PPK analysis for Korean neonates, the half-life was 9.6 hours; clearance, 0.357 L/hr; and volume of distribution, 4.947 L, showing differences from those in adults. Conclusion: LEV is a safe and effective option for the treatment of neonatal seizures with careful therapeutic drug monitoring.

• Biomolecules & Therapeutics
• /
• 제23권4호
• /
• pp.386-389
• /
• 2015

Sibutramine is an anorectic that has been banned since 2010 due to cardiovascular safety issues. However, counterfeit drugs or slimming products that include sibutramine are still available in the market. It has been reported that illegal sibutramine-contained pharmaceutical products induce cardiovascular crisis. However, the mechanism underlying sibutramine-induced cardiovascular adverse effect has not been fully evaluated yet. In this study, we performed cardiovascular safety pharmacology studies of sibutramine systemically using by hERG channel inhibition, action potential duration, and telemetry assays. Sibutramine inhibited hERG channel current of HEK293 cells with an $IC_{50}$ of $3.92{\mu}M$ in patch clamp assay and increased the heart rate and blood pressure ($76{\Delta}bpm$ in heart rate and $51{\Delta}mmHg$ in blood pressure) in beagle dogs at a dose of 30 mg/kg (per oral), while it shortened action potential duration (at $10{\mu}M$ and $30{\mu}M$, resulted in 15% and 29% decreases in $APD_{50}$, and 9% and 17% decreases in $APD_{90}$, respectively) in the Purkinje fibers of rabbits and had no effects on the QTc interval in beagle dogs. These results suggest that sibutramine has a considerable adverse effect on the cardiovascular system and may contribute to accurate drug safety regulation.

• Biomolecules & Therapeutics
• /
• 제8권2호
• /
• pp.179-183
• /
• 2000

To determine biosafety of fluorosilicic acid as a source of fluoride, we carried out acute toxicity and general pharmacological studies using mouse. Fluorosilicic acid had little effects on general behavior, pain response, convulsion, skeletal muscle function and intestinal mobility as compared to controls. It had either little adverse effects on alkaline phosphatase and collagen levels in osteoblast cells. This study supports the safety of fluorosilicic acid in animals.

• 한국생명과학회:학술대회논문집
• /
• 한국생명과학회 2003년도 제39회 학술심포지움
• /
• pp.59-59
• /
• 2003

• Archives of Pharmacal Research
• /
• 제18권5호
• /
• pp.320-324
• /
• 1995

Pretreatment of Glycyrrhizae Radix(GR) to male Sprague-Dawley rats was demonstrated to increase excretion of acetaminophen-glucuronide ocnjugate when bile nad urine were assayed after administration of acetaminophen. In order to study the effect of GR on the glucuronidation in rats, we examined enzymatic activities of hepatic UDP-glucuronosyl-transferases (UDP-GT1 and UDP-GT2) and intracellular concentrations of hepatic UDP-glucuronic acid (UDP-GA), upon the administration of GR (1 g/kg body weight, p.o.) or glycyrrhizin (23 mg/kg body weight, p.o.) a major component of GR, for 6 days. GR and glycyrrhizin caused increases in specific activities of UDP-GT2 111% and 96% respectively. Specific activity of UDP-GT1 was increased 25% by GR treatment whereas it was not significantly increased by glycyrrhizin. Concentrations of UDP-GA were increased 257% by GR and 484% by glycyrrhizin. These data indicate that GR activated glucuronidation and thus suggest the possibility that GR may influence detoxification of xenobiotics in rat liver.

• Translational and Clinical Pharmacology
• /
• 제26권4호
• /
• pp.172-176
• /
• 2018

Mandatory registration of clinical trials in public registry can ensure the transparency of clinical trials. Public clinical trial registry of can provide current chronological and geographical distribution of clinical trial throughout the country. We used public clinical trial registry provided by Ministry of Food and Drug Safety to analyze current status of clinical trial from 2014 to 2016 in South Korea. The number of clinical trials in antineoplastic and immunomodulating agents area was the greatest, followed by cardiovascular system and antiinfectives for systemic use as a whole. From 2014 to 2016, overall number of clinical trials decreased while the number of phase I clinical trials increased. Seoul accounted for more than half number of clinical trials in Korea. Supports for clinical trials in non-metropolitan area needs to be considered.

• 한국응용약물학회:학술대회논문집
• /
• 한국응용약물학회 1994년도 춘계학술대회 and 제3회 신약개발 연구발표회
• /
• pp.336-336
• /
• 1994

In order to develope the in vitro short term screen-ing method for carcinogen, we studied a purification method for thymine glycol in oxidaized DNA. Thymine glycol (5,6-dihydroxy-5, 6-dihydrothymine) is the major stable radiolysis poduct in thymine by chemical oxidants and ionzing radiation and it is a useful biomarker among oxidized DNA adducts, related with carcinogenests. Standard thymine glycol was prepared by oxidation of 〔$^3$H〕 thymine with KMnO$_4$ followed by purification with HPLC-LSC system and it was assayed by TLC and gas chromatography-MSD. 〔$^3$H〕 DMA adducts was isolated from E. coli (wild type ) treated with oxidative agents such as benzo(a)pyrene, adriamycin, aflatoxin B$_1$ and KBrO$_3$. These oxidative agents generated free radicals in cells by oxidative metabolism. As a result, thymine glycol was produced in cultured E. coli by four chemicals. This result shows that this methodology should be useful tool in screening oxidative carcinogen.