• Toxicological Research
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• v.12 no.1
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• pp.101-111
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• 1996

The local irritation studies of DA-3285, recombinant human erytropoietin(rHu-EPO), were carried out in rabbits after the following treatment; single application into the conjunctival sac of the eye, single subcutaneous injection, 7-day repeated subcutaneous injection and 8-day repeated infusion into the ear vein. Also, the local irritancy of DA-3285 leaked around vein was studied in mice by single perivascular injection. The results obtained were as follows. In the result of ocular irritation test, DA-3285 could be considered as a non-irritating material. In single and 7-day repeated subcutaneous irritation test, the irritancy of DA-3285 was not so much different from that of saline. The vascular irritancy of DA3285 by 8-day repeated infusion was negligible and similar to that of saline. And the irritancy of DA3285 by perivascular injection was comparable to that of saline. These results indicate that DA-3285 has no irritating activity when injected through subcutaneous or intravenous route for clinical practice as 3.5% solution.

• Biomolecules & Therapeutics
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• v.3 no.1
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• pp.63-71
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• 1995

The local irritation studies of DA-3002, an authentic recombinant human growth hormone (rhGH), were carried out in rabbits after the following treatment ; application into the conjunctival sac of the eye (single), single subcutaneous and intramuscular injection, 7-day repeated subcutaneous and intramuscular injection. The results obtained were as follows. In the result of ocular irritation test, 0.16% solution of DA-3002 could be considered as a non-irritating material. In single subcutaneous and intramuscular irritation test, the irritancy of 0.16% DA-3002 solution was not so much different from that of saline. The local irritation of DA-3002 by 7-day repeated injection was negligible and similar to that of saline by both subcutaneous and intramuscular routes. These results suggest that DA-3002 has no irritating activity when injected through subcutaneous or intramuscular route for clinical practice as 0.16% solution.

• Journal of Embryo Transfer
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• v.13 no.3
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• pp.207-212
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• 1998

This study was conducted to determined if single subcutaneous (s.c.) injection of Folltropin-V dissolved in polyethyleneglycol (PEG) can replace as the standard multiple intramuscular (i.m.) injection. The results suggest that the s.c. treatment produced more corpora lutea, embryos recovered and transferable embryos as compared to the i.m. treatment (p<0.05). This study indicates that a single s.c. injection of Folltropin-V dissolved in PEG was effective for superovulatory response and embryo yield in Korean cattle.

• Clinical and Experimental Pediatrics
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• v.56 no.3
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• pp.116-124
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• 2013

Purpose: Tumor necrosis factor (TNF)-${\alpha}$ is thought to contribute to pulmonary hypertension. We aimed to investigate the effect of infliximab (TNF-${\alpha}$ antagonist) treatment on pathologic findings and gene expression in a monocrotaline-induced pulmonary hypertension rat model. Methods: Six-week-old male Sprague-Dawley rats were allocated to 3 groups: control (C), single subcutaneous injection of normal saline (0.1 mL/kg); monocrotaline (M), single subcutaneous injection of monocrotaline (60 mg/kg); and monocrotaline + infliximab (M+I), single subcutaneous injection of monocrotaline plus single subcutaneous injection of infliximab (5 mg/kg). The rats were sacrificed after 1, 5, 7, 14, or 28 days. We examined changes in pathology and gene expression levels of TNF-${\alpha}$, endothelin-1 (ET-1), endothelin receptor A (ERA), endothelial nitric oxide synthase (eNOS), matrix metalloproteinase (MMP) 2, and tissue inhibitor of matrix metalloproteinase (TIMP). Results: The increase in medial wall thickness of the pulmonary arteriole in the M+I group was significantly lower than that in the M group on day 7 after infliximab treatment (P<0.05). The number of intraacinar muscular arteries in the M+I group was lower than that in the M group on days 14 and 28 (P<0.05). Expression levels of TNF-${\alpha}$, ET-1, ERA, and MMP2 were significantly lower in the M+I group than in the M group on day 5, whereas eNOS and TIMP expressions were late in the M group (day 28). Conclusion: Infliximab administration induced early changes in pathological findings and expression levels of TNF-${\alpha}$, and MMP2 in a monocrotaline-induced pulmonary hypertension rat model.

• Biomolecules & Therapeutics
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• v.2 no.3
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• pp.247-255
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• 1994

As a series of safety studies of DA-3030, a new rhO-CSF, its local irritancy was examined in the rabbits after the following treatment; application into the conjunctival sac of the eye(single), subcutaneous injection(single), intramuscular injection(single), and intravenous injection(8-day repeated). In addition, paravenous irritation of DA-3030 was investigated in mice. The results obtained were as follows. 1. In the result of ocular irritation test, 0.03% solution of DA-3030 could be considered as a non-irritating material. 2. The local irritation of DA-3030 by an injection of 0.5mι of its solution subcutaneously or intramuscularly was negligible and not so much different from that of saline. 3. In the vascular irritancy test, macro- and microscopic observations revealed that the irritating activity of DA-3030 in blood vessels was not different from that of saline when they were injected once a day into vein retroauricularis of rabbits for 8 days.4. The paravenous administration of DA-3030 did not induce any abnormal changes at injection sites except mild swelling in 1 mouse at 3 hours after injection which was thought to be due to slow absorption. The above-mentioned results suggest that DA-3030 has no irritating activity when injected through intravenous or subcutaneous route for clinical practice as 0.03% solution.

• Biomolecules & Therapeutics
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• v.1 no.2
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• pp.280-283
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• 1993

Single subcutaneous injection to SD rats of both sexes was performed to investigate the acute toxicity of new skin allergy-remedy ointment, Banaron. Banaron is composed of lidocaine hydrochloride, chloro-pheniramine maleate, prednisolone acetate, chlorohexidine hydrochloride, methyl salicylate, 1-menthol and d-camphor. The results were as fellows. $LD_{50}$, /TEX> values of Banaron were 8373.6 mg/kg for male and 8260.1 mg/kg for females. Death occurred within 24 hours after administration at doses up to 6600 mg/kg. The main cause of deaths seemed to be respiratory disturbance. General symptoms decreased of activity and respiratory rate, salivation, tremor and loss of consciousness which were commonly observed by some survived animals and all dead animals. No significant gross findings of internal organs and body weight changes in treatment groups in comparison with these of control group were observed at the maximum dose levels in Banaron.

• Journal of Veterinary Clinics
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• v.35 no.6
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• pp.299-301
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• 2018

A 7-year-old intact female Shih-Tzu with chylothorax was presented. Percutaneous popliteal computed tomographic lymphangiography was performed to evaluate the thoracic duct and seek any potential cause of chylothorax. Despite two attempts, visualization of the thoracic duct failed and perianal subcutaneous computed tomographic lymphangiography with injection of iodinated, nonionic water-soluble contrast medium (0.6 ml/kg) was performed. A single branch of intact thoracic duct and dilated and tortuous lymphatics were detected. It was diagnosed as idiopathic chylothorax. Perianal subcutaneous lymphangiography is considered a less-invasive, easy and reliable method to visualize lymphatics in patients with chylothorax.

• Toxicological Research
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• v.14 no.3
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• pp.393-400
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• 1998

As a series of safety studies on DA-3585, a recombinant human erythropoietin, its local irritancy was examined in rabbits after the following treatments; application into the conjunctival sac of the eye(single), subcutaneous injection (single and -day repeated)and intravenous injection (7-day repeated.)In addition, perivascular irritation of DA-3585 was investigated in mice. In the result of ocular irritation test, 10,000IU/ml solution of DA-3585 could be considered as a non-irritating material. The local irritation of DA-3585 by a single and 7-day repeated subcutaneous injection was negligible and not so much different from that of saline. In the vascular irritancy test, macro-and microscopic observations revealed that local irritation of DA-3585 was comparable to that of saline when injected into retroauricular vein of rabbits for 7 consecutive days. Furthermore the perivascular administration of DA-3585 upto the concentration of 10,000 IU/ml did not induce any morphological abnormalities at injection sites. The results obtained from the present study suggest that the local irritancy of DA-3585 is not different from that of saline when injected through intravenous or subcutaneous route for clinical practice.

• Biomolecules & Therapeutics
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• v.4 no.4
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• pp.411-414
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• 1996

Single subcutaneous administration to S.D rats of both sexes was performed to investigate the acute toxicity of Syndella gel, a new topical drug containing deproteinised dialysate of calf's blood and micronomicin sulfate. $LD_{50}$ values for S. D rats were 23,047 mg/kg for male and 23,725 mg/kg for female. The death occurred within 24 hours after administration at doses over 19,200 mg/kg. The main cause of death seemed to be respiratory disturbance by acute shock. Major general symptoms induced by injection subcutaneously with Syndella gel were underactivity, decreased respiratory rate, salivation, tremor and loss of consciousness. No significant body weight changes and gross findings of internal organs in treatment groups in comparison with those of control groups was observed at any dose levels in Syndella gel.

• Journal of Veterinary Science
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• v.22 no.5
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• pp.47.1-47.10
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• 2021

Background: Due to multiple similarities in the structure and physiology of human and pig skin, the pig model is extremely useful for biological drug testing after subcutaneous administration. Knowledge of the differences between subcutaneous injection sites could have a significant impact on the absorption phase and pharmacokinetic profiles of biological drugs. Objectives: This study aimed to analyze the impact of administration site on pharmacokinetics and selected biochemical and hematological parameters after a single subcutaneous administration of ustekinumab in pigs. Drug concentrations in blood plasma were analyzed by enzyme-linked immunosorbent assay. Pharmacokinetic analyses were performed based on raw data using Phoenix WinNonlin 8.1 software and ThothPro v 4.1. Methods: The study included 12 healthy, female, large white piglets. Each group received a single dose of ustekinumab given as a 1 mg/kg subcutaneous injection into the internal part of the inguinal fold or the external part of the inguinal fold. Results: The differences in absorption rate between the internal and external parts of the inguinal fold were not significant. However, the time of maximal concentration, clearance, area under the curve calculated between zero and mean residence time and mean residence time between groups were substantially different (p > 0.05). The relative bioavailability after administration of ustekinumab into the external part of the inguinal fold was 40.36% lower than after administration of ustekinumab into the internal part of the inguinal fold. Conclusions: Healthy breeding pigs are a relevant model to study the pharmacokinetic profile of subcutaneously administered ustekinumab.