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Discovery Toxicity study |
Target Organ Toxicity Evaluation |
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Mechanistic toxicity study |
Study of how chemical or physical agents interact with living organisms to cause toxicity |
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Genotoxicity study |
Comet assay and result analysis methodology |
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Cardiovascular toxicity study |
Assessment of telemetry systems in beagle dogs |
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Tissue Cross Reactivity (TCR) study |
Evaluation by IHC in laboratory animals and human tissues |
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Combined exploratory toxicity study |
Simultaneous DRF, target toxicity exploration, PK/PD, cardiovascular toxicity evaluation, and comet assay in Rodent/Dog Models |
Service
- Conduct non-clinical studies through combined exploratory toxicity studies.
- Provide toxicity interpretation services for Go/No-Go decision-making based on GLP-level preliminary safety evaluation.
- Assess potential genotoxicity through the Comet assay.
- Evaluate potential cardiovascular toxicity using a telemetry system.
- Perform ocular toxicity assessments using techniques such as Schirmer’s test, fundus camera, and OCT (Optical Coherence Tomography) across rodent to primate models.
- Identify cross-reactivity of antibody-drugs and determine On-target/Off-target antigen binding sites in tissues from both laboratory animals and humans using immunohistochemistry (IHC)
- Pursue broader assessments of the human relevance of toxicity through investigative toxicology.
Combined exploratory toxicity
study in rodents
Histopathological finding
(Cholestasis, dog, liver, H&E, x400)
Service example ( Rodent Toxicity Assessment)
- Combined exploratory toxicity study in rodents for drug development
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Overview |
A Dose Range Finding (DRF) study was conducted in ICR mice to determine the dose range of the investigational drug for toxicity testing. |
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Design |
- Based on the DRF study results, doses of 60 mpk, 180 mpk, and 540 mpk were established. - A 2-week repeat-dose toxicity study was conducted in ICR mice using the established doses. - During necropsy, liver and bone marrow tissues were collected, and an in vivo Comet assay was performed. - Histopathological examination was conducted to assess target organs. |
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Result |
- At high doses, weight loss and signs of decreased vitality were observed. 
Liver, control 
Liver, treated Comet assay results show potential genotoxicity |
Service example ( beagle dog toxicity evaluation)
- Combined exploratory toxicity study in beagle dogs for drug development
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Overview |
Performing a dose-escalating study and conducting repeated-dose toxicity testing at the established doses |
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Design |
- A dose-escalating study was conducted in one female and one male beagle dog, and based on the results, the dose for the repeated-dose toxicity study was set to 400 mg/kg. - A repeated-dose toxicity study was conducted in beagle dogs for a 2 week using the established dose. - Body weight and clinical symptoms were evaluated during the study period, and telemetry measurements were taken on the date of first dose, one week after dosing, and on the last dosing day to assess cardiovascular toxicity. - Hematological and serum biochemical tests were performed through blood collection, and toxicokinetic (TK) analysis was conducted. |
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Result |
- Organ histopathological examination results: Lesions caused by the drug were observed in the liver, kidneys, lungs, and small intestine. - Comet assay results: No DNA damage caused by the drug was observed. - Telemetry analysis: No cardiovascular toxicity was observed. - Maximum Tolerated Dose (MTD): The MTD is determined to be 400 mg/kg or less. 
Results of performing serum biochemical tests 
Histopathological findings (Cholestasis, dog, liver, H&E, x 400) |