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Discovery Toxicity study |
Targeted organ discovery for toxicity study |
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Mechanisms of toxicity study |
Toxicity test that can help understand the mechanism pf identified toxicity |
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Genotoxicity study |
Comet assay and result analysis methodology |
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Cardiovascular toxicity study |
Test methodology of cardiovascular toxicity in Beagle dogs telemetry system |
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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 |
Simultaneously perform DRF, target toxicity exploration, PK/PD, cardiovascular toxicity evaluation, and comet assay tests in rodent/dog models |
Service
- Combined exploratory toxicity study provides effective non-clinical test
- Toxic analysis services that can be used for Go/No-go decisions through preliminary safety assessments at the GLP level.
- Examination of potential genetic toxicity via Comet assay
- Examination of potential cardiovascular toxicity via telemetry system
- Schirmer’s test, fundus camera, OCT (Ocular Coherence Tomography) for ocular toxicity evaluation service in rabbit, canine, swine, and primate models
- IHC of animal organs and human tissue to identify on-target/off-target antigen-binding site via antibody-drug conjugate and drug cross-reactivity
- Seeking broader judgments about toxic human resistance through investigative toxicology.
Combined exploratory toxicity study of
developed drugs in rodents
Histopathological finding
(Cholestasis, dog, liver, H&E, x400)
Service example ( Rodent Toxicity Assessment)
- Combined exploratory toxicity study of developed drugs in rodents
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Exam Overview |
- To determine the toxicity test dose, DRF (Dose Range Finding) test was performed to confirm the dose range of the developed drug in ICR mice. |
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Test contents |
- Capacity set to 60mpk, 180mpk, 540mp based on DRF test results - Conduct a 2-week repeated administration toxicity test in ICR mice at the set dose. - Liver and bone marrow tissues are collected during autopsy and in vivo Comet assay is performed together. - Perform histopathological examination to identify target organs |
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Result |
- When administered at high doses, weight loss and loss of energy appear. 
Liver, control 
Liver, treated - Comet assay results showed suspected genotoxicity. |
Service example ( beagle dog toxicity evaluation)
- Combined exploratory toxicity study of developed drugs using beagle dogs
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Exam Overview |
- Perform a dose escalating study and perform a repeated administration toxicity test with the set dose. |
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Test contents |
- A dose escalating study was conducted on one female and one male beagle dog each, and reflecting the results, the dose for the repeated administration test was set to 400 mg/kg. - Repeated administration toxicity test was performed for 2 weeks in beagle dogs at the set dose. - During the study period, telemetry was measured at the start of administration, one week after administration, and the last administration day to evaluate body weight and clinical symptoms and evaluate cardiovascular toxicity. - Perform hematological tests and serum biochemical tests through blood collection, and perform toxicokinetic (TK) analysis. |
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Result |
- As a result of histopathological examination, lesions caused by the administered substance were observed in the liver, kidney, lung, and small intestine. - As a result of the comet assay, no DNA damage caused by the drug was observed. - As a result of analysis of telemetry records, no cardiovascular toxicity was observed. - The maximum tolerated dose (MTD) upon administration is judged to be less than 400 mg/kg. 
Results of performing serum biochemical tests 
Histopathological findings (Cholestasis, dog, liver, H&E, x 400) |