In Vivo Toxicology Studies

In Vivo Toxicology Studies

Safety assessment as the gold standard before clinical advancement.

Safety assessment as the gold standard before clinical advancement.

Why in vivo toxicology

Preclinical safety assessment ensures drug candidates are safe before clinical trials. It evaluates organ-specific side effects, hematological changes, and helps estimate the therapeutic window—the margin between effective dose and toxic dose. Robust rodent models provide reproducible, literature-backed data and only require small compound amounts.

Preclinical safety assessment ensures drug candidates are safe before clinical trials. It evaluates organ-specific side effects, hematological changes, and helps estimate the therapeutic window—the margin between effective dose and toxic dose. Robust rodent models provide reproducible, literature-backed data and only require small compound amounts.

Preclinical safety assessment ensures drug candidates are safe before clinical trials. It evaluates organ-specific side effects, hematological changes, and helps estimate the therapeutic window—the margin between effective dose and toxic dose. Robust rodent models provide reproducible, literature-backed data and only require small compound amounts.

Rodent model strength.

Yields robust, reproducible outcomes and references across literature; low compound requirements.

Chemistry

Clinical Chemistry

Clinical Chemistry

Blood

Blood Cell Counts

Blood Cell Counts

Histology

Histology

Histology

LC-MS Bioanalytics

LC-MS Bioanalytics

Macroscopic Monitoring

Macroscopic Monitoring

End-to-End Expertise

End-to-End Expertise

Custom Study Design

Custom Study Design

Example Study: p38 Inhibitor Tolerability

Goal: Dose ranging in mice to estimate NOAEL, define target organs, and gauge the therapeutic index for p38 inhibitors CSY2159 and CSY2163 via repeated dosing.

Case Study Methods

15 C57BL/6 male mice (3 groups × 5), aged 7–8 weeks. Dosing: daily p.o. (vehicle, 50 mg/kg CSY2159, 50 mg/kg CSY2163) for 14 days; tail-vein bleeds on days 7 & 14; terminal sacrifice for hematology, clinical chemistry, and LC-MS organ analysis.

Key Results & Figures

Figure 1: Body weight trend shows stable tolerability. Figure 2: Hematology on day 14 confirms absence of cytopenias. Figure 3: Clinical chemistry (AST, ALT, creatinine, urea) within reference ranges. Figure 4: CSY2159 tissue concentrations—prodrug improves delivery to liver and eye. [Figure placeholders: left—image, right—caption/interpretation.]

Conclusion

Both CSY2159 and CSY2163 were well tolerated at 50 mg/kg p.o. for 14 days (>10× effective dose), supporting a broad therapeutic window for this substance class.

Planning a tox study?

Planning a tox study?

Contact Synovo for expert preclinical assessment.

Contact Synovo for expert preclinical assessment.

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