In Vivo Toxicity Assessment Services

We provide comprehensive in vivo toxicology services to rigorously evaluate the safety profiles of novel therapeutic candidates intended for the treatment of iron overload. Understanding the potential toxicity of the candidate is paramount in the drug development pipeline, ensuring patient safety and regulatory compliance. Our state-of-the-art facilities and experienced scientific team are equipped to conduct a wide array of studies to identify and characterize potential adverse effects.

Our service portfolio encompasses a diverse range of established animal models to assess various aspects of toxicity. These models include, but are not limited to:

Acute and Chronic Toxicity Studies

Rodent Models: We utilize multiple rat strains (e.g., Sprague Dawley, Wistar) and mouse strains (e.g., C57BL/6, HRN, generic Mus musculus) to investigate both acute (single-dose) and chronic (repeated-dose) systemic toxicity. Endpoints for these studies primarily include mortality, as well as a range of adverse event observations.

Non-Rodent Models: Studies in Caenorhabditis elegans (various strains including CB1370, DR1309, N2, RB2603, RB668, TJ1060) are available for initial acute toxicity screening, focusing on lethality as a primary outcome.

Primate Models: For higher-order translational relevance, we offer acute and chronic toxicity evaluations in non-human primates, including Macaca fascicularis (Cynomolgus monkey) and Callithrix jacchus (marmoset monkey), with death as a key endpoint. Specialized models, such as streptozotocin-induced pancreatic islet xenografts in Cynomolgus monkeys, are also available to assess toxicity in specific disease contexts.

Specific Organ and Systemic Toxicity Assessments

Hepatotoxicity: We offer assessments for anxiety (zebrafish, Sprague Dawley rat), sedation (Sprague Dawley rat), stereotypy (Sprague Dawley rat), and neuromuscular blockade (Rhesus monkey).

Metabolic Adverse Events: Studies to detect glucosuria are conducted in Sprague Dawley rats.

Drug Addiction Risk: Morphine-induced drug addiction potential can be evaluated in C57BL/6 mice.

Hyperactivity: Assessments for hyperactivity are available in Sprague Dawley rats.

By employing a comprehensive suite of in vivo models, we aim to provide a thorough characterization of the toxicological risks associated with your novel iron overload drug candidates. Our detailed reports will support critical decision-making throughout the preclinical development process, facilitating the progression of the safest and most efficacious compounds towards clinical investigation.