Single-dose & Repeated Dose Toxicity Testing

Prisys Biotech provides comprehensive single-dose and repeated-dose toxicity testing services, essential for robust safety assessments during drug development. These studies are critical for informing key development decisions and mitigating risk prior to clinical trials. Our experienced team of toxicologists and clinicians collaborate closely to design and execute studies tailored to your specific needs.

Single-dose toxicity studies determine the adverse effects of a substance following a single administration. This crucial data helps establish the initial toxicity profile of a drug candidate and informs further study designs.

Repeated-dose toxicity studies assess the effects of a substance following multiple administrations over a specified period, typically ranging from 2 to 6 weeks. These studies are pivotal for evaluating the safety profile of a drug candidate, identifying potential target organ toxicities, and characterizing the reversibility of adverse effects.

Our team collaborates with drug development teams to determine the optimal study design for your specific compound. Considerations include:

• Species Selection: Choosing the most relevant species (non-rodent, or non-human primate) for your test article.
• Treatment Group Size: Determining the appropriate group size for statistical analysis and robust data.
• Duration of Treatment: Selecting an appropriate dosing period based on the intended clinical use and expected effects.
• Route of Administration: Choosing a relevant route that aligns with clinical application.
• In-life Observations: Monitoring animals for clinical signs of toxicity.
• Terminal Endpoints: Defining specific endpoints, including histopathology, clinical chemistry, and biomarker evaluation.
• Biomarker Identification: Identifying and assessing relevant translational biomarkers that can be used in clinical trials to minimize risk.

Prisys Biotech offers specialized endpoints based on the pharmacology of the test article. Our toxicology laboratory services provide comprehensive analysis, ensuring a complete understanding of the toxicological effects.

Prisys Biotech is committed to providing reliable and accurate single-dose and repeated-dose toxicity data to support your drug development program. Contact us to discuss how our services can help you meet your regulatory and safety requirements.

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