Our toxicology services provide comprehensive, regulatory-compliant safety evaluation studies essential for Investigational New Drug (IND) applications. We specialize in conducting acute and chronic toxicity tests aligned with OECD guidelines to support drug development pipelines and regulatory submissions globally.
Acute Toxicity Testing
We conduct acute toxicity evaluations following OECD Test Guidelines 402, 403, and 404. These studies assess potential adverse effects after a single or short-term exposure via dermal (OECD 402), inhalation (OECD 403), or dermal irritation (OECD 404) routes. Our protocols measure clinical signs, mortality, and pathological changes to identify dose-related toxicity and guide safe human exposure levels.
Subchronic and Chronic Toxicity Studies
Our subchronic oral toxicity studies under OECD 408 evaluate systemic effects following repeated dosing over 90 days, providing essential data on target organ toxicity, dose-response relationships, and reversibility. For long-term exposure, our chronic toxicity services comply with OECD 452 guidelines, supporting assessment of prolonged toxic effects critical for safety margins in clinical trials.
Specialized Toxicity Evaluations
We offer carcinogenicity testing per OECD 453 to determine potential cancer-causing risks of investigational compounds through extended exposure. Toxicokinetic studies under OECD 417 provide detailed absorption, distribution, metabolism, and excretion (ADME) profiles, linking systemic exposure to observed toxicological outcomes.
Acute Toxicology and Dose Range Finding
Acute toxicity dose range finding studies conducted according to OECD 425 guide subsequent subchronic and chronic study dose selection. These investigations provide vital safety data for determining the maximum tolerated dose (MTD) and support dose optimization for IND studies.
Regulatory Compliance and Quality Assurance
All studies are performed in compliance with OECD Good Laboratory Practice (GLP) standards and international regulatory requirements. Our experienced toxicologists and pathologists ensure rigorous data collection, analysis, and reporting to facilitate smooth regulatory review and approval.