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Discovery Toxicology
ANEWCRO offers a comprehensive suite of preclinical toxicology assessments designed to evaluate the safety, tolerability, and pharmacological effects of investigational compounds, medical devices, and novel therapies. Our expertise spans dose-range finding (DRF) studies, maximum tolerated dose (MTD) evaluations, and general toxicology assessments, all of which play a critical role in early-stage drug development.
Dose-range finding (DRF) studies are essential for determining the appropriate dosing regimen for subsequent toxicology and efficacy studies. These studies involve administering a compound across a range of doses to evaluate its pharmacokinetic (PK) profile, initial signs of toxicity, and overall tolerability. DRF studies provide foundational data that guide dose selection for long-term safety evaluations, ensuring that subsequent studies are conducted within safe and effective dosing parameters.
Maximum tolerated dose (MTD) studies are conducted to identify the highest dose of a test article that can be administered without causing severe toxicity or life-threatening adverse effects. By incrementally increasing doses and monitoring subjects for physiological and biochemical responses, MTD studies help define the upper limits of drug exposure while maintaining animal welfare. This information is crucial for establishing safe dose ranges in human clinical trials.
General toxicology assessments encompass a broad range of evaluations designed to characterize the systemic effects of a compound over short-term (acute) and long-term (chronic) exposure periods. These studies assess potential toxic effects across multiple organ systems, including the liver, kidneys, cardiovascular system, respiratory system, and central nervous system. Endpoints commonly evaluated in general toxicology studies include clinical observations, body weight changes, hematology, clinical chemistry, histopathology, and organ weight analyses.
In addition to evaluating small-molecule drugs, biologics, and gene therapies, ANEWCRO’s toxicology capabilities extend to **medical device safety assessments**. These studies assess biocompatibility, local tissue reactions, systemic toxicity, and potential long-term complications associated with implanted or externally applied medical devices. Our team employs validated methodologies in accordance with regulatory guidelines to ensure robust safety evaluations.
These early-stage toxicology studies are instrumental in candidate selection for future preclinical development. By identifying compounds with acceptable safety margins and eliminating those with significant toxic liabilities, DRF, MTD, and general toxicology studies streamline the drug development pipeline. This process not only reduces the risk of late-stage failures but also optimizes resource allocation by focusing on the most promising candidates for further development.
By leveraging our expertise in toxicology assessments, ANEWCRO helps researchers and pharmaceutical sponsors make informed decisions early in the drug development process, reducing risks and accelerating the path to clinical trials.