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General Toxicology

WuXi AppTec provides a full suite of GLP and non-GLP general toxicology studies and services, supported by the complementary capabilities of our DMPK, bioanalytical and analytical service teams. This cross-functional knowledge provides not only the data you need, but the insights into how that data relates to your project goals.

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Square FT of Lab Testing Space

Environmentally Controlled Animal Rooms

Safety Assessment Studies Conducted/Year

Comprehensive General
Toxicology Testing from IND to NDA

As a required step prior to First-In-Human (FIH) studies, preclinical toxicology assessment is critical to the progression of your new drug candidate. WuXi AppTec can accommodate GLP studies of varying size, length and complexity, and provide for overall regulatory compliance. We can also customize a toxicology study to meet your specific needs. Your studies will be conducted in our state-of-the-art facility comprising environmentally controlled animal rooms and supporting workspace.

IND-Enabling Toxicology Studies

For Preclinical Candidates (PCCs) or INDs, we provide bioanalytical method development and validation services in support of GLP toxicology studies that ensure a comprehensive safety assessment. If you have early-stage compounds, we recommend our Early Diagnosis Tests (EDT) which detect and eliminate potentially toxic drug candidates early on, saving you critical time and costs. We can also reduce risk and costs by quickly screening libraries of candidate molecules, or by providing the unique PK/PD profile to assess the overall risk vs. benefit before moving forward.

NDA-Enabling Toxicology Studies

One of the benefits of working with an integrated, global platform like WuXi AppTec is the personalized, end-to-end support we are able to provide for all your projects. For New Drug Application (NDA) submissions in particular, we can leverage the knowledge gained from working with your compound from the early stages of preclinical research to provide the best chance of success as you move through the clinical phases of development to market.

General Toxicology Services

We offer end-to-end testing programs that cover all your toxicology needs. This includes early-stage dose range finding studies that inform later-stage regulatory needs; single dose acute toxicity testing to identify potential adverse effects of new drug candidates; and repeat-dose chronic toxicity studies for evaluating the effects of repeat administration over a defined period.

        Species

        • Mice
        • Rats
        • Canines
        • Cynomolgus and Rhesus Non-Human Primate (NHP)
        • Swine
        • Rabbits

         

        Routes of Administration

        • Intravenous (bolus, infusion)
        • Oral (gavage, capsule) and nasogastric (for NHPs)
        • Topical
        • Intramuscular
        • Subcutaneous
        • Intradermal
        • Ocular (including systemic, topical, subconjunctival, intravitreal, subretinal and retrobulbar)
        • Implant
        • Other (upon request)
        • Intrathecal
        • Intra-articular
        • intraperitoneal
        • Intra-arterial

        In-House Toxicologic Pathology Capabilities

        • Clinical pathology (hematology, chemistry, coagulation and urinalysis)
        • American College of Veterinary Pathologists (ACVP) and Chinese College of Veterinary Pathologist (CCVP) board-certified pathologists
        • Necropsy (large capacity)
        • Histopathology (trimming, embedding, sectioning and special staining)
        • Immunohistochemistry (IHC) and Tissue Cross Reactivity (TCR)
        • Immunopathology

        General Toxicology Reporting

        WuXi AppTec leverages an automated reporting system to draft reports and has a dedicated study director group for report checking and peer-reviewing. Our team is committed to provide high quality study data and deliver the reports timely in order to meet your timeline.

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        General Toxicology FAQ

        What types of general toxicology services do you offer?

        We offer a range of general toxicology services, including acute and chronic toxicity studies, dose-response assessments, genotoxicity evaluations, and organ-specific toxicity testing. Our services are designed to evaluate the safety and potential adverse effects of new compounds and products.

        How do you ensure the quality and reliability of your toxicology studies?

        We adhere to strict quality management practices and follow GLP (Good Laboratory Practice) guidelines to ensure the accuracy and reliability of our studies. Our experienced team conducts thorough validation and calibration of equipment, rigorous data analysis, and comprehensive reporting to maintain high standards.

        What animal models do you use in your toxicology studies?

        We utilize a variety of animal models, including rodents, rabbits, and non-human primates, depending on the study requirements and the nature of the compound being tested. Our choice of models is guided by regulatory standards and the specific needs of each study.

        How long does it take to complete a toxicology study?

        The timeline for completing a toxicology study varies based on the study’s complexity and scope. Typically, acute toxicity studies may take a few weeks, while chronic or long-term studies can span several months. We provide estimated timelines during the planning phase of each project.

        Can you support regulatory submissions with your toxicology data?

        Yes, we provide comprehensive toxicology data and reports that are tailored to meet regulatory requirements for submissions to agencies such as the FDA, EMA, and other global regulatory bodies. Our data supports the development and approval processes for new drugs and chemicals.

        How do you handle confidential information related to toxicology studies?

        We maintain strict confidentiality protocols to protect all sensitive and proprietary information. Access to study data is restricted to authorized personnel only, and we implement robust data security measures to safeguard your information throughout the study process.

        What is the process for initiating a toxicology study with your company?

        To initiate a toxicology study, you can contact us to discuss your specific needs and objectives. We will collaborate with you to create the study design, provide a detailed proposal, and finalize the project plan. Once the study is underway, we keep you informed with regular updates and progress reports.

        Are your toxicology services customizable to meet specific project needs?

        Yes, our toxicology services are highly customizable to address the unique requirements of each project. We work closely with clients to develop tailored study designs and protocols that align with their specific goals and regulatory requirements.

        What are dose range finding studies?

        Dose range finding studies provide the first stage of toxicology assessments to select the proper doses for later regulatory studies. The studies are then used to determine doses for longer team studies to assess risks.

        What is single dose acute toxicity?

        Single dose toxicity testing is used to determine potential adverse effects of new drug candidates and provide data for exposure. The data collected during these studies is used to design the dose levels for later repeat-dose, subchronic, and chronic toxicity studies.

        What is repeat-dose chronic toxicity?

        The objective of repeat-dose toxicity studies is to evaluate adverse effects of compounds when administered repeatedly for a specific period. The length of a repeat-dose study can be 14 days, subchronic up to 3 months, or chronic longer than 3 months up to 2 years.