Nonclinical GLP Toxicology Studies

Successful toxicology studies demand the contributions of skilled study directors, toxicologists, pathologists, veterinarians, surgeons, regulatory specialists and support personnel. With a strong mechanistic understanding of toxicology, our team can efficiently determine potential risk factors early in the drug development or agrochemical registration process. Many of our scientists have served on or are currently participating in regulatory and industry body working groups, shaping the future of our studies. Because we are on the front lines, we ensure that our products, services, and processes keep pace with the rapid evolution of science, technology and the ever-changing needs of your product development.

New SEND Guidance Notice:

As of July 15, 2020, the Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER) has released a Federal Register Notice announcing the requirement of support of CDISC Standard for the Exchange of Nonclinical Data (SEND). Learn More


Investigational New Drug Development Programs eGuide

Toxicologist working in a lab.

Need a custom solution? Our team is ready to develop a nonclinical development program just for you. Explore our regulatory toxicology services.

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Do you have the toxicology services necessary to move my project forward? Simply, Yes.

Your drug development needs are unique and customized preclinical programs are the new normal. Our experts have more than just general toxicology knowledge, explore all the specialty toxicology services available to you.

Blog: How predictive toxicology is influencing regulatory approaches

Your IND-enabling studies will help you submit your IND application to the FDA to move into clinical trials. The drug development process can be simplified with Charles River executing pharmaceutical and biotechnology companies’ IND programs.

New non-animal models and a weight of evidence approach could reduce the amount of animal testing required by regulators

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Frequently Asked Questions (FAQs) for Toxicology Studies

  • What are nonclinical toxicology studies?

    Nonclinical toxicology studies are conducted to determine the degree and severity of toxicity of a test item or compound in animals. The goal of these regulatory toxicology studies is to determine and assess the relationship between the various dose levels administered and adverse effects, as well as to determine any potential target organs or functions affected. If possible, the mode of toxic action may also be identified.

  • How do toxicology services support drug development?

    The data generated are evaluated in order to scientifically extrapolate potential effects in humans. The evaluation of risk relative to human safety is assessed not only by the degree and type of toxicity, but also by potential reversibility or irreversibility of effects. For studies supporting the development of human therapeutics, the scientific interpretation of these data is used to select, the most appropriate dose levels for utilization in human clinical trials.

  • How do toxicologists help drug developers identify risks earlier in development?

    Nonclinical study results provide data that are used to identify, evaluate, and manage risk. This is achieved by designing and conducting studies that maximize data assessment to identify areas of concern in the toxicity profile. This allows for reasonable extrapolation to humans (risk versus benefit). When areas of concern are identified, additional studies or investigations may be needed prior to the first administration to humans, or to register a new chemical substance or agrochemical active entity.