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Toxicology & safety assessment

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Toxicology studies

Toxicology studies are crucial in assessing drug safety, meeting regulatory requirements and informing clinical trial design. These studies help determine safe dosing, identify target organs for toxicity and predict potential risks to humans, while the data supports go/no-go decisions. Finding a trusted laboratory partner is essential to selecting animal model,   meeting regulatory requirements, interpreting complex data, managing costs and timelines, addressing alternatives to animal testing, integrating toxicology data, identifying safety issues early and balancing thorough assessment with accelerated development.

Why choose Labcorp?

  • 80+ years’ experience in general and specialty toxicology

  • Small and large animal models, all routes of administration, all modalities

  • 2,000+ toxicology studies initiated annually across our global footprint

Propel your development program with our comprehensive GLP toxicology solutions

Whether you're developing small molecules, biologics, cell and gene therapies or novel modalities, we tailor our approach to your compound and development goals and deliver clear, reliable data and insights. We offer a full spectrum of general and specialized toxicology studies across species, administration routes and therapeutic areas. From exploratory studies to GLP-compliant IND/CTA-enabling programs, our team works as an extension of yours to:

Identify potential safety signals early to reduce late-stage surprises

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Support regulatory submissions with high-quality, audit-ready data

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Align study designs with the specific needs of your compound and modality

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Navigate global regulatory expectations with confidence

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Drive informed, data-backed go/no-go decisions

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Toxicology & safety capabilities

Environmental risk assessment for pharmaceutical drugs

Assessing the possible environmental effects of a pharmaceutical product can take more than two years. When you need strategic solutions to accelerate product development, count on our dedicated environmental risk assessment (ERA) team.

Culture of Care label. Care: Clients, Animals, Research, Employees

Compassionate animal welfare – CARE

We are committed to the welfare of animals we work with in research. Our state-of-the-art European animal housing facilities and innovative animal welfare AI system help to deliver quality, effective late-stage studies.

New approach methods (NAMs) and in vitro alternatives

Achieve your goals ethically and sustainably using the newest methods, technologies and alternatives.

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Additional information

Ophthalmic development solutions

Advance your ophthalmic program with unmatched expertise in ocular safety assessment, pharmacology and DMPK.

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Inhalation toxicology

Explore case studies where our unique problem solving approaches saved time, money and resources.

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SEND datasets

Support the submission of nonclinical data to the FDA with SEND datasets provided by a global, experienced team who is active in the CDISC SEND Consortium and FDA/PHUSE Working Groups.

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Frequently asked questions

The main types include acute, subchronic and chronic toxicity studies, as well as specialized studies like reproductive toxicology and carcinogenicity. Labcorp conducts all these types of studies in compliance with GLP regulations.

Animal studies help predict potential toxicity in humans and are required for regulatory submissions. Labcorp has extensive experience in conducting animal toxicology studies across various species and routes of administration.

In vitro studies provide initial toxicity data and can help reduce animal testing. Labcorp offers a wide range of in vitro toxicology assays, including cell-based assays and organ-on-a-chip models.

Absorption, Distribution, Metabolism, Excretion (ADME) studies help understand how a substance moves through the body, which is crucial for assessing potential toxicity. Labcorp's integrated ADME and toxicology services provide a comprehensive view of a compound's safety profile.

Common endpoints include mortality, clinical signs, body weight changes, food consumption, clinical pathology and histopathology. Labcorp's toxicology studies cover all these endpoints and can include specialized assessments as needed.

Studies are designed based on regulatory guidelines, the type of substance being tested and the intended use. Labcorp's experienced toxicologists can help design studies that meet both regulatory requirements and specific research needs.

Proper dose selection is crucial for identifying toxic effects and establishing safety margins. Labcorp uses data from preliminary studies and PK/PD assessments to help select appropriate doses for definitive toxicology studies.

Toxicology studies provide critical safety data that inform decision-making throughout drug development, from lead optimization to clinical trials. Labcorp's integrated drug development services support clients from early discovery through regulatory submission.

From early discovery to regulatory submission and beyond, our nonclinical development solutions help derisk your program, accelerate timelines and optimize decision-making.