Toxicology & safety assessment

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.