Preclinical Toxicology Studies in IBD Drug Development

Preclinical toxicology studies are critical to the drug development process. Preclinical toxicity tests in a variety of biological systems reveal the toxic effects of new compounds on species, organs and doses. They help to assess the potential safety and toxicity of drug candidates before they are tested in human clinical trials and provide the basis for regulatory approval.

Our Toxicology Testing Services

Ace Therapeutics offers a full suite of GLP and non-GLP toxicology studies and services for our clients' IBD drug development programs. In addition, our DMPK and bioanalytical services team provides complementary capabilities for support. This cross-functional knowledge provides not only the data you need, but also insight into how that data relates to your program goals.

With a deep understanding of toxicology, our team can effectively identify potential risk factors early in the IBD drug development process. We offer end-to-end testing programs to meet all of your IBD drug toxicology testing needs.

Our toxicologytesting portfolio includes:

• Acute and sub-chronic toxicology
• Chronic toxicology
• Reproductive and developmental toxicology
• Safety pharmacology
• Genetic toxicology
• Carcinogenicity
• Ocular toxicology
• Skin toxicology
• Musculoskeletal toxicology
• Neurotoxicology
• In vitro toxicology
• Ototoxicity testing
• Phototoxicity testing
• Toxicokinetics and ADME
• Mode of action
• Pathogenicity/infectivity studies

Our Capabilities in Toxicological Pathology

• We support preclinical studies to rapidly assess potential toxicity of IBD drugs
• Conducting hematology, chemistry, coagulation, and urinalysis using state-of-the-art instrumentation
• Necropsy (collection of protocol-specified animal tissues in non-clinical toxicology studies)
• Histopathology (collection of tissue and preservation in appropriate media, followed by trimming, embedding, sectioning, and special staining)
• Immunohistochemistry (IHC) and tissue cross-reactivity (TCR)
• Immunopathology

Ace Therapeutics' experienced safety assessment team comprehensively evaluates the safety of new therapeutic candidates for IBD. We can undertake toxicology studies of varying size and complexity and provide full regulatory compliance. We can also customize toxicology studies to meet your specific needs. If you are interested in our services, please do not hesitate to contact us.