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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 provides a full suite of these GLP and non-GLP studies and services, supported by the complementary capabilities of our DMPK, bioanalytical and analytical service teams. This cross-functional knowledge means you’ll not only receive the data you need, but insights into how that data relates to your project goals, as well.
As our client, we’ll customize a study to meet your specific needs. We can accommodate GLP studies of varying size, length and complexity, and provide for overall regulatory compliance. Your studies will be conducted in our state-of-the-art, 580,000 square foot facility comprising approximately 256 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 GLP toxicology studies that ensure a comprehensive safety assessment.
If you have early stage compounds, we recommend our Early Diagnosis Tests (EDT). These reduce the risks and costs associated with preclinical safety evaluations by detecting and eliminating potentially toxic drug candidates as early as possible. We can also help you save time in the drug development life cycle 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
- Formulation analysis and bioanalysis (GLP and non-GLP)
- Early Diagnosis Testing (EDT)
- Dose ranging or MTD
- Single dose (acute toxicity)
- Repeat dose (subacute, subchronic and chronic)
- Cynomolgus and Rhesus Non-Human Primate (NHP)
Routes of Administration
- Intravenous (bolus, infusion)
- Oral (gavage, capsule) and nasogastric (for NHPs)
- Ocular (including systemic, topical, subconjunctival, intravitreal, sub-retinal and retrobulbar)
- Other (upon request)
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)