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Preclinical toxicology assessment is required by regulatory authorities to establish the toxicological profiles of your new drug candidate prior to First-in-Human (FIH) studies. We can accommodate your GLP studies of varying size, length, complexity and overall regulatory compliance. Your studies will be conducted in our state of the art 580,000 square foot facility comprising approximately 256 animal rooms and supporting areas. Furthermore, to ensure we minimize any variables, all environmental factors are controlled and monitored following appropriate guidance and Standard Operating Procedures (SOPs).
Non-GLP and GLP toxicology services encompass the major majority of those studies required for safety assessment of potential therapeutics, and are supported by the complementary capabilities of our DMPK, bioanalytical and analytical service teams. The cross-functional knowledge and experience of our teams ensures prompt delivery of the data you need to inform you of your development efforts, as well as contextual insight into how that data relates to your project goals. Studies can be fully customized, as appropriate, to meet the specific needs of each project. Our focus is to provide scientific services that are applicable and relevant to the primary goals of a study.
IND-Enabling Toxicology Studies
For Preclinical Candidates (PCCs) or INDs, our bioanalytical method development and validation services support GLP toxicology studies for a comprehensive safety assessment. If you have early stage compounds, we recommend our Early Diagnosis Tests (EDT) to reduce the risks and costs associated with preclinical safety evaluations by detecting and eliminating potentially toxic drug candidates as early as possible. WuXi AppTec can assist you in reducing drug development life cycles by rapidly 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 each of 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 T-cell Receptor (TCR)