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General Toxicology

Non-GLP and GLP toxicology services at the Laboratory Testing Division span the entire spectrum of drug discovery and development, and are supported by the complementary capabilities of our DMPK, bioanalytical and analytical service units. The cross-functional knowledge and experience of our teams ensure prompt delivery of the data you need to inform your development efforts, as well as contextual insight into how that data relates to your project goals. Studies can be fully customized to meet the specific needs of each project.

IND-Enabling Toxicology Studies

For PCCs or INDs, our bioanalytical method development and validation services support GLP toxicology studies for a comprehensive safety assessment. For clients with 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.

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)

Species
+ Rodents
+ Canines
+ NHPs
+ Swine

Routes of Administration
+ Intravenous (bolus, infusion)
+ Oral (gavage, capsule) and nasogastric (for NHPs)
+ Intramuscular, subcutaneous, intradermal, intrathecal, intra-articular, intraperitoneal, intra-arterial
+ Ocular
+ Implant

In-House Pathology Capabilities
+ Clinical pathology (hematology, chemistry, coagulation and urinalysis)
+ ACVP board-certified pathologist
+ Necropsy (large capacity)
+ Histopathology by board-certified pathologists (trimming, embedding, sectioning, and special staining)

Type of Sample
+ Small molecules
+ Biologics
+ Natural products
+ Vaccines

NDA-Enabling Toxicology Studies

One of the benefits of working with an integrated, global platform like WuXi is the personalized, end-to-end support we are able to provide for each of our clients’ projects. For 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.

+ Chronic/subchronic tox
+ Carcinogenicity study (2-year rat/mouse, and 26-week rasH2 transgenic mice)
+ AE investigative-type studies