General Toxicology

General Toxicology Studies 

WuXi AppTec provides a full suite of GLP and non-GLP general toxicology studies and services, supported by the complementary capabilities of our DMPK, bioanalytical and analytical service teams. This cross-functional knowledge provides not only the data you need, but the insights into how that data relates to your project goals.

Your Expert Toxicology Partner

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 can accommodate GLP studies of varying size, length and complexity, and provide for overall regulatory compliance. We can also customize a toxicology study to meet your specific needs. Your studies will be conducted in our state-of-the-art facility comprising environmentally controlled animal rooms and supporting workspace.

Square Feet of Lab Testing Space

Environmentally Controlled Animal Rooms

Safety Assessment Studies Conducted/Year

IND-Enabling Toxicology Studies

For Preclinical Candidates (PCCs) or INDs, we provide bioanalytical method development and validation services in support of 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

We offer end-to-end testing programs that cover all your toxicology needs. This includes early-stage dose range finding studies that inform later-stage regulatory needs; single dose acute toxicity testing to identify potential adverse effects of new drug candidates; and repeat-dose chronic toxicity studies for evaluating the effects of repeat administration over a defined period of time.
 

  • 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

  • Mice
  • Rats
  • Canines
  • Cynomolgus and Rhesus Non-Human Primate (NHP)
  • Swine
  • Rabbits

 Routes of Administration

  • Intravenous (bolus, infusion)
  • Oral (gavage, capsule) and nasogastric (for NHPs)
  • Topical
  • Intramuscular
  • Subcutaneous
  • Intradermal
  • Ocular (including systemic, topical, subconjunctival, intravitreal, sub-retinal and retrobulbar)
  • Implant
  • Other (upon request)
    • Intrathecal
    • Intra-articular
    • intraperitoneal
    • Intra-arterial

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)
  • Immunopathology

General Toxicology FAQs

What are dose range finding studies?

Dose range finding studies provide the first stage of toxicology assessments to select the proper doses for later regulatory studies. The studies are then used to determine doses for longer team studies to assess risks.

What is single dose acute toxicity?

Single dose toxicity testing is used to determine potential adverse effects of new drug candidates and provide data for exposure. The data collected during these studies is used to design the dose levels for later repeat-dose, subchronic, and chronic toxicity studies.

What is repeat-dose chronic toxicity?

The objective of repeat-dose toxicity studies is to evaluate adverse effects of compounds when administered repeatedly for a specific period. The length of a repeat-dose study can be 14 days, subchronic up to 3 months, or chronic longer than 3 months up to 2 years.