Toxicology Services
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WuXi AppTec's established, clinically relevant testing models are designed to evaluate new routes of administration and exposure, new drugs, new materials, and altered material + drug performance.
Experience
- Over a decade of experience performing both toxicology and biocompatibility studies in support of combination product submissions to the FDA and other regulatory agencies.
- More than two dozen different companies have contracted with WuXi AppTec for combination product toxicology studies.
- Multiple products have already received regulatory approval.
Program Features
- Testing is custom designed with sponsor to take into account device + drug implications.
- Program results can meet ISO/FDA requirements and have been internationally accepted.
- Senior staff have extensive experience in medical device tissue responses and toxicology.
- Toxicology team includes Ph. D. toxicologists, board-certified pathologists and Ph.D. materials scientists.
- Drug/Device models include: Acute, Repeat, pK/tK and Toxicology Implant studies.
- Regulatory and consulting services available to support sponsors.