What kind of toxicology studies do I need for IND approval of my drug?
What biocompatibility studies are required for my medical device?
Can I predict human dosing from my xenograft studies?
Example of solutions to address the above questions
- Perform preclinical risk analyses
- Design preclinical programs or studies
- Assess device handling and evaluate performance (Human Factors Evaluations and User Requirement Testing)
- Produce or input to nonclinical and regulatory documents