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.