Preclinical Development

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