• Expert scientific review and evaluation of new development concepts and projects.
  • Consultation regarding regulatory requirements, study designs and preclinical development plans.
  • Design and conduct preclinical studies for:
    • In vitro and in vivo safety and efficacy
    • Dose, schedule, route of administration and formulation optimization
    • Single-dose, repeat-dose and GLP toxicology
    • General and safety pharmacology
    • Pharmacokinetics and toxicokinetics
  • Support for FDA meetings and filings; IND and IDE development and submission.
  • Coordinate development activities such as bioanalytical method development; stability testing; and pilot, scale-up, and GMP manufacturing of clinical product.
  • Support for Phase I clinical trial design and implementation.

The Center for Translational Medicine provides no-cost consultations and offers a wide range of expert, high-quality, cost-effective preclinical development services. Laboratory services are provided to internal and external clients on a fee-for-service basis.

Studies are designed, conducted and reported in compliance with SOPs, IACUC and regulatory requirements.