Phase 1

  • First time in Man Safety / Tolerance
  • Bioavailability / Bioequivalence
  • Pharmacokinetics / Pharmacodynamics
  • Dose Response
  • Food effect Studies
  • IV Infusion Studies
  • Age/Gender
  • Drug Interactions
  • Metabolic Balance
  • Special Populations (Healthy, Renal, Hepatic, Diabetic, Post-Menopausal, Testosterone
  • Deficiency, Elderly, Obesity)