Capabilities

PHASE 0 & I STUDY EXPERIENCE INCLUDE:

  • First-in-Human (FIM)
    • Single Ascending Dose (SAD)
    • Multiple Ascending Dose (MAD)
    • Adaptive/Accelerated Protocols
  • PK, PD, BD
  • Food Effect
  • Drug/Drug Interaction
  • Age & Gender
  • Special Populations with specific diseases
    • (CHF, CRF, Malignancies etc.)
  • Bioavailability/Bioequivalence (For Biosimilar or Generic Version)

PHASE I/II STUDIES: NHCR will help the sponsor to combine Phase I and Phase II for:

  • Efficacy (response to new treatment)
  • Toxicity (safety, dosage levels)