Clinical Pharmacology

  • Design project clinical pharmacology plan based on latest FDA and ICH guidances
  • Design and execute CP studies, including protocol generation for:
    • PK/PD and dose identification
    • Thorough QTc/ECG
    • Food-effect
    • Drug-drug interactions
    • Pharmacogenetics (e.g., CYP P450 genotypes: EM, PM, UM)
    • Special patient populations (e.g., renal impairment, hepatic impairment)
  • Identification, selection and management of Phase I CRO’s
  • Serve as medical safety monitor for CP studies