FCRL conducts Phase I studies with NCEs to assess safety and tolerability, to evaluate pharmacokinetic and pharmacodynamic parameters, and to explore drug-drug and food-drug interactions.
Infrastructure
Hospital-based Clinical Pharmacology Unit
Access to Intensive Care Unit of Hospital
Access-controlled Pharmacy, Archives and Server room
Dedicated sample processing laboratories
LCMS-based bioanalytics
Pharmacokinetic analysis using WinNonlin
Statistical analysis using SAS
Access to Independent Ethics Committees
Database of healthy male, female and post-menopausal female volunteers
Team
Medical Writers
Clinical Research Physicians with experience in Phase I studies
