Clinical Pharmacology Studies
The concept of “Phases” in clinical drug development originates from the FDA, after WW2. Most clinical pharamcology studies are Phase 1 studies, when we learn about the PK of the drug. In Phase 2, we learn about the PD of the drug.
Phase 1 First in Human
- First in human (FIH) PK/PD
- Single ascending dose (SAD)
- Multiple ascending dose (MAD)
- Food effect (for oral drugs)
- Pharmacogenomics (CYP genotyping)
Phase 2
- Mass Balance/ADME
- Drug-drug interaction (DDI) in vivo
- QT study
- Dose identification
- Healthy vs Patient PK & PD
- Relevant special populations
- RI
- HI
- Pediatrics
- Elderly
- Pregnant
- Lactating
- Obese
- other
Phase 3
- Bioequivalence (BE), eg between formulations or drug combinations
- Exposure-efficacy/safety in target population