Early Phase Studies
- Phase I-II Proof-of-Concept [POC]
- Adaptive design studies: healthy volunteer and patient studies
- First in Human [FIH]
- Single Ascending Dose [SAD]
- Multiple Ascending Dose [MAD]
- Bioavailabilty/Bioequivalence [BA/BE]
- Pharmacokinetics/Pharmacodynamics [PK/PD]
- Dose ranging and Tolerability studies
- Food Effect studies
- Drug-Drug interaction studies
The main focus of CRU currently in Phase I studies are the hepatic impairment and renal impairment studies. CRU is the worldwide best enroller in these indications as:
- There are a well organised, unique governmental center registry and medical documentation system
- Renal and hepatic impaired patients are treated in dedicated centers, hospitals, so the patient flow is well managed via refering hospitals and physicians
- The incidence of both indications are very high in Hungary due to cultural, social, genetic and medical reasons
