PHASE I UNITS

Phase 1 of a clinical trial is the first phase when a newly developed drug is administered to a human. In particular, this phase assesses whether the drug is safe and what its pharmacokinetic parameters are. The primary objective of Phase I is not yet to verify efficacy. The aim is to demonstrate that the drug substance under development cannot fundamentally harm anyone. This evaluation is most often carried out in healthy volunteers and is an absolutely crucial phase for the continuation of clinical research. The evaluation takes place under strictly controlled conditions and in specialised units with full medical support. These units allow early clinical trials to be conducted in full compliance with all legislative requirements, meeting Good Clinical Practice (ICH GCP) and international standards.