Clinical Phase I
|
During Phase I we want to clarify:
- How does the drug move and get to the correct target in the body?
- What doses a person can take and what effects are expected?
- For how long the drug effects and how it is metabolized and excreted from the body?
|
The first Phase I studies are intended to confirm the drug dosage levels that can be safely applied in the following, scientifically more valid clinical study Phases. The fate of drugs and their products of metabolism can be determined in Phase I clinical studies, and the initial evidence of the drug efficacy may be obtained. Usually, Phase I studies involve a range from twenty to eighty study subjects.
 |
In phase I studies where the investigational drug is for the first time introduced into humans, ascending doses of the drug are sequentially administered, starting from a very low dose level, under rigorous safety monitoring. When the drug is shown to be safe and well-tolerated, the clinical development program can proceed to Phase II studies. Phase I –like studies are needed also during the later clinical development Phases.
Phase I interaction studies, performed between the investigational drug and other drugs or food, are often carried out simultaneously with Phase II-IV clinical studies.
At Orion, phase I studies are on-going with the Central Nervous System medicines. |
Updated
Dec 17th 2010