Clinical Phase II
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In Phase II we want to clarify:
- How does the medicine effect in the illness?
- Are the expected signs of efficacy seen in patients?
- Which doses are needed to get the desired effect without adverse effects?
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In the clinical Phase II-studies the medicine is given to patients and its effects in the illness are investigated (Proof-of-concept) and the effective doses are selected. In the studies carried out with dozens of patients in clinics and hospitals, the aim is to further confirm the effects of the medication in the body and to get hints of efficacy. During the studies a lot of information is gained to plan adequate Phase III trials with proper design. The duration of Phase II depends on the indication and on how quickly the effect of the medicine can be seen and measured.
Orion has Phase II studies on-going in hospitals and clinics around Europe. Phase II studies are on-going with Easyhaler and Animal Health medications.
Updated
Dec 17th 2010