Clinical Phase III

 

During the Phase III we want to clarify:

  • Can we repeat the results we have seen with the medicine earlier on efficacy and safety in large patient groups?
  • Are the chosen doses effective and safe?

 

In the Phase III-studies the efficacy and safety of the medicine are confirmed with even thousands of patients in clinics and hospitals in several countries. The studies are blinded so that the patients, their doctors or the company representatives do not know which patient is getting the investigational medicine and who is getting placebo or the already marketed reference medicine.

Phase III is the largest and most expensive part of the development - the costs cover about two thirds of the whole development cost of a new proprietary product. The strategy of Orion is that in this Phase we work closely with our partners to share the costs and risks. After the Phase III studies, all the results obtained during development are compiled together and a marketing authorisation application is prepared.

 

After the marketing authorisation, often Phase IV-studies are carried out to continue collecting information on the medicine in the markets.

There are Phase III studies on-going with Orion products in about 20 countries in Europe and through partners also in other continents within Oncology and Critical Care, with Easyhaler and in Animal Health. With Orion's CNS medications, there are Phase IV-studies on-going.

Updated Dec 17th 2010
 

 

Check the R&D words

Blinding

Clinical study

Marketing authorization

Phase

Placebo