Clinical Studies
Studies in humans
In the clinical development the aim is to prove the safety and efficacy of the drug in humans. Clinical studies are divided into Phases I-IV during the progress of the development program. Studies can be conducted in healthy volunteers and in volunteer patient populations - the participation of study subjects in clinical studies is always confidential and the subject can discontinue the participation any time.
The procedures of clinical studies are carefully designed. The process is strictly regulated by the authorities and the studies are carried out in the same way with any products:
Before a clinical study can be started, a favourable opinion on the study protocol and associated documents has to be obtained from an ethics committee, and the national medicines agency of the country must approve the study. The agency also supervises the progression of the clinical study. When the clinical study is completed, a report on the results and study conduct will be submitted to the agency. Orion is publishing all on-going clinical studies in the public register ClinicalTrials.gov.
| Clinical phase |
Study subjects |
Number of subjects |
Duration |
Aim to clarify the... |
| I Pharmacokinetics |
Healthy |
30-80 |
1 y |
kinetics and concentration of the drug in the body |
| II Proof-of-concept and dose finding |
Patients |
50-300 |
1-3 y |
preliminary efficacy of the drug in the illness |
| III Confirmatory studies |
Patients |
500-10000 |
> 3 y |
efficacy and safety |
| IV Studies after marketing authorisation |
Users |
As needed |
Varies |
additional aspects and safety |
Orion has its own Phase I unit, which is located next to the plant area in Espoo. The Phase I Unit conducts clinical studies in healthy volunteers and patients, and serves clinical development projects of Orion.
Clinical studies in animals
In developing a veterinary drug, the efficacy and safety are shown in the species, which the drug is targeted to. The pharmacokinetics and concentrations of the drug are at first investigated in healthy animals. Then the efficacy in the illness and the optimal dose are clarified with a small number (30-80) of sick animals. Clinical efficacy and safety is finally confirmed in a larger sample (50-300) of animal patients. The authorities also carefully control the veterinary clinical studies.
With veterinary producs it is also essential to clarify the user safety in case the owner or the caretaker of the animal is exposed. Consumer safety and environmental risk assessment are very important when developing medicines for animals.
Updated
Dec 17th 2010