Phase II clinical studies, or proof of concept studies, begin to test the effect of a medicine on the target disease in humans. These studies are usually run as...
Phase I clinical studies, or proof of mechanism studies, test the safety of a medicine in humans. Usually, these studies are carried out in healthy human volunteers.
Phase III clinical studies, or confirmatory studies, are the final confirmation of the safety and efficacy of a medicine before it can be launched on the market. Phase III...
After Phase III of clinical studies, all the information on a medicin is collected and organised in a pre-determiend format (a dossier), which is then submitted to the regulatory...
Life-cycle management activities begin as soon as a medicine receives authorisation from the regulatory authorities. Research on the medicine continues in order to gather additional data on safety and...
