Phases of research

In drug research studies the following phases are identified:

Phase Characteristics
0 with a small group of healthy subjects: in a very early phase of the development of the product, based on limited preclinical toxicological research, in very low doses, in which no pharmacological effect is expected.
 I Human pharmacological: First administration in humans, generally in a small number of healthy volunteers. Tolerability and safety are investigated, generally by increasing doses. Often also an evaluation of pharmacodynamics and pharmacokinetics takes place.
II Explorative therapeutic: research into the activity in (a small number of) patients suffering from a particular medical ailment. Verification of the working mechanism in patients or healthy volunteers and of the safety when used for a short period of time.
III Confirmative therapeutic: testing the final dosage in medical practice on its usability and effectiveness in a larger number of patients. Comparison with an existing product or placebo. Safety in the short and longer terms are also investigated.
IV Research after authorisation and related to the indication area for which the product is authorised. These types of studies are not necessary for authorisation purposes, but are important for optimalisation of the use of the medicinal product.

Source: CCMO

Foundation Beoordeling Ethiek Biomedisch Onderzoek