This phase comprises both test tube trials using cell cultures as well as testing in animal models to identify new active substances. Dosing, responses, galenics and pharmaceutical forms are also aspects investigated during this phase. Duration: 3-5 years.
In this phase, the tolerability of the substance identified and tested in the pre-clinical phase is evaluated. The key factors are uptake, processing and excretion. The trials involve small numbers of healthy subjects.
In Phase II studies, the first tests of treatment of a disease using the new substance are carried out. Efficacy, tolerability and appropriate dosing are the focus.
In the trials of Phase III studies, the new substance is compared against known, marketable drugs in terms of efficacy and tolerability. Phase III involves greater numbers of patients than Phase II, allowing the new substance to obtain the regulatory approval required to launch on the market.
The drug that has now been approved is reviewed for rare adverse effects using large numbers of patients. The product may also prove beneficial in the treatment of other known disorders.
Since 1998, Intermed carries out phase II-IV treatment studies.