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The most critical phase of development is undoubtedly the clinical trials on humans. These trials generally start with the examination of pharmacological effects in a limited number of healthy volunteers (phase I) in hospitals.

Tolerance is also being evaluated and the metabolic rate of the new molecule is being studied. If the results are conclusive, the decision is made to verify the effectiveness of the new molecule or the new dosage form in a limited number of patients, and to compare it with a placebo or reference products already on the market (Phase II).

In the next phase, these studies are extended to larger groups of patients that show a more complex profile (pathologies and/or other related drugs) (Phase III).

All these studies generate data that are needed for the registration file. Once the marketing authorization has been granted, further studies may be carried out with a view to examining new therapeutic indications and to define new target groups or to evaluate the safety profile in more detail.

The quality of Belgian clinicians and "favorable" legislation are recognized and many clinical studies are carried out in our country. In Europe, Belgium is the country with the most clinical trials per capita. Special care is required in the preparation, implementation and documentation of such clinical work.

Companies set up multidisciplinary teams where pharmacists have key roles in the organization and the follow-up of studies, the monitoring, the quality and analysis of their results. The rules pertaining to clinical trials are included in the Good Clinical Practices (GCPs).

There are also more and more service that companies are offering such as their cooperation in the field of clinical research, by definition an international activity, and for which Belgium has certain assets such as its central position in Europe and its highly qualified personnel. More than 5800 people are active in research in Belgium.