Ricerca e regolamentazione nell'economia dell'industria farmaceutica

This article provides a comprehensive framework of the common features of pharmaceutical research, with a particular focus on the developments brought about by the widespread affirmation of the biotechnological paradigm. The study follows a layout inspired by the current regulatory setting: applied research (i.e. research activities carried out in order to find out economically appealing compounds), preclinical development (i.e. tests run in order to obtain the formal authorization for human experimentation), clinic experimentation (i.e. studies conducted on either ill or sane human beings carried out till the achievement of a commercial license) and, lastly, production/commercial exploitation. For each phase the main technological features, the regulatory framework, and the strategic choices firms have to undertake are examined. The article also provides some general remarks on the relationships between the evolution in research techniques and the organization of pharmaceutical industry.