Phases of the R&D process

Once a candidate has been identified in research and proposed for development, it goes through a well defined and regulated development process with the ultimate goal of assessing its clinical efficacy and safety. This process if successful culminates in approval of a drug by the corresponding Regulatory Authorities.

Preclinical Phase

The main objectives of this phase are to establish the non-clinical safety profile of the candidate molecule before initiating clinical studies in humans, and, to prepare the candidate in a pharmaceutical formulation suitable for administration into humans.

Clinical Medicine - Phase I

Clinical development commences with phase I, and overlaps with some of the long-term preclinical studies. The drug candidate is administered for the first time in human beings -usually healthy volunteers- in studies designed to obtain the maximum amount of information on the tolerability of the compound with the minimum exposure.

Clinical - Phase II

In phase II, the dose and treatment regimens with the candidate molecule are established with very strict criteria for the inclusion of patients. The principal objective is to assess the efficacy of the treatment in the main indication.

Clinical - Phase III

The efficacy and safety profile of the clinical candidate is expanded in phase III, with confirmatory trials involving a large number of patients.

Post-marketing - Phase IV

The clinical research process is completed with the phase IV trials. Studies are carried out -once the product is on the market- to gather more information on the drug's benefits and future possibilities.