Investigación y desarrollo de nuevos medicamentos: de la molécula al fármaco / Investigation and development of new drugs: from the molecule to drug

There are many stages and a large investment of both time and money involved in the process of research and development before a new drug can be prescribed for clinical use. Of the thousands of new molecular entities, only one or two are approved for commercialization, after having endured a trajectory of 12 to 15 years in clinical trials in both animals and humans, demonstrating their therapeutic effectiveness and safety. There are three large administrators of medicines that control the process of new drug registration, the FDA - Food and Drug Administration of the USA being the largest and most well known. This article is based on their model and details the various stages that the molecule must undergo before finally being administered to patients. The future holds many exciting promises for new drug development with the advent of the human genome project and other highly advanced technological methods. However, the main challenge still remains, which is to guarantee the access of basic medicines to the majority of the world's population that is still without them

Buenas prácticas clínicas / Good clinical practices

Good clinical practice is the pattern of international standards to assure ethical and scientific quality in the design, conduction and report of studies that involve human beings. These standards are applied in pharmaceutical research, since they came out as regulations to register new medications. Nowadays, they are accepted as standard procedures in clinical research. They are inforced in developed countries since more than a decade and are currently being implemented in Latin America, thanks to an initiative of the pharmaceutical industries. The saturation and high costs of clinical research in Europe and United States, render Latin America as a potential region to conduct clinical studies. FDA, Europe and Japan accept data from abroad, if the studies are conducted following the norms of good clinical practice. It is therefore important that Chilean research centers and researchers become familiar with these norms and be prepared for their implementation