Preclinical research

Preclinical research is the laboratory and animal work that has to support a candidate before any person is given it: pharmacology, toxicology, and the data that justify a starting dose in humans. Regulators authorise first-in-human testing on the strength of it, through an Investigational New Drug application in the United States or a clinical trial authorisation in the European Union.

This is also where a great many promising findings stop, and where results are most often reported as though they applied to people. Our coverage is explicit about the distance between a result in a model and a result in a patient.