Drug development

Drug development or Preclinical Development is the process of taking a new chemical lead through the stages necessary to allow it to be tested in human clinical trials.

Novel chemical entities (NCEs) which emerge from the process of drug discovery will have promising activity against a particular biological target thought to be important in disease, however little will be known about the safety, toxicity, pharmacokinetics and metabolism of this NCE. It is the function of drug development to assess all of these parameters. One of the major objectives of drug development is to make a recommendation of the dose and schedule to be used the first time a NCE is used in a human clinical trial ("First-in-Man", FIM).