See Also: Phase 2a studies(health)
Phase 3 studies(health)
Phase 5 studies(health)
multivariate studies(medicine)
multicenter studies(medicine)
preclinical studies(medicine)
intervention studies(medicine)
his bundle studies(medicine)
immunofluorescent studies(medicine)
business studies(dictionary)

Phase 3 studies (health)


Multicentre studies in populations of perhaps 1000 to 3000 patients (or more) for whom the medicine is eventually intended. Phase 3 trials generate additional safety and efficacy data from relatively large numbers of patients in both controlled and uncontrolled designs and are used to support a PLA. Trials are also conducted in special groups of patients or under special conditions dictated by the nature of a particular medicine and/or disease. Phase 3 trials often provide much of the information needed for the package insert and labelling of the medicine.