Phase III trials are the largest clinical studies, conducted with hundreds or thousands of patients in multiple locations over a period of years. The safety and efficacy data generated by Phase III studies are a critical element of the dossier needed to get a drug approved by regulatory authorities.
In 2011, Nycomed successfully completed phase III development for three projects. Alendronate effervescent, Teduglutide (Revestive®) and Ciclesonide HFA are now in
registration.