Phase 1 clinical studies are done on a small group of participants after the drug or treatment has been proved safe on animals. Doctors use this phase to establish a good dosage range as well as collect data on the effects of the drug or treatment and its safeness. Clinical studies are a part of the validation process in design controls. If a product fails to meet the design input requirements during the design
validation effort, it will be necessary to revise the design or manufacturing processes. The purpose of design transfer is to ensure product designs are transferred into manufacturing specifications. There are no design transfer activities associated with phase 1 clinical studies because there are done on only a small population. The clinical studies need to advance to the later phases and be tested on more people before design transfer comes into play.