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Grzegorz Galka replied to the topic Combination Product Phase I clinical Studies in the forum Introduction to Design Controls 9 years ago
Hi,
During the phase I clinical trials we can find out if the drug or medical device is safe to for people. In this initial phase of clinical trials small group of people is tested for couple of months. In most cases it is a group between 20 and 100 healthy volunteers who are receiving money for being part of the study. The study is intended to determine the effects of the device or the drug on people. During this phase the side effects when dosage is elevated are also recorded. On the average about 70% of devices and drugs is permitted to go to another phase.
Thanks