Method for developing parenteral therapeutic product with drug delivery device through clinical trial

摘要

The method set out herein involves conducting clinical trial to develop parenteral therapeutic product with drug delivery device. The method comprises conducting a dose-finding clinical study using a variable dose drug delivery device to evaluate multiple clinical doses, wherein the variable dose drug delivery device is automatic, portable and for user self-administration. During the dose-finding clinical study, both the performance of the drug and the performance of the variable dose drug delivery device are evaluated.