Systematic Review of Device Parameters and Design of Studies Bridging Biologic-Device Combination Products Using Prefilled Syringes and Autoinjectors

This study represents an initial attempt to identify the potential influencing factors on device bridging, including the characteristics of the device and the clinical pharmacology study. These findings may inform the combination produc t development strategy, specifically design considerations for device and PK comparability studies.
Source: The AAPS Journal - Category: Drugs & Pharmacology Source Type: research