TRANSLATIONAL MEDICINE/DEVELOPMENT PROCESS
The connection between basic and clinical sciences is an essential part of translational medicine, the purpose of which is to translate the knowledge obtained from basic science into practical therapeutic applications for patients. This knowledge transfer is also often refered to as “bench-to-bedside”transition of scientific advancements into clinical applications. This framework of translational medicine is applied during the discovery and drug development process
of a specific antibody against a certain disease. It includes major steps such as identifying an important and viable pathophysiological target antigen to modify the disease in a beneficial way, producing mAbs with structural elements providing optimal PK, testing the mAb in non-clinical safety and efficacy models, and finally clinical studies in patients. An overview of the development phases for a molecule and various activities in the PK/PD/toxicology areas is outlined in Figure 6. Furthermore the critical components of the entire development process of mAbs from a PK/PD perspective are explained in details in the following sections.
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