There are many considerations in the development of a monoclonal antibody as a therapeutic agent. In this eBook, we will use denosumab as a case study.
First we must understand the medical needs for a new agent. We will look at the efforts that were made to understand the biology underlying that disease and to develop an agent that could affect that biological process.
Then, we will look at how the safety and efficacy of the antibody was established, the regulatory steps that were negotiated to gain approval, and finally a look ahead to where this antibody may go in the future.
