Administration in the clinic

Many of the biotherapeutics, including most of the monoclonal antibodies (mAbs) for various cancer indications, are dosed intravenously in the form of admixtures with suitable diluents. Therefore admixture compatibility and stability studies, which may include evaluation of the compatibility and in-use stability of the drug product with the diluents as well as the dosing/delivery devices, are key requirements from the regulatory agencies during the pharmaceutical development process. In spite of their high relevance, there is a lack of literature available for scientists and the drug development community to provide guidance on the design and execution of these admixture compatibility and stability studies. The purpose of this chapter is to discuss the general aspects of the admixture compatibility and stability studies which can be used as guidelines and adapted according to the needs of the individual program.