Introduction: Defining the Position of Non-Biological Complex Drugs

In the first chapter of this book the concept of non-biological complex drugs (NBCDs) is introduced. These are complex drug products but don’t fall in the category of ‘biologicals’. NBCDs were earlier defined as: medicinal products, not being a biological medicine, where the active substance is not a homo-molecular structure, but consists of different (closely related and often nanoparticulate) structures that cannot be isolated and fully quantitated, characterized and/or described by physicochemical analytical means. The composition, quality and in vivo performance of NBCD are highly dependent on the manufacturing processes of the active ingredient as well as (in most cases) the formulation (Crommelin et al. 2014). Examples of NBCDs are iron-carbohydrate complexes, glatiramoids, liposomes, polymeric micelles, swelling polymers and many (other) nanomedicines. A number of these (and related) NBCD-families are dealt with in 8 chapters of this book. As complex drug products request sophisticated analytical means for characterization of their structure and in vivo performance, ample attention is paid to the analytical challenges in two separate chapters. Finally, a perspective regarding NBCDs is given from the regulatory side.