ABSTRACT
INTRODUCTION The development of regulatory framework for the regulation of nanomaterials is critical to the future of virtually every potential application of what is commonly referred to as nanotechnology. It is vital that the regulatory process be coherent and avoid mistakes made in developing regulatory frameworks for recent innovations, such as nanotechnology and agricultural biotechnology, to ensure the development of new uses, as well as public confidence (1). Although standards of care have been established, accurate prediction of the effects, both therapeutic and toxic, of a given therapeutic system on a given patient is frustrated by a host of cellular resistance mechanisms that yield disappointing differentials between in vitro predictions and in vivo results (2). Computational models may bridge the gap between the two, producing highly realistic and predictable therapeutic results. The power of such models over in vitro monolayer and even spheroid assays lies in their ability to integrate the complex in vivo interplay of phenomena such as diffusion through lesion, heterogeneous lesion growth, apoptosis, necrosis, and cellular uptake, efflux, and target binding. This chapter covers in vitro drug release process from particulate (micro/nano) drug carriers. The discussion is about nanoparticle cell interactions; various techniques used for immunoassays are discussed in later parts of this book.
