ABSTRACT
INTRODUCTION The previous chapters in this book have considered the theories and thermodynamic bases behind the generation of different solid phases, as well as some of the principal analytical techniques used to characterize them. The volume of literature devoted to pharmaceutically relevant solid forms is suffi ciently extensive to indicate its signifi cance to formulation and development sciences. The role of solid form selection and solid materials characterization as an essential aspect of preformulation has been reinforced as an early step in a feed-forward drug product development scheme (1), and is consistent with worldwide regulatory guidance documents and the FDA’s recent Critical Path Initiative.
