ABSTRACT
This chapter presents the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Harmonized Tripartite Guideline recommendations and framework of methodologies and advanced tools which can be used to reach the top of the pyramid of knowledge. Building the pyramid of knowledge is an important stimulus toward development of a solid framework for powder systems. Since the majority of drug delivery systems involve powders, the challenges facing the formulation scientist may be the toughest in the area of powder technology. Pharmaceutical powder technology incorporates many areas where the critical properties of powders must be well defined for the development of a robust formulation and manufacturing process. The formulation design space can be efficiently described by an experimental design. The power consumption profile is useful as an analytical tool to define S values for different formulation.
