ABSTRACT
The purpose of this chapter is to provide guidance for the pharmaceutical product development of sterile dosage forms. This chapter introduces specific formulation chapters 6 through 10. Chapter 11 provides some formulation case studies to help the reader review learning points.
THE PRODUCT DEVELOPMENT PROCESS Drug product development is a lengthy, expensive, and risky process. It is estimated that on average it takes $1.1 billion and 12.5 years to bring a single drug from concept to commercialization (1-3). Only 1 in 5000 new chemical compounds makes it to market and 80% of all investigational new drugs fail. Figure 5-1 summarizes the pathways and Table 5-1 summarizes the various specific tasks involved in taking a drug from its discovery through the product development and clinical testing stages until it is approved as a commercial product. This is an oversimplification of a very complex procedure for moving an active pharmaceutical ingredient from conception to commercialization. The key points to realize from this figure are the following:
