ABSTRACT
The primary goal of research-based pharmaceutical organizations around the globe is to discover, develop, and procure regulatory approvals for marketing new drugs for the treatment or prevention of diseases in humans and animals. This chapter deals primarily with pharmaceutical considerations for the development of new chemical or molecular entities for human therapeutic applications. A comprehensive discussion of all pharmaceutical considerations in the design and development of every type of dosage forms or drug delivery systems for all available routes of administration is beyond the scope of this chapter; rather, it focuses on pharmaceutical considerations for dosage forms generally developed for preclinical safety and pharmacology assessment and early testing in humans. However, the information presented and the concepts covered in this chapter are applicable to the development of pharmaceutical drugs, biopharmaceutical products, and medical devices during most stages of the drug development process.
