The Pharmaceutical Background

Abstract

For medicine today, the ultimate goal of most research-based pharmaceutical and allied health care organisations around the world is to discover, develop and procure necessary regulatory approvals for marketing new drugs for treatment or prevention of diseases in humans and animals. Drug discovery and development involves a complex process from early discovery of a chemical entity to demonstration of its safety and effectiveness for specific therapeutic indication(s). Introduction of new drugs either could be in the form of new chemical entities, or from regulatory perspectives a drug might be considered ‘new’ because of changes in its composition, route of administration, recommended dosage or dosage form. This chapter will deal primarily with pharmaceutical considerations for development of new chemical entities only, which usually require the greatest amount of investigation for safety and clinical evaluation to demonstrate their effectiveness. A comprehensive discussion of all pharmaceutical considerations in the design and development of all dosage forms or drug delivery systems for all routes of administration is beyond the scope of this chapter. An overview of critical pharmaceutical considerations for dosage forms generally developed for preclinical and early human testing will be covered.