Pharmaceutical Development

Today’s fast moving pharmaceutical market requires more efficient drug development and production. Pharmaceutical development is intended to design a quality product and a manufacturing process that can consistently deliver the product with its intended performance. A pharmaceutical product should be designed to meet patients’ needs.

The knowledge and information acquired from pharmaceutical development studies and manufacturing experience offer scientific understanding to support the establishment of the design space, specifications, and manufacturing controls. A more systematic approach to development (also defined as quality by design) can include, for example, incorporation of prior knowledge, results of studies using design of experiments, use of quality risk management, and use of knowledge management throughout the lifecycle of the product.

The present chapter focuses on the key areas of pharmaceutical development currently followed in the pharmaceutical industry.