Chapter 33 – Discover a Drug Substance, Formulate, and Develop It to a Product

The progression of new pharmaceutical compounds leading to the selection of a drug candidate for development studies is a very complex and time-consuming process. This process begins with a discovery phase that includes a lead identification step followed by lead optimization resulting in a drug candidate selection. To ensure that this process is efficient, the selection of the drug candidate must be anticipated by the development team to prepare for synthesis scale-up to manufacture larger quantities of drug substance, preformulation and formulation development leading to the manufacture of the supplies for the clinical trials. The entire process from discovery to the development of a drug product for clinical trials requires significant effort involving a large team of scientists from different parts of the organization.