ABSTRACT

This chapter focuses on new drug development in the United States. It begins with brief history of drug discovery and then moves on to how drugs are discovered. Pharmacy is about patients, drugs, caring about the patient, and the patient receiving the best drug. It is important to understand how drugs are discovered, developed, tested, and approved for use. Drug discovery and development start with a human need and are based on good science. Before a drug dosage form can be tested in animals, it must be determined how long it takes to dissolve and be available to the body. A generic drug is drug product that is an identical copy of active ingredients, formulation, and strength that is marketed by a company other than the company that did the original research on the drug product. The chapter concludes with information on the post marketing surveillance of drugs, generic drugs, over-the-counter drugs, and the future of drug discovery and development.