New Drug Development

Abstract

The word drug has various connotations in everyday language. In this book, it refers specifically to traditional pharmaceuticals and biopharmaceuticals (biologicals) that safely and effectively treat or prevent biological states of clinical concern. The text discusses the development of new ethical drugs, drugs that must be prescribed by a physician. In the case of small molecule drugs, attention focuses on the development of a drug containing a novel chemical compound, i.e., a new chemical entity (NCE) or new molecular entity (NME), as its active ingredient. In the case of biologicals, attention focuses on proteins that are produced via the large-scale cultivation of microbial or mammalian cells.

The engine that drives new drug development is an unmet medical need, which is ultimately an unmet biological need…Study design, experimental methodology, operational execution, and statistical analysis are central characters whose importance lies in their capacity to develop drugs that change a patient’s biology for the better.