The Drug Development Process and the Phases of Clinical Research
The reader should be aware of two semantic conventions we adopted in this chapter: first, the terms “research” and “development” are used interchangeably; second, the term “drug”, which technically only applies to compounds with proven efficacy and effectiveness, is also used to indicate compounds undergoing the development process, for which, by definition, efficacy and effectiveness have not be proven.
KeywordsClinical Development Maximum Tolerate Dose Therapeutic Area Pivotal Study Preclinical Development
Unable to display preview. Download preview PDF.