The Drug Development Process and the Phases of Clinical Research

Part of the Statistics for Biology and Health book series (SBH)


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.


Clinical Development Maximum Tolerate Dose Therapeutic Area Pivotal Study Preclinical Development 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.


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Copyright information

© Springer-Verlag Italia, Milano 2007

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