Clinical trials drug development process

Table 2.4. The range of major tests undertaken on a potential new drug during pre-clinical trials. The emphasis at this stage of the drug development process is upon assessing safety. Satisfactory pharmacological, and particularly toxicological, results must be obtained before any regulatory authority will permit commencement of human trials...

Both the EMEA and the EDA have recognised the need to streamline the drug development process in order to bring new medicines to patients more rapidly see for example FDA (2004) Critical Path Initiative . The FDA raise (FDA (2006) Critical Path Opportunities List ) a number of statistical issues that need to be resolved in order to help make the clinical trials process more efficient ... 

The possibility of bench testing for screening potential pharmaceutical active substances for confirmation of the outcomes of silicon tests. This may shorten the time frame to reach clinical trials for potential drug candidates and allow a more systematic drug development process... 

The drug development program is divided into preclinical development, clinical development, and post-approval surveillance. Several preclinical and clinical trials are conducted during this program. In the following the phases of the clinical drug development process are described with a special focus on the data available for modeling and simulation and some objectives are exemplarily listed for the respective phases. 

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