Biomedical Engineering Reference
In-Depth Information
begins with the release of the drug, involves monitoring patients for adverse reactions. The FDA
approves only about 1 molecule in 5 that makes it to Phase I clinical trials.
As illustrated in the bottom half of
Figure 9-2
, modeling and simulation techniques can also be
applied to various aspects of the drug development process. For example, process modeling can be
used, starting around year nine of the drug discovery and development process, to develop the most
efficient and cost-effective development processes. Similarly, the manufacturing process can be
modeled to determine the best use of materials, product stability, and best method of product
synthesis—all without modifying the actual process. Before delving into one of the key modeling and
simulation areas, protein structure determination and prediction, consider the following review of the
fundamentals of modeling and simulation.
