Knowledge Management KM

For the purposes of this chapter, KM is defined as the marriage of science, bioinformatics, and computer technology to more effectively assess and utilize the ever increasing amounts of clinical pharmacology and biopharmaceutics data arising from drug development. As an example, modern NDAs may contain more than 60 CP and BP studies, and each study contains many more pieces of data than ever before. In order to conduct a meaningful and thorough analyses of these data and to learn as much as possible about the drug/drug product, industry and regulatory scientists will need the capability that computer visualization and analysis software can offer. Applying web-based data management will enable endusers to (1) use information across studies better, (2) make more efficient and informed decisions about benefit/risk, and (3) create learning databases that can be effectively queried to compare CP and BP attributes across drugs and therapeutic areas. Visualization software is also a powerful way to communicate important CP and BP information to those in other disciplines in order to make maximum use of the scientific data at hand.

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