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Vaccines, Blood & Biologics

Evaluation of Bioinformatics Tools for the Analysis of Pharmacogenomic and Proteomic Data from Regulatory Clinical and Non-clinical Studies

Principal Investigator: Jawahar Tiwari
Office / Division: OBE / DB


Public Health Issue: New bioinformatics tools and software are appearing commercially and as freeware. Since these tools make use of emerging statistical and mathematical models, studying the assumptions and methods used (in particular the robustness of these methods) is needed.

Regulatory Contribution: It is important to be able to provide authoritative advice to reviewers and sponsors about methods to evaluate bioinformatics tools for assessing pharmacogenomic and proteomic data for regulatory submissions. Providing appropriate advice to clinical and product reviewers is a major regulatory contribution.

Research Approach: The goal of this research is to evaluate software for pharmacogenomic or proteomic data from clinical or non-clinical studies that is submitted to the FDA. This research program provides the basis for detailed evaluation of current software for microarrays and proteomics submissions. It will give recommendations regarding the usability and appropriateness of many software tools in this area.

Mission Relevance and Outcomes: This research provides the basis for appropriate advice to FDA and sponsors on current software in the review process for pharmacogenomics and proteomics applications.


Genomics 2006 Apr;87(4):552-9
Quality prediction of cell substrate using gene expression profiling.
Han J, Farnsworth RL, Tiwari JL, Tian J, Lee H, Ikonomi P, Byrnes AP, Goodman JL, Puri RK

Contact FDA

(800) 835-4709
(240) 402-8010
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Food and Drug Administration

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Building 71 Room 3103

Silver Spring, MD 20993-0002

Page Last Updated: 01/22/2015
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