1. Information systems for surrogate biomarkers.
- Author
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Hehenberger, Michael, Chatterjee, Avijit, Sprengel, Jörg, and Yoo, Christopher
- Subjects
BIOMARKERS ,INFORMATION resources ,BIOCHEMISTRY ,INFORMATION science - Abstract
Biopharmaceutical industry is incorporating biomarker concepts throughout the R&D processes, including the inclusion of biomarker-related data in the submission of new drug applications. In this paper we discuss the role of IT and information systems that support incorporation of surrogate biomarkers in the clinical development process, with emphasis on new molecular imaging technologies and associated IT requirements. In addition, we discuss how recently introduced FDA standards regarding submission data and FDA guidance documents related to genomic and imaging data can be accommodated in a solution architecture for (surrogate) biomarker-based clinical development. [Copyright &y& Elsevier]
- Published
- 2005
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