Regulatory Issues in the Co-Development of Oncology Drugs and Proteomic Tests: An Overview

  • Dave Li
  • Joseph Hackett
  • Maria Chan
  • Gene Pennello
  • Steve Gutman
Part of the Cancer Drug Discovery and Development book series (CDD&D)

Summary

In this article, we review some relevant issues in cancer proteomic biomarker development and validation for targeted cancer therapeutics with emphasis on the importance of developing a clearly stated intended use and indication for use, establishing a reliable laboratory measurement, using robust clinical study designs with representative patient populations and effective controls, and addressing issues of biological validations and potential bias associated with predictive biomarker validation.

Keywords

Cancer proteomics target therapy validation regulation 

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© Humana Press Inc. 2008

Authors and Affiliations

  • Dave Li
  • Joseph Hackett
  • Maria Chan
  • Gene Pennello
  • Steve Gutman

There are no affiliations available

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