Drugs

Biomarker Qualification Case Studies

Biomarker Qualification

Collaborative Effort to Qualify a Drug Development Tool

When a woman’s husband is diagnosed with osteoporosis, she sets out to learn how she can help. This case study follows her as she works with other patient advocates, researchers, and FDA to qualify a biomarker that will make clinical trials on new osteoporosis drugs more efficient. Along the way, she learns about the Biomarker Qualification Program and speaks to patients, advocacy groups, and drug developers about the potential of biomarkers to improve the drug development process.

FDA Case Study 2

Learning Objectives:

  • Understand the potential benefits of biomarker qualification in drug development.
  • Understand the collaborative efforts involved in the qualification of a biomarker and the role that patient advocates can play in the process.

Download Biomarker Qualification—Collaborative Effort to Qualify a Drug Development Tool case study (PDF - 186 KB).

Page Last Updated: 08/14/2017
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