REFERENCES
- Food and Drug Administration (FDA) Draft Guidance. (2012). Guidance for Industry on Enrichment Strategies for Clinical Trials to Support Approval of Human Drugs and Biological Products. December 2012. Available at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulation/Information/Guidances/UCM332181.pdf
- Freidlin, B., Korn, E. L. (2014). Biomarker enrichment strategies: Matching trial design to biomarker credentials. Nature Reviews Clinical Oncology 11:81–90; published online 26 November 2013.