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https://www.fda.gov/media/121320/download
Enrichment Strategies for Clinical Trials to Support Determination of Effectiveness of Human Drugs and Biological Products . Guidance for Industry
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enrichment-strategies-clinical-trials-support-approval-human-drugs-and-biological-products
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “Enrichment Strategies for Clinical Trials to Support Demonstration of ...
https://www.federalregister.gov/documents/2019/03/15/2019-04815/enrichment-strategies-for-clinical-trials-to-support-demonstration-of-effectiveness-of-human-drugs
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Enrichment Strategies for Clinical Trials to Support Demonstration of Effectiveness of Human Drugs and Biological Products.'' The purpose of this guidance is to assist...
https://www.federalregister.gov/documents/2013/02/04/2013-02293/draft-guidance-for-industry-on-enrichment-strategies-for-clinical-trials-to-support-approval-of
The Food and Drug Administration (FDA) is extending the comment period for the draft guidance for industry entitled ``Enrichment Strategies for Clinical Trials to Support Approval of Human Drugs and Biological Products'' that appeared in the Federal Register of December 17, 2012 (77 FR 74670). In...
https://www.nature.com/articles/nrclinonc.2013.218
Nov 26, 2013 · Enrichment strategies for clinical trials to support approval of human drugs and biological products, (2012). 2 Temple, R. Enrichment of clinical study populations.Cited by: 120
http://www.fdalawblog.net/2012/12/fda-releases-draft-guidance-on-enrichment-strategies-for-clinical-trials/
By Alexander Varond –. On December 14, FDA released a draft guidance document entitled “Enrichment Strategies for Clinical Trials to Support Approval of Human Drugs and Biological Products” (“Enrichment Guidance”). The thirty-nine-page document was more than six years in the making and aims to provide “guidance to industry on enrichment strategies that can be used in clinical ...
https://www.ncbi.nlm.nih.gov/pubmed/28933670
On Enrichment Strategies for Biomarker Stratified Clinical Trials. Wang X(1), Zhou J(1), Wang T(2), George SL(1). Author information: (1)a Department of Biostatistics and Bioinformatics , Duke University , Durham , NC , U.S.A . (2)b Department of Biostatistics , University of North Carolina at Chapel Hill , Chapel Hill , NC , U.S.A .Cited by: 3
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