Considerations for Developing Targeted Therapies in Low-Frequency Molecular Subsets of a Disease

Author:

Schuck Robert N.1,Woodcock Janet2,Zineh Issam1,Stein Peter3,Jarow Jonathan2,Temple Robert2,Permutt Thomas4,LaVange Lisa4,Beaver Julia A.3,Charlab Rosane1,Blumenthal Gideon M.3,Dorff Sarah E.1,Leptak Christopher3,Lemery Steven3,Rogers Hobart1,Chowdhury Badrul3,Litwack E. David5,Pacanowski Michael1

Affiliation:

1. Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Center for Drug Evaluation and Research, U.S. Food and Drug Administration; Silver Spring Maryland USA

2. Center for Drug Evaluation and Research, U.S. Food and Drug Administration; Silver Spring Maryland USA

3. Office of New Drugs, Center for Drug Evaluation and Research, Center for Drug Evaluation and Research, U.S. Food and Drug Administration; Silver Spring Maryland USA

4. Office of Biostatistics, Office of Translational Sciences, Center for Drug Evaluation and Research, Center for Drug Evaluation and Research, U.S. Food and Drug Administration; Silver Spring Maryland USA

5. Office of In Vitro Diagnostics and Radiological Health, Center for Devices and Radiological Health, U.S. Food and Drug Administration; Silver Spring Maryland USA

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Reference29 articles.

1. U.S. Food and Drug Administration Table of Pharmacogenomic Biomarkers in Drug Labeling http://www.fda.gov/Drugs/ScienceResearch/ResearchAreas/Pharmacogenetics/ucm083378.htm 2017

2. Pharmacogenomics in the assessment of therapeutic risks versus benefits: inside the united states food and drug administration;Zineh;Pharmacotherapy,2011

3. Leveraging genomic factors to improve benefit-risk;Schuck;Clin. Transl. Sci.,2017

4. Next-generation medicines: past regulatory experience and considerations for the future;Pacanowski;Clin. Pharmacol. Ther.,2014

5. Clinical pharmacology and the catalysis of regulatory science: opportunities for the advancement of drug development and evaluation;Zineh;Clin. Pharmacol. Ther.,2013

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