Leveraging Genomic Factors to Improve Benefit-Risk

Author:

Schuck RN1,Charlab R1,Blumenthal GM1

Affiliation:

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

Publisher

Wiley

Subject

General Pharmacology, Toxicology and Pharmaceutics,General Biochemistry, Genetics and Molecular Biology,General Medicine,General Neuroscience

Reference42 articles.

1. The role of adme pharmacogenomics in early clinical trials: Perspective of the industry pharmacogenomics working group (i-pwg);Tremaine;Pharmacogenomics,2015

2. Realities and expectations of pharmacogenomics and personalized medicine: Impact of translating genetic knowledge into clinical practice;Squassina;Pharmacogenomics,2010

3. FDA-NIH Biomarker Working Group BEST (Biomarkers, EndpointS, and other Tools) Resource (Internet). Silver Spring (MD): Food and Drug Administration (US); 2016-. Glossary 2016 https://www.ncbi.nlm.nih.gov/books/NBK338448/

4. Pharmacogenomics in the assessment of therapeutic risks versus benefits: Inside the United States Food and Drug Administration;Zineh;Pharmacotherapy,2011

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

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1. Biomarkers in drug development;Atkinson's Principles of Clinical Pharmacology;2022

2. Use of Titration as a Therapeutic Individualization Strategy: An Analysis of Food and Drug Administration–Approved Drugs;Clinical and Translational Science;2019-03-12

3. Considerations for Developing Targeted Therapies in Low-Frequency Molecular Subsets of a Disease;Clinical Pharmacology & Therapeutics;2018-02-23

4. Translating Precision;Clinical and Translational Science;2017-02-13

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